Canakinumab Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Canakinumab comprises 90 peer-reviewed publications across 15 journals, 41 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Atherosclerosis, Schnitzler Syndrome, Cryopyrin-Associated Periodic Syndromes, and Arthritis, Juvenile. Most recent publication: Covariate Adjustment for the Win Odds: Application to Cardiovascular Outcomes Trials., Stat Med, 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. IL-1 Signal Inhibition In Alcoholic Hepatitis (ISAIAH): a study protocol for a multicentre, randomised, placebo-controlled trial to explore the potential benefits of canakinumab in the treatment of alcoholic hepatitis.
    Vergis N, Patel V, Bogdanowicz K, et al. · Trials · 2021
    PubMed: PMID 34763711 · NCT03775109 (ISAIAH) · Alcoholism
  2. Canakinumab reduces the risk of acute gouty arthritis flares during initiation of allopurinol treatment: results of a double-blind, randomised study.
    Schlesinger N, Mysler E, Lin HY, et al. · Ann Rheum Dis · 2011
    PubMed: PMID 21540198 · NCT00927810 · Arthritis, Gouty
  3. Interleukin-1 antagonism in type 1 diabetes of recent onset: two multicentre, randomised, double-blind, placebo-controlled trials.
    Moran A, Bundy B, Becker DJ, et al. · Lancet · 2013
    PubMed: PMID 23562090 · NCT00947427 (TN14) · Diabetes Mellitus, Type 1
  4. Safety and efficacy of canakinumab in Japanese patients with phenotypes of cryopyrin-associated periodic syndrome as established in the first open-label, phase-3 pivotal study (24-week results).
    Imagawa T, Nishikomori R, Takada H, et al. · Clin Exp Rheumatol · 2013
    PubMed: PMID 23380020 · NCT00991146 · Cryopyrin-Associated Periodic Syndromes
  5. Canakinumab for the treatment of children with colchicine-resistant familial Mediterranean fever: a 6-month open-label, single-arm pilot study.
    Brik R, Butbul-Aviel Y, Lubin S, et al. · Arthritis Rheumatol · 2015
    PubMed: PMID 25049046 · NCT01148797 (CONTROL FMF)
  6. TET2-Driven Clonal Hematopoiesis and Response to Canakinumab: An Exploratory Analysis of the CANTOS Randomized Clinical Trial.
    Svensson EC, Madar A, Campbell CD, et al. · JAMA Cardiol · 2022
    PubMed: PMID 35385050 · NCT01327846 (CANTOS) · Atherosclerosis
  7. Long-term efficacy and safety of canakinumab in patients with mevalonate kinase deficiency: results from the randomised Phase 3 CLUSTER trial.
    Jeyaratnam J, Simon A, Calvo I, et al. · Rheumatology (Oxford) · 2022
    PubMed: PMID 34554243 · NCT02059291
  8. Long-Term Efficacy and Safety of Canakinumab in Patients With Tumor Necrosis Factor Receptor-Associated Periodic Syndrome: Results From a Phase III Trial.
    Gattorno M, Obici L, Penadés IC, et al. · Arthritis Rheumatol · 2024
    PubMed: PMID 37668289 · NCT02059291

Primary-outcome results across pivotal trials

Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.

TrialIndicationPrimary endpointArmValue
NCT00685373Cryopyrin-Associated Periodic SyndromesThe Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs), Discontinuation of Study Drug Due to an AE, Infections and Infestations and Injection Site Reactions
2 years depending on when the participant enters the study
Canakinumab (ACZ885)0 participants
Canakinumab (ACZ885)2 participants
Canakinumab (ACZ885)18 participants
Canakinumab (ACZ885)150 participants
Canakinumab (ACZ885)4 participants
Canakinumab (ACZ885)109 participants
Canakinumab (ACZ885)13 participants
Canakinumab (ACZ885)11 participants
NCT00770601Cryopyrin-Associated Periodic SyndromesPercentage of Participants With Complete Remission and Relapse After 6 Months of Canakinumab Treatment.
6 months
Canakinumab (ACZ885)0 Percentage of participants
NCT00886769
β-SPECIFIC 1
Arthritis, JuvenilePercentage of Patients Who Meet the Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria
Baseline, Day 15, Day 29
Canakinumab79.1 percentage of participants
Canakinumab83.7 percentage of participants
Placebo9.8 percentage of participants
Placebo9.8 percentage of participants
NCT00889863
β-SPECIFIC 2
Arthritis, JuvenilePart I: Percentage of Patients Who Were on Steroids at Entry Into Part I and Who Were Able to Taper Steroid as Per Protocol in at Least 25% of the Patients Who Entered the Study Taking a Steroid
32 Weeks
Canakinumab44.5 Percentage of participants
NCT00889863
β-SPECIFIC 2
Arthritis, JuvenilePart II: Survival Estimate of Time to Flare
Part II was event driven. The study was stopped when the required number of 37 flares had occurred (88 weeks)
CanakinumabNA Days
Placebo236.0 Days
NCT00891046
β-SPECIFIC 3
Arthritis, JuvenileNumber of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs by Severity, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Treatment Related AEs and SAE
From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)
ACZ885 Treated47 participants
ACZ885 Treated137 participants
ACZ885 Treated18 participants
ACZ885 Treated14 participants
ACZ885 Treated57 participants
ACZ885 Treated4 participants
ACZ885 Treatment Naive13 participants
ACZ885 Treatment Naive14 participants
ACZ885 Treatment Naive44 participants
ACZ885 Treatment Naive108 participants
ACZ885 Treatment Naive1 participants
ACZ885 Treatment Naive40 participants
NCT00891046
β-SPECIFIC 3
Arthritis, JuvenileNumber of Participants With Anti -ACZ885 Antibodies at Any Visit During the Study
From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)
ACZ885 Treated0 participants
ACZ885 Treatment Naive0 participants
NCT00891046
β-SPECIFIC 3
Arthritis, JuvenileNumber of Participants With Clinically Significant Local Injection Site Reactions During the Study
From start of study treatment (Day 1) up to end of follow-up period (Week 271 for ACZ885 treated participants and Week 145 for ACZ885 treatment naive participants)
ACZ885 Treated15 participants
ACZ885 Treated3 participants
ACZ885 Treated129 participants
ACZ885 Treated0 participants
ACZ885 Treatment Naive6 participants
ACZ885 Treatment Naive115 participants
ACZ885 Treatment Naive2 participants
ACZ885 Treatment Naive0 participants
NCT00891046
β-SPECIFIC 3
Arthritis, JuvenilePercentage of Participants Previously Treated With Anakinra Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
ACZ885 Treatment Naive: Group 157.7 Percentage of participants
ACZ885 Treatment Naive: Group 169.2 Percentage of participants
ACZ885 Treatment Naive: Group 176.9 Percentage of participants
ACZ885 Treatment Naive: Group 180.8 Percentage of participants
ACZ885 Treatment Naive: Group 180.8 Percentage of participants
ACZ885 Treatment Naive: Group 291.7 Percentage of participants
ACZ885 Treatment Naive: Group 291.7 Percentage of participants
ACZ885 Treatment Naive: Group 291.7 Percentage of participants
ACZ885 Treatment Naive: Group 291.7 Percentage of participants
ACZ885 Treatment Naive: Group 291.7 Percentage of participants
ACZ885 Treatment Naive: Group 392.3 Percentage of participants
ACZ885 Treatment Naive: Group 3100 Percentage of participants
ACZ885 Treatment Naive: Group 376.9 Percentage of participants
ACZ885 Treatment Naive: Group 3100 Percentage of participants
ACZ885 Treatment Naive: Group 369.2 Percentage of participants
ACZ885 Treatment Naive: Group 490 Percentage of participants
ACZ885 Treatment Naive: Group 492.9 Percentage of participants
ACZ885 Treatment Naive: Group 480 Percentage of participants
ACZ885 Treatment Naive: Group 495.7 Percentage of participants
ACZ885 Treatment Naive: Group 464.3 Percentage of participants
NCT00891046
β-SPECIFIC 3
Arthritis, JuvenilePercentage of Participants Previously Treated With Other Biologics Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
ACZ885 Treatment Naive: Group 193.3 Percentage of participants
ACZ885 Treatment Naive: Group 160 Percentage of participants
ACZ885 Treatment Naive: Group 196.7 Percentage of participants
ACZ885 Treatment Naive: Group 183.3 Percentage of participants
ACZ885 Treatment Naive: Group 186.7 Percentage of participants
ACZ885 Treatment Naive: Group 350 Percentage of participants
ACZ885 Treatment Naive: Group 350 Percentage of participants
ACZ885 Treatment Naive: Group 350 Percentage of participants
ACZ885 Treatment Naive: Group 350 Percentage of participants
ACZ885 Treatment Naive: Group 3100 Percentage of participants
ACZ885 Treatment Naive: Group 491.0 Percentage of participants
ACZ885 Treatment Naive: Group 477.5 Percentage of participants
ACZ885 Treatment Naive: Group 491.0 Percentage of participants
ACZ885 Treatment Naive: Group 468.5 Percentage of participants
ACZ885 Treatment Naive: Group 488.8 Percentage of participants
NCT00891046
β-SPECIFIC 3
Arthritis, JuvenilePercentage of Participants Previously Treated With Tocilizumab Who Achieved Minimum Response of American College of Rheumatology (ACR) Pediatric 30/50/70/90/100 at Last Assessment of Study
Baseline up to last assessment (4 years) or date of discontinuation, which ever occurred earlier
ACZ885 Treatment Naive: Group 188.5 Percentage of participants
ACZ885 Treatment Naive: Group 192.3 Percentage of participants
ACZ885 Treatment Naive: Group 188.5 Percentage of participants
ACZ885 Treatment Naive: Group 188.5 Percentage of participants
ACZ885 Treatment Naive: Group 165.4 Percentage of participants
ACZ885 Treatment Naive: Group 266.7 Percentage of participants
ACZ885 Treatment Naive: Group 2100 Percentage of participants
ACZ885 Treatment Naive: Group 2100 Percentage of participants
ACZ885 Treatment Naive: Group 2100 Percentage of participants
ACZ885 Treatment Naive: Group 266.7 Percentage of participants
ACZ885 Treatment Naive: Group 3100 Percentage of participants
ACZ885 Treatment Naive: Group 30 Percentage of participants
ACZ885 Treatment Naive: Group 350 Percentage of participants
ACZ885 Treatment Naive: Group 3100 Percentage of participants
ACZ885 Treatment Naive: Group 3100 Percentage of participants
ACZ885 Treatment Naive: Group 492.2 Percentage of participants
ACZ885 Treatment Naive: Group 486.7 Percentage of participants
ACZ885 Treatment Naive: Group 476.7 Percentage of participants
ACZ885 Treatment Naive: Group 467.8 Percentage of participants
ACZ885 Treatment Naive: Group 491.1 Percentage of participants
NCT00900146Diabetes Mellitus, Type 2Change From Baseline in Hemoglobin A1c (HbA1c) at Month 4 During Dose-finding Period of the Study (Period II)
Baseline, Month 4
Canakinumab 15 mg + Metformin-0.29 percentage of hemoglobin A1c (±0.071 Standard Error)
Canakinumab 150 mg + Metformin-0.25 percentage of hemoglobin A1c (±0.071 Standard Error)
Canakinumab 5 mg + Metformin-0.19 percentage of hemoglobin A1c (±0.072 Standard Error)
Canakinumab 50 mg + Metformin-0.31 percentage of hemoglobin A1c (±0.073 Standard Error)
Placebo + Metformin-0.13 percentage of hemoglobin A1c (±0.053 Standard Error)
NCT00900146Diabetes Mellitus, Type 2Number of Participants With Adverse Events (AEs), Serious Adverse Events, Death and Clinical Significant AEs During 4 Months (Period II)
4 months (Period II)
Canakinumab 15 mg + Metformin43 Participants
Canakinumab 15 mg + Metformin1 Participants
Canakinumab 15 mg + Metformin0 Participants
Canakinumab 150 mg + Metformin0 Participants
Canakinumab 150 mg + Metformin43 Participants
Canakinumab 150 mg + Metformin5 Participants
Canakinumab 5 mg + Metformin2 Participants
Canakinumab 5 mg + Metformin0 Participants
Canakinumab 5 mg + Metformin33 Participants
Canakinumab 50 mg + Metformin2 Participants
Canakinumab 50 mg + Metformin0 Participants
Canakinumab 50 mg + Metformin45 Participants
Placebo + Metformin6 Participants
Placebo + Metformin0 Participants
Placebo + Metformin76 Participants
NCT01029652
β-RELIEVED
GoutNumber of Participants With Adverse Events (AE), Death and Serious Adverse Events (24 Weeks Overall)
24 weeks overall
Canakinumab 150 mg0 Participants
Canakinumab 150 mg11 Participants
Canakinumab 150 mg71 Participants
Triamcinolone Acetonide 40 mg6 Participants
Triamcinolone Acetonide 40 mg56 Participants
Triamcinolone Acetonide 40 mg1 Participants
NCT01029652
β-RELIEVED
GoutNumber of Participants With Adverse Events (AE), Death and Serious Adverse Events (72 Weeks Overall)
72 weeks overall
All Randomized to Canakinumab76 Participants
All Randomized to Canakinumab19 Participants
All Randomized to Canakinumab1 Participants
Randomized to Canakinumab :After Re-treated With Canakinumab8 Participants
Randomized to Canakinumab :After Re-treated With Canakinumab1 Participants
Randomized to Canakinumab :After Re-treated With Canakinumab38 Participants
Randomized to Canakinumab :Before Re-treated With Canakinumab6 Participants
Randomized to Canakinumab :Before Re-treated With Canakinumab41 Participants
Randomized to Canakinumab :Before Re-treated With Canakinumab0 Participants
Randomized to Triam: After Switched to Canakinumab0 Participants
Randomized to Triam: After Switched to Canakinumab19 Participants
Randomized to Triam: After Switched to Canakinumab0 Participants
Randomized to Triam: Before Switched to Canakinumab0 Participants
Randomized to Triam: Before Switched to Canakinumab2 Participants
Randomized to Triam: Before Switched to Canakinumab20 Participants
Randomized to Triamcinolone Acetonide (Triam)11 Participants
Randomized to Triamcinolone Acetonide (Triam)2 Participants
Randomized to Triamcinolone Acetonide (Triam)60 Participants
NCT01029652
β-RELIEVED
GoutSelf-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (0-100mm VAS)
72 hours post-dose (randomization)
Canakinumab 150 mg28.1 mm (±2.42 Standard Error)
Triamcinolone Acetonide 40 mg39.5 mm (±2.44 Standard Error)
NCT01029652
β-RELIEVED
GoutTime to First New Flare
12 weeks
Canakinumab 150 mgNA Days
Canakinumab 150 mgNA Days
Triamcinolone Acetonide 40 mg119 Days
Triamcinolone Acetonide 40 mgNA Days
NCT01080131
β-RELIEVED-II
GoutNumber of Participants With Adverse Events, Death and Serious Adverse Events (72 Weeks Overall)
72 weeks
All Canakinumab85 participants
All Canakinumab12 participants
All Canakinumab1 participants
All Triamcinolone Acetonide4 participants
All Triamcinolone Acetonide0 participants
All Triamcinolone Acetonide70 participants
Canakinumab: After Retreatment5 participants
Canakinumab: After Retreatment39 participants
Canakinumab: After Retreatment0 participants
Canakinumab: Before Retreatment44 participants
Canakinumab: Before Retreatment1 participants
Canakinumab: Before Retreatment0 participants
Triam: After Switch to Canakinumab3 participants
Triam: After Switch to Canakinumab27 participants
Triam: After Switch to Canakinumab0 participants
Triam: Before Switch to Canakinumab0 participants
Triam: Before Switch to Canakinumab0 participants
Triam: Before Switch to Canakinumab29 participants
NCT01080131
β-RELIEVED-II
GoutNumber of Participants With Adverse Events, Death and Serious Adverse Events During 24 Weeks
During 24 weeks overall
Canakinumab 150 mg78 Participants
Canakinumab 150 mg1 Participants
Canakinumab 150 mg7 Participants
Triamcinolone Acetonide 40 mg0 Participants
Triamcinolone Acetonide 40 mg2 Participants
Triamcinolone Acetonide 40 mg65 Participants
NCT01080131
β-RELIEVED-II
GoutSelf-assessed Pain Intensity in the Joint Most Affected at Baseline Measured on a Visual Analog Scale (VAS) at 72 Hours Post-dose
72 hours post-dose (randomization)
Canakinumab 150 mg22.1 mm (±2.33 Standard Error)
Triamcinolone Acetonide 40 mg31.9 mm (±2.35 Standard Error)
NCT01080131
β-RELIEVED-II
GoutTime to First New Flare: Survival Analysis During the 12 Weeks of Study
Baseline to 12 weeks
Canakinumab 150 mgNA Days
Triamcinolone Acetonide 40 mgNA Days
NCT01327846
CANTOS
AtherosclerosisAnalysis of Core Phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and Its Components
From randomization, to end of treatment plus 30 days, up to approximately 6 years
Group I174 Participants
Group I322 Participants
Group I151 Participants
Group I171 Participants
Group I51 Participants
Group I51 Participants
Group II63 Participants
Group II158 Participants
Group II320 Participants
Group II159 Participants
Group II144 Participants
Group II63 Participants
Group III137 Participants
Group III169 Participants
Group III168 Participants
Group III58 Participants
Group III58 Participants
Group III313 Participants
Group IV91 Participants
Group IV92 Participants
Group IV235 Participants
Group IV291 Participants
Group IV535 Participants
Group IV292 Participants
NCT01356602GoutPain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups
72 hours post dose
Canakinumab, Pre-filled Syringes (PFS)17.1 Millimeters (±2.04 Standard Error)
Triamcinolone Acetonide32 Millimeters (±2.08 Standard Error)
NCT01362608GoutThe Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)
at 72 hours post-dose
ACZ885 150 mg18.2 units on a scale (±3.03 Standard Error)
Triamcinolone Acetonide 40 mg37.9 units on a scale (±3.03 Standard Error)
NCT01362608GoutTime to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis
12 weeks
ACZ885 150 mg5 Participants (±3.03 95% Confidence Interval)
Triamcinolone Acetonide 40 mg17 Participants (±3.03 95% Confidence Interval)
NCT01431638GoutNumber of Participants Who Reported Adverse Events
From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Canakinumab, Lyophilizate (LYO)65 Participants
Canakinumab, Pre-filled Syringes (PFS)78 Participants
Triamcinolone Acetonide64 Participants
NCT02059291—Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks)
16 weeks
Epoch 2: crCMF: Placebo6.25 Percentage of participants
Epoch 2: crFMF: 150 mg61.29 Percentage of participants
Epoch 2: HIDS/MKD: 150 mg35.14 Percentage of participants
Epoch 2: HIDS/MKD: Placebo5.71 Percentage of participants
Epoch 2: TRAPS: 150 mg45.45 Percentage of participants
Epoch 2: TRAPS: Placebo8.33 Percentage of participants
NCT02296424
ß-SPECIFIC 4
Arthritis, JuvenileNumber of Participants in Clinical Remission on Canakinumab Who Are Able to Remain at an Initial Reduced Canakinumab Dose or Prolonged Canakinumab Dose Interval.
baseline to 24 weeks
Canakinumab Dose Interval Prolongation31 particiapants
Canakinumab Dose Interval Prolongation6 particiapants
Canakinumab Dose Reduction11 particiapants
Canakinumab Dose Reduction27 particiapants
NCT02334748Arthritis, JuvenileAll-cause Mortality
uo to 1 year
Canakinumab0 Participants
NCT02334748Arthritis, JuvenileNumber of Participants With Adverse Events
every 4 weeks up to 1 year
Canakinumab7 Participants
Canakinumab29 Participants
NCT02396212Arthritis, JuvenilePercentage of Participants Who Achieved a Minimum Adapted American College of Rheumatology (ACR) Pediatric 30 Criteria
Week 8
Canakinumab 4 mg/kg Every 4 Weeks100.0 Percentage of Participants
NCT02396212Arthritis, JuvenilePercentage of Participants With Canakinumab Treatment Who Were Able to Taper Corticosteroids Successfully
Week 28
Canakinumab 4 mg/kg Every 4 Weeks73.7 Percentage of Participants
NCT02911857—Number of Participants With Non-serious Adverse Events, Serious Adverse Events and Deaths
Participants were followed for the duration until approval, an expected average of 3 months.
cfFMF0 Participants
cfFMF0 Participants
cfFMF0 Participants
HIDS/MKD0 Participants
HIDS/MKD0 Participants
HIDS/MKD1 Participants
TRAPS0 Participants
TRAPS0 Participants
TRAPS1 Participants
NCT03447769
Canopy-A
Carcinoma, Non-Small-Cell LungDisease Free Survival (DFS) by Local Investigator
Up to approximately 4 years
Canakinumab35.02 Months
Placebo29.73 Months
NCT03626545
CANOPY-2
Carcinoma, Non-Small-Cell LungRandomized Part: Overall Survival (OS)
From randomization until death or final analysis data cutoff date (08-Jan-2021) whichever comes first (up to approximately (approx.) 18 months)
Randomized Part: Canakinumab + Docetaxel10.55 Months
Randomized Part: Placebo + Docetaxel11.30 Months
NCT03626545
CANOPY-2
Carcinoma, Non-Small-Cell LungSafety run-in Part: Percentage of Participants With Dose Limiting Toxicities (DLTs)
During the first 42 days of dosing
Safety run-in Part: Canakinumab+Docetaxel1 Participants
NCT03631199
CANOPY-1
Carcinoma, Non-Small-Cell LungPart 1 (Safety Run-in): Number of Participants With Dose-limiting Toxicities (DLTs)
During the first 42 days of dosing
Part 1: Cohort A0 Participants
Part 1: Cohort B0 Participants
Part 1: Cohort C1 Participants
NCT03631199
CANOPY-1
Carcinoma, Non-Small-Cell LungPart 2 (Double-blind, Randomized, Placebo-controlled): Overall Survival (OS) Per Investigator Assessment Using RECIST v1.1
Up to approximately 32 months
Part 2: Canakinumab+Pembro+CTx20.83 months
Part 2: Placebo+Pembro+CTx20.17 months
NCT03631199
CANOPY-1
Carcinoma, Non-Small-Cell LungPart 2 (Double-blind, Randomized, Placebo-controlled): Progression-free Survival (PFS) Per Investigator Assessment Using RECIST v1.1
18 months
Part 2: Canakinumab+Pembro+CTx6.77 months
Part 2: Placebo+Pembro+CTx6.77 months
NCT04362813
CAN-COVID
COVID-19Participants Who Survived Without Requiring Invasive Mechanical Ventilation From Day 3 to Day 29, Primary Analysis
Day 3 to Day 29
Canakinumab198 Participants
Placebo191 Participants
NCT04717635Still's Disease, Adult-OnsetPercentage of Participants Who Achieved Adapted American College of Rheumatology (ACR) 30 Response at Week 8
Baseline, Week 8
Canakinumab50.0 Percentage of participants

Publications by year

1996–2026: 90 publications.

1996
1
1998
1
2001
1
2004
1
2005
2
2006
2
2007
3
2008
6
2009
4
2010
4
2011
2
2012
5
2013
5
2014
3
2015
2
2016
6
2017
3
2018
3
2019
8
2020
4
2021
8
2022
7
2024
7
2025
1
2026
1

Publications by indication

Atherosclerosis (19)

  • Covariate Adjustment for the Win Odds: Application to Cardiovascular Outcomes Trials.
    Stat Med · 2026 · PMID 42141513 · NCT01327846
  • Effects of IL-1β inhibition on anemia and clonal hematopoiesis in the randomized CANTOS trial.
    Blood Adv · 2024 · PMID 37934948 · NCT01327846
  • TET2-Driven Clonal Hematopoiesis and Response to Canakinumab: An Exploratory Analysis of the CANTOS Randomized Clinical Trial.
    JAMA Cardiol · 2022 · PMID 35385050 · NCT01327846
  • Inflammation drives residual risk in chronic kidney disease: a CANTOS substudy.
    Eur Heart J · 2022 · PMID 35943897 · NCT01327846
  • Residual inflammatory risk associated with interleukin-18 and interleukin-6 after successful interleukin-1β inhibition with canakinumab: further rationale for the development of targeted anti-cytokine therapies for the treatment of atherothrombosis.
    Eur Heart J · 2021 · PMID 31504417 · NCT01327846

Schnitzler Syndrome (9)

  • Sustained efficacy of the monoclonal anti-interleukin-1 beta antibody canakinumab in a 9-month trial in Schnitzler's syndrome.
    Ann Rheum Dis · 2013 · PMID 23087179 · NCT01276522
  • Schnitzler syndrome: response to anakinra in two cases and a review of the literature.
    Int J Dermatol · 2010 · PMID 20064173 · NCT01276522
  • In vivo regulation of interleukin 1beta in patients with cryopyrin-associated periodic syndromes.
    J Exp Med · 2009 · PMID 19364880 · NCT01276522
  • Use of canakinumab in the cryopyrin-associated periodic syndrome.
    N Engl J Med · 2009 · PMID 19494217 · NCT01276522
  • IL-1 blockade in Schnitzler syndrome: ex vivo findings correlate with clinical remission.
    J Allergy Clin Immunol · 2008 · PMID 17936890 · NCT01276522

Cryopyrin-Associated Periodic Syndromes (7)

  • A 24-month open-label study of canakinumab in neonatal-onset multisystem inflammatory disease.
    Ann Rheum Dis · 2015 · PMID 24906637 · NCT00770601
  • Safety and efficacy of canakinumab in Japanese patients with phenotypes of cryopyrin-associated periodic syndrome as established in the first open-label, phase-3 pivotal study (24-week results).
    Clin Exp Rheumatol · 2013 · PMID 23380020 · NCT00991146
  • Canakinumab (ACZ885, a fully human IgG1 anti-IL-1β mAb) induces sustained remission in pediatric patients with cryopyrin-associated periodic syndrome (CAPS).
    Arthritis Res Ther · 2012 · PMID 21356079 · NCT00487708
  • Two-year results from an open-label, multicentre, phase III study evaluating the safety and efficacy of canakinumab in patients with cryopyrin-associated periodic syndrome across different severity phenotypes.
    Ann Rheum Dis · 2012 · PMID 21859692 · NCT00685373
  • Neonatal-onset multisystem inflammatory disease responsive to interleukin-1beta inhibition.
    N Engl J Med · 2006 · PMID 16899778 · NCT00770601

Arthritis, Juvenile (6)

  • Tapering Canakinumab Monotherapy in Patients With Systemic Juvenile Idiopathic Arthritis in Clinical Remission: Results From a Phase IIIb/IV Open-Label, Randomized Study.
    Arthritis Rheumatol · 2021 · PMID 32783351 · NCT02296424
  • Efficacy and safety of canakinumab in systemic juvenile idiopathic arthritis: 48-week results from an open-label phase III study in Japanese patients.
    Mod Rheumatol · 2021 · PMID 32552266 · NCT02396212
  • Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials.
    Ann Rheum Dis · 2019 · PMID 30269054 · NCT00891046
  • Early changes in gene expression and inflammatory proteins in systemic juvenile idiopathic arthritis patients on canakinumab therapy.
    Arthritis Res Ther · 2017 · PMID 28115015 · NCT00886769
  • Rate and Clinical Presentation of Macrophage Activation Syndrome in Patients With Systemic Juvenile Idiopathic Arthritis Treated With Canakinumab.
    Arthritis Rheumatol · 2016 · PMID 26314396 · NCT00891046

Carcinoma, Non-Small-Cell Lung (5)

  • Canakinumab Versus Placebo in Combination With First-Line Pembrolizumab Plus Chemotherapy for Advanced Non-Small-Cell Lung Cancer: Results From the CANOPY-1 Trial.
    J Clin Oncol · 2024 · PMID 38039427 · NCT03631199
  • Spartalizumab in combination with platinum-doublet chemotherapy with or without canakinumab in patients with PD-L1-unselected, metastatic NSCLC.
    BMC Cancer · 2024 · PMID 39448966 · NCT03064854
  • Canakinumab in combination with docetaxel compared with docetaxel alone for the treatment of advanced non-small cell lung cancer following platinum-based doublet chemotherapy and immunotherapy (CANOPY-2): A multicenter, randomized, double-blind, phase 3 trial.
    Lung Cancer · 2024 · PMID 38354535 · NCT03626545
  • Canakinumab as Adjuvant Therapy in Patients With Completely Resected Non-Small-Cell Lung Cancer: Results From the CANOPY-A Double-Blind, Randomized Clinical Trial.
    J Clin Oncol · 2024 · PMID 37788412 · NCT03447769
  • Canakinumab with and without pembrolizumab in patients with resectable non-small-cell lung cancer: CANOPY-N study design.
    Future Oncol · 2021 · PMID 33648347 · NCT03968419

Gout (3)

  • Pharmacokinetic and pharmacodynamic properties of canakinumab in patients with gouty arthritis.
    J Clin Pharmacol · 2014 · PMID 24122883 · NCT01080131
  • Canakinumab relieves symptoms of acute flares and improves health-related quality of life in patients with difficult-to-treat Gouty Arthritis by suppressing inflammation: results of a randomized, dose-ranging study.
    Arthritis Res Ther · 2012 · PMID 21439048 · NCT00798369
  • Canakinumab for the treatment of acute flares in difficult-to-treat gouty arthritis: Results of a multicenter, phase II, dose-ranging study.
    Arthritis Rheum · 2010 · PMID 20533546 · NCT00798369

Publications by journal

Trial-results highlights

For Cryopyrin-Associated Periodic Syndromes (CAPS), a study (NCT00770601) evaluating the percentage of participants with complete remission and relapse after 6 months of canakinumab treatment reported 0% of participants. In another study (NCT00685373) over 2 years, the canakinumab arm reported:

  • 150 participants with Adverse Events (AEs)
  • 18 participants with Serious Adverse Events (SAEs)
  • 109 participants with Infections and Infestations
  • 4 participants with Injection Site Reactions
  • 2 participants with discontinuation of study drug due to an AE
  • 0 participants with death

For Juvenile Arthritis, the β-SPECIFIC 1 study (NCT00886769) assessed the percentage of patients meeting the adapted American College of Rheumatology (ACR) Pediatric 30 Criteria. On Day 15, canakinumab showed 79.1% of participants met the criteria, compared to 9.8% in the placebo arm. By Day 29, canakinumab showed 83.7% of participants met the criteria, versus 9.8% in the placebo arm. In the β-SPECIFIC 2 study (NCT00889863), Part I found that 44.5% of participants in the canakinumab arm were able to taper steroids as per protocol over 32 weeks. Part II of the same study reported a median time to flare of 236.0 days for the placebo arm, while the median for the canakinumab arm was not available.

The β-SPECIFIC 3 study (NCT00891046) reported on safety outcomes for Juvenile Arthritis. Among ACZ885 treated participants, 137 participants experienced Adverse Events (AEs), 47 participants experienced Serious Adverse Events (SAEs), and 14 participants had AEs leading to discontinuation. 57 participants experienced treatment-related AEs, and 4 participants had SAEs leading to discontinuation. The study also found 0 participants in both the ACZ885 treated and ACZ885 treatment naive groups developed anti-ACZ885 antibodies. Regarding clinically significant local injection site reactions, the ACZ885 treated arm reported 15 participants, 3 participants, 129 participants, and 0 participants across different assessments, while the ACZ885 treatment naive arm reported 6 participants and 115 participants. All values are sourced from primary registry reporting, and individual papers should be consulted for clinical decisions.

All Canakinumab publications (90)

2026 (1 paper)

  1. Covariate Adjustment for the Win Odds: Application to Cardiovascular Outcomes Trials.
    Scheidegger C, Wandel S, Mütze T, et al. · Stat Med · 2026 · Derived
    PubMed: PMID 42141513 · NCT01327846 (CANTOS) · Atherosclerosis

2025 (1 paper)

  1. IL-1 Signal Inhibition in Alcohol-Related Hepatitis: A Randomized, Double-Blind, Placebo-Controlled Trial of Canakinumab.
    Vergis N, Patel V, Bogdanowicz K, et al. · Clin Gastroenterol Hepatol · 2025 · Derived
    PubMed: PMID 39181422 · NCT03775109 (ISAIAH) · Alcoholism

2024 (7 papers)

  1. Effects of IL-1β inhibition on anemia and clonal hematopoiesis in the randomized CANTOS trial.
    Woo J, Lu D, Lewandowski A, et al. · Blood Adv · 2024 · Derived
    PubMed: PMID 37934948 · NCT01327846 (CANTOS) · Atherosclerosis
  2. Canakinumab Versus Placebo in Combination With First-Line Pembrolizumab Plus Chemotherapy for Advanced Non-Small-Cell Lung Cancer: Results From the CANOPY-1 Trial.
    Tan DSW, Felip E, de Castro G, et al. · J Clin Oncol · 2024 · Derived
    PubMed: PMID 38039427 · NCT03631199 (CANOPY-1) · Carcinoma, Non-Small-Cell Lung
  3. Spartalizumab in combination with platinum-doublet chemotherapy with or without canakinumab in patients with PD-L1-unselected, metastatic NSCLC.
    Santoro A, Pilar G, Tan DSW, et al. · BMC Cancer · 2024 · Derived
    PubMed: PMID 39448966 · NCT03064854 · Carcinoma, Non-Small-Cell Lung
  4. The IL-1β inhibitor canakinumab in previously treated lower-risk myelodysplastic syndromes: a phase 2 clinical trial.
    Rodriguez-Sevilla JJ, Adema V, Chien KS, et al. · Nat Commun · 2024 · Derived
    PubMed: PMID 39537648 · NCT04239157 · Myelodysplastic Syndromes
  5. Canakinumab in combination with docetaxel compared with docetaxel alone for the treatment of advanced non-small cell lung cancer following platinum-based doublet chemotherapy and immunotherapy (CANOPY-2): A multicenter, randomized, double-blind, phase 3 trial.
    Paz-Ares L, Goto Y, Wan-Teck Lim D, et al. · Lung Cancer · 2024 · Derived
    PubMed: PMID 38354535 · NCT03626545 (CANOPY-2) · Carcinoma, Non-Small-Cell Lung
  6. Long-Term Efficacy and Safety of Canakinumab in Patients With Tumor Necrosis Factor Receptor-Associated Periodic Syndrome: Results From a Phase III Trial.
    Gattorno M, Obici L, Penadés IC, et al. · Arthritis Rheumatol · 2024 · Derived
    PubMed: PMID 37668289 · NCT02059291
  7. Canakinumab as Adjuvant Therapy in Patients With Completely Resected Non-Small-Cell Lung Cancer: Results From the CANOPY-A Double-Blind, Randomized Clinical Trial.
    Garon EB, Lu S, Goto Y, et al. · J Clin Oncol · 2024 · Derived
    PubMed: PMID 37788412 · NCT03447769 (Canopy-A) · Carcinoma, Non-Small-Cell Lung

2022 (7 papers)

  1. TET2-Driven Clonal Hematopoiesis and Response to Canakinumab: An Exploratory Analysis of the CANTOS Randomized Clinical Trial.
    Svensson EC, Madar A, Campbell CD, et al. · JAMA Cardiol · 2022 · Derived
    PubMed: PMID 35385050 · NCT01327846 (CANTOS) · Atherosclerosis
  2. Clinical trial enrollment at a rural satellite hospital during COVID-19 pandemic.
    Sedhai YR, Sears M, Vecchiè A, et al. · J Clin Transl Sci · 2022 · Derived
    PubMed: PMID 34367680 · NCT04362813 (CAN-COVID) · COVID-19
  3. Inflammation drives residual risk in chronic kidney disease: a CANTOS substudy.
    Ridker PM, Tuttle KR, Perkovic V, et al. · Eur Heart J · 2022 · Derived
    PubMed: PMID 35943897 · NCT01327846 (CANTOS) · Atherosclerosis
  4. CCN2 Binds to Tubular Epithelial Cells in the Kidney.
    Rayego-Mateos S, Morgado-Pascual JL, Lavoz C, et al. · Biomolecules · 2022 · Derived
    PubMed: PMID 35204752 · NCT04229004 · Pancreatic Neoplasms
  5. Cardiovascular disease risk in women living with HIV.
    Kentoffio K, Temu TM, Shakil SS, et al. · Curr Opin HIV AIDS · 2022 · Derived
    PubMed: PMID 35938460 · NCT02272946 · Cardiovascular Diseases
  6. Long-term efficacy and safety of canakinumab in patients with mevalonate kinase deficiency: results from the randomised Phase 3 CLUSTER trial.
    Jeyaratnam J, Simon A, Calvo I, et al. · Rheumatology (Oxford) · 2022 · Derived
    PubMed: PMID 34554243 · NCT02059291
  7. Canakinumab in patients with COVID-19 and type 2 diabetes - A multicentre, randomised, double-blind, placebo-controlled trial.
    Hepprich M, Mudry JM, Gregoriano C, et al. · EClinicalMedicine · 2022 · Derived
    PubMed: PMID 36128334 · NCT04510493 (CanCovDia) · COVID-19

2021 (8 papers)

  1. IL-1 Signal Inhibition In Alcoholic Hepatitis (ISAIAH): a study protocol for a multicentre, randomised, placebo-controlled trial to explore the potential benefits of canakinumab in the treatment of alcoholic hepatitis.
    Vergis N, Patel V, Bogdanowicz K, et al. · Trials · 2021 · Trial result
    PubMed: PMID 34763711 · NCT03775109 (ISAIAH) · Alcoholism
  2. Residual inflammatory risk associated with interleukin-18 and interleukin-6 after successful interleukin-1β inhibition with canakinumab: further rationale for the development of targeted anti-cytokine therapies for the treatment of atherothrombosis.
    Ridker PM, MacFadyen JG, Thuren T, et al. · Eur Heart J · 2021 · Derived
    PubMed: PMID 31504417 · NCT01327846 (CANTOS) · Atherosclerosis
  3. Tapering Canakinumab Monotherapy in Patients With Systemic Juvenile Idiopathic Arthritis in Clinical Remission: Results From a Phase IIIb/IV Open-Label, Randomized Study.
    Quartier P, Alexeeva E, Constantin T, et al. · Arthritis Rheumatol · 2021 · Derived
    PubMed: PMID 32783351 · NCT02296424 (ß-SPECIFIC 4) · Arthritis, Juvenile
  4. Efficacy and safety of canakinumab in systemic juvenile idiopathic arthritis: 48-week results from an open-label phase III study in Japanese patients.
    Nishimura K, Hara R, Umebayashi H, et al. · Mod Rheumatol · 2021 · Derived
    PubMed: PMID 32552266 · NCT02396212 · Arthritis, Juvenile
  5. Canakinumab Lacks Efficacy in Treating Adult Patients with Moderate to Severe Chronic Spontaneous Urticaria in a Phase II Randomized Double-Blind Placebo-Controlled Single-Center Study.
    Maul JT, Distler M, Kolios A, et al. · J Allergy Clin Immunol Pract · 2021 · Derived
    PubMed: PMID 32827729 · NCT01635127 (URTICANA) · Chronic Urticaria
  6. Canakinumab with and without pembrolizumab in patients with resectable non-small-cell lung cancer: CANOPY-N study design.
    Garrido P, Pujol JL, Kim ES, et al. · Future Oncol · 2021 · Derived
    PubMed: PMID 33648347 · NCT03968419 (CANOPY-N) · Carcinoma, Non-Small-Cell Lung
  7. Inhibition of Interleukin-1β and Reduction in Atherothrombotic Cardiovascular Events in the CANTOS Trial.
    Everett BM, MacFadyen JG, Thuren T, et al. · J Am Coll Cardiol · 2021 · Derived
    PubMed: PMID 33004131 · NCT01327846 (CANTOS) · Atherosclerosis
  8. Effect of Canakinumab vs Placebo on Survival Without Invasive Mechanical Ventilation in Patients Hospitalized With Severe COVID-19: A Randomized Clinical Trial.
    Caricchio R, Abbate A, Gordeev I, et al. · JAMA · 2021 · Derived
    PubMed: PMID 34283183 · NCT04362813 (CAN-COVID) · COVID-19

2020 (4 papers)

  1. Effects of Interleukin-1β Inhibition on Incident Anemia: Exploratory Analyses From a Randomized Trial.
    Vallurupalli M, MacFadyen JG, Glynn RJ, et al. · Ann Intern Med · 2020 · Derived
    PubMed: PMID 32203978 · NCT01327846 (CANTOS) · Atherosclerosis
  2. Effects of Interleukin-1β Inhibition on Incident Hip and Knee Replacement : Exploratory Analyses From a Randomized, Double-Blind, Placebo-Controlled Trial.
    Schieker M, Conaghan PG, Mindeholm L, et al. · Ann Intern Med · 2020 · Derived
    PubMed: PMID 32744862 · NCT01327846 (CANTOS) · Atherosclerosis
  3. Effects of Interleukin-1β Inhibition on Blood Pressure, Incident Hypertension, and Residual Inflammatory Risk: A Secondary Analysis of CANTOS.
    Rothman AM, MacFadyen J, Thuren T, et al. · Hypertension · 2020 · Derived
    PubMed: PMID 31884854 · NCT01327846 (CANTOS) · Atherosclerosis
  4. Tumor Cell-Derived IL1β Promotes Desmoplasia and Immune Suppression in Pancreatic Cancer.
    Das S, Shapiro B, Vucic EA, et al. · Cancer Res · 2020 · Background
    PubMed: PMID 31915130 · NCT04581343 (PanCAN-SR1)

2019 (8 papers)

  1. Relationship of Interleukin-1β Blockade With Incident Gout and Serum Uric Acid Levels: Exploratory Analysis of a Randomized Controlled Trial.
    Solomon DH, Glynn RJ, MacFadyen JG, et al. · Ann Intern Med · 2019 · Derived
    PubMed: PMID 30242335 · NCT01327846 (CANTOS) · Atherosclerosis
  2. A randomized, placebo-controlled trial of canakinumab in patients with peripheral artery disease.
    Russell KS, Yates DP, Kramer CM, et al. · Vasc Med · 2019 · Derived
    PubMed: PMID 31277561 · NCT01731990 · Intermittent Claudication
  3. Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials.
    Ruperto N, Brunner HI, Quartier P, et al. · Ann Rheum Dis · 2019 · Derived
    PubMed: PMID 30269054 · NCT00891046 (β-SPECIFIC 3) · Arthritis, Juvenile
  4. Inhibition of Interleukin-1β by Canakinumab and Cardiovascular Outcomes in Patients With Chronic Kidney Disease.
    Ridker PM, MacFadyen JG, Glynn RJ, et al. · J Am Coll Cardiol · 2019 · Derived
    PubMed: PMID 29793629 · NCT01327846 (CANTOS) · Atherosclerosis
  5. Modulation of the interleukin-6 signalling pathway and incidence rates of atherosclerotic events and all-cause mortality: analyses from the Canakinumab Anti-Inflammatory Thrombosis Outcomes Study (CANTOS).
    Ridker PM, Libby P, MacFadyen JG, et al. · Eur Heart J · 2019 · Derived
    PubMed: PMID 30165610 · NCT01327846 (CANTOS) · Atherosclerosis
  6. Anti-Inflammatory Therapy With Canakinumab for the Prevention and Management of Diabetes.
    Everett BM, Donath MY, Pradhan AD, et al. · J Am Coll Cardiol · 2019 · Derived
    PubMed: PMID 29544870 · NCT01327846 (CANTOS) · Atherosclerosis
  7. Anti-Inflammatory Therapy With Canakinumab for the Prevention of Hospitalization for Heart Failure.
    Everett BM, Cornel JH, Lainscak M, et al. · Circulation · 2019 · Derived
    PubMed: PMID 30586730 · NCT01327846 (CANTOS) · Atherosclerosis
  8. Blocking IL-1β reverses the immunosuppression in mouse breast cancer and synergizes with anti-PD-1 for tumor abrogation.
    Kaplanov I, Carmi Y, Kornetsky R, et al. · Proc Natl Acad Sci U S A · 2019 · Background
    PubMed: PMID 30545915 · NCT04581343 (PanCAN-SR1)

2018 (3 papers)

  1. Effect of interleukin-1β inhibition with canakinumab on incident lung cancer in patients with atherosclerosis: exploratory results from a randomised, double-blind, placebo-controlled trial.
    Ridker PM, MacFadyen JG, Thuren T, et al. · Lancet · 2018 · Derived
    PubMed: PMID 28855077 · NCT01327846 (CANTOS) · Atherosclerosis
  2. Relationship of C-reactive protein reduction to cardiovascular event reduction following treatment with canakinumab: a secondary analysis from the CANTOS randomised controlled trial.
    Ridker PM, MacFadyen JG, Everett BM, et al. · Lancet · 2018 · Derived
    PubMed: PMID 29146124 · NCT01327846 (CANTOS) · Atherosclerosis
  3. Canakinumab for the Treatment of Autoinflammatory Recurrent Fever Syndromes.
    De Benedetti F, Gattorno M, Anton J, et al. · N Engl J Med · 2018 · Derived
    PubMed: PMID 29768139 · NCT02059291

2017 (3 papers)

  1. Antiinflammatory Therapy with Canakinumab for Atherosclerotic Disease.
    Ridker PM, Everett BM, Thuren T, et al. · N Engl J Med · 2017 · Derived
    PubMed: PMID 28845751 · NCT01327846 (CANTOS) · Atherosclerosis
  2. Early changes in gene expression and inflammatory proteins in systemic juvenile idiopathic arthritis patients on canakinumab therapy.
    Brachat AH, Grom AA, Wulffraat N, et al. · Arthritis Res Ther · 2017 · Derived
    PubMed: PMID 28115015 · NCT00886769 (β-SPECIFIC 1) · Arthritis, Juvenile
  3. Open-Label, Phase II Study to Assess the Efficacy and Safety of Canakinumab Treatment in Active Hyperimmunoglobulinemia D With Periodic Fever Syndrome.
    Arostegui JI, Anton J, Calvo I, et al. · Arthritis Rheumatol · 2017 · Derived
    PubMed: PMID 28482144 · NCT01303380 · Mevalonate Kinase Deficiency

2016 (6 papers)

  1. Pharmacokinetic and pharmacodynamic characteristics of single-dose Canakinumab in patients with type 2 diabetes mellitus.
    Noe A, Howard C, Thuren T, et al. · Clin Ther · 2016 · Derived
    PubMed: PMID 25240532 · NCT00900146 · Diabetes Mellitus, Type 2
  2. Gene-expression analysis of adult-onset Still's disease and systemic juvenile idiopathic arthritis is consistent with a continuum of a single disease entity.
    Nirmala N, Brachat A, Feist E, et al. · Pediatr Rheumatol Online J · 2016 · Derived
    PubMed: PMID 26589963 · NCT02204293 (CONSIDER)
  3. Efficacy and safety of canakinumab in adolescents and adults with colchicine-resistant familial Mediterranean fever.
    Gül A, Ozdogan H, Erer B, et al. · Arthritis Res Ther · 2016 · Derived
    PubMed: PMID 26337145 · NCT01088880 · Familial Mediterranean Fever
  4. Rate and Clinical Presentation of Macrophage Activation Syndrome in Patients With Systemic Juvenile Idiopathic Arthritis Treated With Canakinumab.
    Grom AA, Ilowite NT, Pascual V, et al. · Arthritis Rheumatol · 2016 · Derived
    PubMed: PMID 26314396 · NCT00891046 (β-SPECIFIC 3) · Arthritis, Juvenile
  5. Usefulness of C-Reactive Protein Plasma Levels to Predict Exercise Intolerance in Patients With Chronic Systolic Heart Failure.
    Canada JM, Fronk DT, Cei LF, et al. · Am J Cardiol · 2016 · Derived
    PubMed: PMID 26546248 · NCT01327846 (CANTOS) · Atherosclerosis
  6. Robust exchangeability designs for early phase clinical trials with multiple strata.
    Neuenschwander B, Wandel S, Roychoudhury S, et al. · Pharm Stat · 2016 · Background
    PubMed: PMID 26685103 · NCT04581343 (PanCAN-SR1)

2015 (2 papers)

  1. Canakinumab for the treatment of children with colchicine-resistant familial Mediterranean fever: a 6-month open-label, single-arm pilot study.
    Brik R, Butbul-Aviel Y, Lubin S, et al. · Arthritis Rheumatol · 2015 · Trial result
    PubMed: PMID 25049046 · NCT01148797 (CONTROL FMF)
  2. A 24-month open-label study of canakinumab in neonatal-onset multisystem inflammatory disease.
    Sibley CH, Chioato A, Felix S, et al. · Ann Rheum Dis · 2015 · Derived
    PubMed: PMID 24906637 · NCT00770601 · Cryopyrin-Associated Periodic Syndromes

2014 (3 papers)

  1. Impact of interleukin-1β antibody (canakinumab) on glycaemic indicators in patients with type 2 diabetes mellitus: results of secondary endpoints from a randomized, placebo-controlled trial.
    Hensen J, Howard CP, Walter V, et al. · Diabetes Metab · 2014 · Derived
    PubMed: PMID 24075453 · NCT00900146 · Diabetes Mellitus, Type 2
  2. Pharmacokinetic and pharmacodynamic properties of canakinumab in patients with gouty arthritis.
    Chakraborty A, Van LM, Skerjanec A, et al. · J Clin Pharmacol · 2014 · Derived
    PubMed: PMID 24122883 · NCT01080131 (β-RELIEVED-II) · Gout
  3. The current state of Bayesian methods in medical product development: survey results and recommendations from the DIA Bayesian Scientific Working Group.
    Natanegara F, Neuenschwander B, Seaman JW, et al. · Pharm Stat · 2014 · Background
    PubMed: PMID 24027093 · NCT04581343 (PanCAN-SR1)

2013 (5 papers)

  1. Interleukin-1 antagonism in type 1 diabetes of recent onset: two multicentre, randomised, double-blind, placebo-controlled trials.
    Moran A, Bundy B, Becker DJ, et al. · Lancet · 2013 · Trial result
    PubMed: PMID 23562090 · NCT00947427 (TN14) · Diabetes Mellitus, Type 1
  2. Safety and efficacy of canakinumab in Japanese patients with phenotypes of cryopyrin-associated periodic syndrome as established in the first open-label, phase-3 pivotal study (24-week results).
    Imagawa T, Nishikomori R, Takada H, et al. · Clin Exp Rheumatol · 2013 · Trial result
    PubMed: PMID 23380020 · NCT00991146 · Cryopyrin-Associated Periodic Syndromes
  3. Two randomized trials of canakinumab in systemic juvenile idiopathic arthritis.
    Ruperto N, Brunner HI, Quartier P, et al. · N Engl J Med · 2013 · Derived
    PubMed: PMID 23252526 · NCT00889863 (β-SPECIFIC 2) · Arthritis, Juvenile
  4. Effects of interleukin-1β inhibition with canakinumab on hemoglobin A1c, lipids, C-reactive protein, interleukin-6, and fibrinogen: a phase IIb randomized, placebo-controlled trial.
    Ridker PM, Howard CP, Walter V, et al. · Circulation · 2013 · Derived
    PubMed: PMID 23129601 · NCT00900146 · Diabetes Mellitus, Type 2
  5. Sustained efficacy of the monoclonal anti-interleukin-1 beta antibody canakinumab in a 9-month trial in Schnitzler's syndrome.
    de Koning HD, Schalkwijk J, van der Ven-Jongekrijg J, et al. · Ann Rheum Dis · 2013 · Derived
    PubMed: PMID 23087179 · NCT01276522 · Schnitzler Syndrome

2012 (5 papers)

  1. Canakinumab relieves symptoms of acute flares and improves health-related quality of life in patients with difficult-to-treat Gouty Arthritis by suppressing inflammation: results of a randomized, dose-ranging study.
    Schlesinger N, De Meulemeester M, Pikhlak A, et al. · Arthritis Res Ther · 2012 · Derived
    PubMed: PMID 21439048 · NCT00798369 · Gout
  2. Canakinumab (ACZ885, a fully human IgG1 anti-IL-1β mAb) induces sustained remission in pediatric patients with cryopyrin-associated periodic syndrome (CAPS).
    Kuemmerle-Deschner JB, Ramos E, Blank N, et al. · Arthritis Res Ther · 2012 · Derived
    PubMed: PMID 21356079 · NCT00487708 · Cryopyrin-Associated Periodic Syndromes
  3. Two-year results from an open-label, multicentre, phase III study evaluating the safety and efficacy of canakinumab in patients with cryopyrin-associated periodic syndrome across different severity phenotypes.
    Kuemmerle-Deschner JB, Hachulla E, Cartwright R, et al. · Ann Rheum Dis · 2012 · Derived
    PubMed: PMID 21859692 · NCT00685373 · Cryopyrin-Associated Periodic Syndromes
  4. Efficacy and safety of the human anti-IL-1β monoclonal antibody canakinumab in rheumatoid arthritis: results of a 12-week, Phase II, dose-finding study.
    Alten R, Gomez-Reino J, Durez P, et al. · BMC Musculoskelet Disord · 2012 · Derived
    PubMed: PMID 21736751 · NCT00424346 · Arthritis, Rheumatoid
  5. Gemcitabine plus nab-paclitaxel is an active regimen in patients with advanced pancreatic cancer: a phase I/II trial.
    Von Hoff DD, Ramanathan RK, Borad MJ, et al. · J Clin Oncol · 2012 · Background
    PubMed: PMID 21969517 · NCT04581343 (PanCAN-SR1)

2011 (2 papers)

  1. Canakinumab reduces the risk of acute gouty arthritis flares during initiation of allopurinol treatment: results of a double-blind, randomised study.
    Schlesinger N, Mysler E, Lin HY, et al. · Ann Rheum Dis · 2011 · Trial result
    PubMed: PMID 21540198 · NCT00927810 · Arthritis, Gouty
  2. Interleukin-1β inhibition and the prevention of recurrent cardiovascular events: rationale and design of the Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS).
    Ridker PM, Thuren T, Zalewski A, et al. · Am Heart J · 2011 · Derived
    PubMed: PMID 21982649 · NCT01327846 (CANTOS) · Atherosclerosis

2010 (4 papers)

  1. Canakinumab for the treatment of acute flares in difficult-to-treat gouty arthritis: Results of a multicenter, phase II, dose-ranging study.
    So A, De Meulemeester M, Pikhlak A, et al. · Arthritis Rheum · 2010 · Derived
    PubMed: PMID 20533546 · NCT00798369 · Gout
  2. Unresponsiveness to colchicine therapy in patients with familial Mediterranean fever homozygous for the M694V mutation.
    Soylemezoglu O, Arga M, Fidan K, et al. · J Rheumatol · 2010 · Background
    PubMed: PMID 20008920 · NCT01148797 (CONTROL FMF)
  3. Schnitzler syndrome: response to anakinra in two cases and a review of the literature.
    Schuster C, Kränke B, Aberer E, et al. · Int J Dermatol · 2010 · Background
    PubMed: PMID 20064173 · NCT01276522 · Schnitzler Syndrome
  4. Summarizing historical information on controls in clinical trials.
    Neuenschwander B, Capkun-Niggli G, Branson M, et al. · Clin Trials · 2010 · Background
    PubMed: PMID 20156954 · NCT04581343 (PanCAN-SR1)

2009 (4 papers)

  1. Successful treatment of familial Mediterranean fever with Anakinra and outcome after renal transplantation.
    Moser C, Pohl G, Haslinger I, et al. · Nephrol Dial Transplant · 2009 · Background
    PubMed: PMID 19033248 · NCT01148797 (CONTROL FMF)
  2. Horror autoinflammaticus: the molecular pathophysiology of autoinflammatory disease (*).
    Masters SL, Simon A, Aksentijevich I, et al. · Annu Rev Immunol · 2009 · Background
    PubMed: PMID 19302049 · NCT01148797 (CONTROL FMF)
  3. In vivo regulation of interleukin 1beta in patients with cryopyrin-associated periodic syndromes.
    Lachmann HJ, Lowe P, Felix SD, et al. · J Exp Med · 2009 · Background
    PubMed: PMID 19364880 · NCT01276522 · Schnitzler Syndrome
  4. Use of canakinumab in the cryopyrin-associated periodic syndrome.
    Lachmann HJ, Kone-Paut I, Kuemmerle-Deschner JB, et al. · N Engl J Med · 2009 · Background
    PubMed: PMID 19494217 · NCT01276522 · Schnitzler Syndrome

2008 (6 papers)

  1. IL-1 blockade in Schnitzler syndrome: ex vivo findings correlate with clinical remission.
    Ryan JG, de Koning HD, Beck LA, et al. · J Allergy Clin Immunol · 2008 · Background
    PubMed: PMID 17936890 · NCT01276522 · Schnitzler Syndrome
  2. Anakinra: new therapeutic approach in children with Familial Mediterranean Fever resistant to colchicine.
    Roldan R, Ruiz AM, Miranda MD, et al. · Joint Bone Spine · 2008 · Background
    PubMed: PMID 18541452 · NCT01148797 (CONTROL FMF)
  3. Critical aspects of the Bayesian approach to phase I cancer trials.
    Neuenschwander B, Branson M, Gsponer T, et al. · Stat Med · 2008 · Background
    PubMed: PMID 18344187 · NCT04581343 (PanCAN-SR1)
  4. QuantiFERON-TB Gold assay for the diagnosis of latent tuberculosis infection.
    Manuel O, Kumar D · Expert Rev Mol Diagn · 2008 · Background
    PubMed: PMID 18598104 · NCT01148797 (CONTROL FMF)
  5. Familial Mediterranean fever: clinical, molecular and management advancements.
    Lidar M, Livneh A · Neth J Med · 2008 · Background
    PubMed: PMID 17954950 · NCT01148797 (CONTROL FMF)
  6. Schnitzler syndrome: beyond the case reports: review and follow-up of 94 patients with an emphasis on prognosis and treatment.
    de Koning HD, Bodar EJ, van der Meer JW, et al. · Semin Arthritis Rheum · 2008 · Background
    PubMed: PMID 17586002 · NCT01276522 · Schnitzler Syndrome

2007 (3 papers)

  1. Clinical significance and therapeutic potential of the programmed death-1 ligand/programmed death-1 pathway in human pancreatic cancer.
    Nomi T, Sho M, Akahori T, et al. · Clin Cancer Res · 2007 · Background
    PubMed: PMID 17404099 · NCT04581343 (PanCAN-SR1)
  2. Effective treatment of a colchicine-resistant familial Mediterranean fever patient with anakinra.
    Kuijk LM, Govers AM, Frenkel J, et al. · Ann Rheum Dis · 2007 · Background
    PubMed: PMID 17934085 · NCT01148797 (CONTROL FMF)
  3. Genetics and new treatment modalities for familial Mediterranean fever.
    Bhat A, Naguwa SM, Gershwin ME, et al. · Ann N Y Acad Sci · 2007 · Background
    PubMed: PMID 17911435 · NCT01148797 (CONTROL FMF)

2006 (2 papers)

  1. Neonatal-onset multisystem inflammatory disease responsive to interleukin-1beta inhibition.
    Goldbach-Mansky R, Dailey NJ, Canna SW, et al. · N Engl J Med · 2006 · Background
    PubMed: PMID 16899778 · NCT00770601 · Cryopyrin-Associated Periodic Syndromes
  2. Beneficial response to anakinra and thalidomide in Schnitzler's syndrome.
    de Koning HD, Bodar EJ, Simon A, et al. · Ann Rheum Dis · 2006 · Background
    PubMed: PMID 16096327 · NCT01276522 · Schnitzler Syndrome

2005 (2 papers)

  1. Evaluation of disease severity in familial Mediterranean fever.
    Mor A, Shinar Y, Zaks N, et al. · Semin Arthritis Rheum · 2005 · Background
    PubMed: PMID 16084225 · NCT01148797 (CONTROL FMF)
  2. Successful treatment of refractory Schnitzler syndrome with anakinra: comment on the article by Hawkins et al.
    Martinez-Taboada VM, Fontalba A, Blanco R, et al. · Arthritis Rheum · 2005 · Background
    PubMed: PMID 15986356 · NCT01276522 · Schnitzler Syndrome

2004 (1 paper)

  1. Spectrum of clinical features in Muckle-Wells syndrome and response to anakinra.
    Hawkins PN, Lachmann HJ, Aganna E, et al. · Arthritis Rheum · 2004 · Background
    PubMed: PMID 14872505 · NCT00770601 · Cryopyrin-Associated Periodic Syndromes

2001 (1 paper)

  1. The Schnitzler syndrome. Four new cases and review of the literature.
    Lipsker D, Veran Y, Grunenberger F, et al. · Medicine (Baltimore) · 2001 · Background
    PubMed: PMID 11204501 · NCT01276522 · Schnitzler Syndrome

1998 (1 paper)

  1. Cancer phase I clinical trials: efficient dose escalation with overdose control.
    Babb J, Rogatko A, Zacks S, et al. · Stat Med · 1998 · Background
    PubMed: PMID 9618772 · NCT04581343 (PanCAN-SR1)

1996 (1 paper)

  1. Functions of interleukin 1 receptor antagonist in gene knockout and overproducing mice.
    Hirsch E, Irikura VM, Paul SM, et al. · Proc Natl Acad Sci U S A · 1996 · Background
    PubMed: PMID 8855299 · NCT00770601 · Cryopyrin-Associated Periodic Syndromes

Sources and methodology

This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).