Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate

Part of paid clinical trials in Vestavia Hills, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01359943
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • secukinumab (AIN457) — BIOLOGICAL
    Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a "messenger" protein in the body) called Interleukin 17 (IL-17).
  • placebo — DRUG
    Matching placebo to AIN457 i.v. and to AIN457 s.c..

Study Details

The study compared the efficacy and assessed the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis (RA) despite treatment with Methotrexate.

Key Dates

Start date
Oct 31, 2011
Status verified
Feb 2015
Primary completion
Dec 31, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
221 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: secukinumab 10 mg/kg i.v. loading
    secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
  • Experimental: secukinumab 150 mg s.c. loading
    secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
  • Placebo Comparator: placebo
    placebo at Weeks 0, 1, 2, 3, 4, 8 \& 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16

Primary Outcome Measure

Percentage of Participants Who Achieve American College of Rheumatology Response of 20 (ACR20) [ Time Frame: 12 weeks ]

Locations (8)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteVestavia HillsAlabama35216-
Novartis Investigative SitePeoriaArizona85381-
Novartis Investigative SiteUplandCalifornia91786-
Novartis Investigative SiteBowling GreenKentucky42101-
Novartis Investigative SiteTupeloMississippi38801-
Novartis Investigative SiteLincolnNebraska68516-
Novartis Investigative SiteJacksonTennessee38305-
Novartis Investigative SiteNashvilleTennessee37205-

Find similar trials in Vestavia Hills, AL

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Novartis Investigative Site· Vestavia Hills, ALNovartis Investigative Site· Peoria, AZNovartis Investigative Site· Upland, CANovartis Investigative Site· Bowling Green, KYNovartis Investigative Site· Tupelo, MSNovartis Investigative Site· Lincoln, NE

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