24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis

Part of paid clinical trials in Aventura, Florida.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01989468
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Secukinumab — BIOLOGICAL
    Secukinumab 150 mg provided in a 1 mL autoinjector (1 autoinjector for 150 mg dose, 2 autoinjectors for 300 mg dose)
  • Placebo — BIOLOGICAL
    Secukinumab placebo provided in 1 mL autoinjector

Study Details

The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data, and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID), disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis factor alpha (TNFα) therapy.

Key Dates

Start date
Apr 10, 2014
Status verified
Apr 2019
Primary completion
May 27, 2015
Completion
Mar 28, 2018

Study Design

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

Arms

  • Experimental: Secukinumab (AIN457) 150 mg s.c.
    1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
  • Experimental: Secukinumab (AIN457) 300 mg s.c.
    2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
  • Placebo Comparator: Placebo
    Matching Placebo at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.

Primary Outcome Measure

Proportion of Patients Achieving American College of Rheumatology 20 (ACR20) Response Criteria on Secukinumab Versus Placebo at Week 24 [ Time Frame: Week 24 ]

Locations (12)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteAventuraFlorida33180-
Novartis Investigative SitePalm HarborFlorida34684-
Novartis Investigative SiteSarasotaFlorida34239-
Novartis Investigative SiteIndianapolisIndiana46256-
Novartis Investigative SiteBowling GreenKentucky42101-
Novartis Investigative SiteSt LouisMissouri63117-
Novartis Investigative SiteFreeholdNew Jersey07728-
Novartis Investigative SiteAlbanyNew York12206-
Novartis Investigative SiteDuncansvillePennsylvania16635-
Novartis Investigative SiteAustinTexas78731-
Novartis Investigative SiteMesquiteTexas75150-
Novartis Investigative SiteWenatcheeWashington98801-

Find similar trials in Aventura, FL

By condition
Psoriatic arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Novartis Investigative Site· Aventura, FLNovartis Investigative Site· Palm Harbor, FLNovartis Investigative Site· Sarasota, FLNovartis Investigative Site· Indianapolis, INNovartis Investigative Site· Bowling Green, KYNovartis Investigative Site· St Louis, MO

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