Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.

Part of paid clinical trials in Peoria, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01770379
Phase
PHASE3
Status
Terminated

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 — BIOLOGICAL

Study Details

This study will provide efficacy and safety data of the secukinumab pre-filled syringe (PFS) for subcutaneous self-administration in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents.

Key Dates

Start date
Oct 31, 2012
Status verified
Jun 2016
Primary completion
May 31, 2015
Completion
May 31, 2015

Study Design

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

Arms

  • Experimental: Secukinumab 75 mg
    Secukinumab 75 mg s.c.
  • Experimental: Secukinumab 150 mg
    Secukinumab 150 mg s.c.
  • Placebo Comparator: Placebo
    Placebo patients will be re-randomized 1:1 to secukinumab 75 or 150mg s.c. (non-responders at Week 16 will be re-assigned to new treatment at Week 16; responders at Week 16 will be re-assigned to new treatment at Week 24)

Primary Outcome Measure

Percentage of Participants Achieving an American College of Rheumatology Response 20 (ACR20). [ Time Frame: Week 24 ]

Locations (25)

FacilityCityStateZIPSite coordinators
Novartis Investigative SitePeoriaArizona85381-
Novartis Investigative SiteSanta MonicaCalifornia90404-
Novartis Investigative SiteUplandCalifornia91786-
Novartis Investigative SiteMiamiFlorida33135-
Novartis Investigative SitePembroke PinesFlorida33026-
Novartis Investigative SiteZephyrhillsFlorida33542-
Novartis Investigative SiteCumberlandMaryland21502-
Novartis Investigative SiteEdinaMinnesota55435-
Novartis Investigative SiteTupeloMississippi38801-
Novartis Investigative SiteLees SummitMissouri64086-
Novartis Investigative SiteSt LouisMissouri63128-
Novartis Investigative SiteRenoNevada89502-
Novartis Investigative SiteAlbuquerqueNew Mexico87102-
Novartis Investigative SiteZanesvilleOhio43701-
Novartis Investigative SiteOklahoma CityOklahoma73103-
Novartis Investigative SiteOklahoma CityOklahoma73134-
Novartis Investigative SiteNorth CharlestonSouth Carolina29406-
Novartis Investigative SiteRapid CitySouth Dakota57701-
Novartis Investigative SiteJacksonTennessee38305-
Novartis Investigative SiteNashvilleTennessee37203-1424-
Novartis Investigative SiteAmarilloTexas79124-
Novartis Investigative SiteBenbrookTexas76126-
Novartis Investigative SiteHoustonTexas77005-
Novartis Investigative SiteHoustonTexas77034-
Novartis Investigative SiteMesquiteTexas75150-

Find similar trials in Peoria, AZ

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Novartis Investigative Site· Peoria, AZNovartis Investigative Site· Santa Monica, CANovartis Investigative Site· Upland, CANovartis Investigative Site· Miami, FLNovartis Investigative Site· Pembroke Pines, FLNovartis Investigative Site· Zephyrhills, FL

Related Studies