Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)

Part of paid clinical trials in Mesa, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03259074
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • AIN457 150 mg — BIOLOGICAL
    150 mg in pre-filled syringes was administered subcutaneously
  • Placebo — BIOLOGICAL
    Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes
  • GP2017 (adalimumab biosimilar) — BIOLOGICAL
    40 mg in pre-filled syringes was administered subcutaneously

Study Details

The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).

Key Dates

Start date
Nov 30, 2017
Status verified
Aug 2023
Primary completion
Nov 12, 2021
Completion
Nov 29, 2021

Study Design

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

Arms

  • Experimental: AIN457 150 mg/placebo
    AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100
  • Experimental: AIN457 300 mg
    AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100
  • Active Comparator: GP2017 40mg
    GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 102

Primary Outcome Measure

Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set) [ Time Frame: Baseline and at Week 104 ]

Locations (19)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteMesaArizona85202-
Novartis Investigative SiteEscondidoCalifornia92025-
Novartis Investigative SiteLa MesaCalifornia91942-
Novartis Investigative SiteSan FranciscoCalifornia94143 0138-
Novartis Investigative SiteGainesvilleFlorida32607-
Novartis Investigative SiteBoiseIdaho83702-
Novartis Investigative SiteShreveportLouisiana71101-
Novartis Investigative SiteWheatonMaryland20902-
Novartis Investigative SiteGreat FallsMontana59405-
Novartis Investigative SiteLincolnNebraska68516-
Novartis Investigative SiteGreensboroNorth Carolina27408-
Novartis Investigative SiteDaytonOhio45402-
Novartis Investigative SiteMiddleburg HeightsOhio44130-
Novartis Investigative SitePortlandOregon97239-
Novartis Investigative SiteDuncansvillePennsylvania16635-
Novartis Investigative SiteMemphisTennessee38119-
Novartis Investigative SiteMesquiteTexas75150-
Novartis Investigative SiteKennewickWashington99336-
Novartis Investigative SiteFranklinWisconsin53132-

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By research site
Novartis Investigative Site· Mesa, AZNovartis Investigative Site· Escondido, CANovartis Investigative Site· La Mesa, CANovartis Investigative Site· San Francisco, CANovartis Investigative Site· Gainesville, FLNovartis Investigative Site· Boise, ID

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