Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis

Part of paid clinical trials in Peoria, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01752634
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Secukinumab (AIN457) — DRUG
    Secukinumab (AIN457)
  • Placebo — DRUG
    Placebo PFS for s.c. administration.

Study Details

This study was to provide 24 - 52 week efficacy, safety and tolerability data to support the registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self administration in subjects with active PsA despite current or previous NSAID, DMARD and/or anti-TNFα therapy. An additional 4 years of long-term efficacy and safety data were collected during the post Week 52 period of the study.

Key Dates

Start date
Apr 14, 2013
Status verified
Apr 2020
Primary completion
May 12, 2014
Completion
Jan 9, 2019

Study Design

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

Arms

  • Experimental: Secukinumab (AIN457) 75 mg s.c.
    Secukinumab 75 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4.
  • Experimental: Secukinumab (AIN457) 150 mg s.c.
    Secukinumab 150 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4.
  • Experimental: Secukinumab (AIN457) 300 mg s.c.
    Secukinumab 300 mg at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4
  • Placebo Comparator: Placebo s.c.
    Placebo at BSL, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4. Non-responder (assessed at Week 16) were re-randomized to receive AIN457 150mg or AIN457 300 mg starting at Week 16. Responder (assessed at Week 16) were re-randomized to receive AIN457 150mg or AIN457 300 mg starting at Week 24.

Primary Outcome Measure

Number of Participants Achieving American College of Rheumatology 20 (ACR20) Response Criteria [ Time Frame: Week 24 ]

Locations (21)

FacilityCityStateZIPSite coordinators
Novartis Investigative SitePeoriaArizona85381-
Novartis Investigative SiteAventuraFlorida33180-
Novartis Investigative SitePalm HarborFlorida34684-
Novartis Investigative SiteSarasotaFlorida34239-
Novartis Investigative SiteTamaracFlorida33321-
Novartis Investigative SiteTampaFlorida33624-
Novartis Investigative SiteZephyrhillsFlorida33542-
Novartis Investigative SiteLincolnNebraska68516-
Novartis Investigative SiteOmahaNebraska68114-
Novartis Investigative SiteFreeholdNew Jersey07728-
Novartis Investigative SiteSyracuseNew York13210-
Novartis Investigative SiteAshevilleNorth Carolina28801-
Novartis Investigative SiteCharlotteNorth Carolina28210-
Novartis Investigative SiteOklahoma CityOklahoma73102-
Novartis Investigative SiteOklahoma CityOklahoma73103-
Novartis Investigative SiteDuncansvillePennsylvania16635-
Novartis Investigative SiteCharlestonSouth Carolina29460-
Novartis Investigative SiteColumbiaSouth Carolina29204-
Novartis Investigative SiteGreenvilleSouth Carolina29601-
Novartis Investigative SiteLeague CityTexas77573-
Novartis Investigative SiteMesquiteTexas75150-

Find similar trials in Peoria, AZ

By condition
Psoriatic arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Novartis Investigative Site· Peoria, AZNovartis Investigative Site· Aventura, FLNovartis Investigative Site· Palm Harbor, FLNovartis Investigative Site· Sarasota, FLNovartis Investigative Site· Tamarac, FLNovartis Investigative Site· Tampa, FL

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