16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis

Part of paid clinical trials in Mesa, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02294227
Phase
PHASE3
Status
Completed

Conditions

  • Arthritis, Psoriatic

Eligibility Criteria

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

Interventions

  • Secukinumab — BIOLOGICAL
    Secukinumab 150 mg (1 mL liquid formulation) in pre-filled syringes were supplied by Novartis. Each secukinumab 300 mg dose was given as two sc injections of secukinumab 150 mg.
  • Placebo — OTHER
    Placebo to secukinumab was also available in 1.0 mL liquid formulation in prefilled syringe to match the active drug.

Study Details

The purpose of this study was to provide 16-week efficacy, safety and tolerability data versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with active PsA despite current or previous NSAID or DMARD therapy

Key Dates

Start date
May 29, 2015
Status verified
Jun 2019
Primary completion
Feb 16, 2016
Completion
Dec 19, 2017

Study Design

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

Arms

  • Experimental: Secukinumab 150 mg
    Secukinumab 150 mg s.c. with loading: Secukinumab 150 mg at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
  • Experimental: Secukinumab 150 mg No load
    Secukinumab 150 mg s.c. without loading: Secukinumab 150 mg at baseline, followed by dosing every four weeks starting at Week 4, with Placebo at Weeks 1, 2 and 3. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator
  • Placebo Comparator: Placebo
    Placebo to Secukinumab at Baseline, Weeks 1, 2 and 3, followed by dosing every four weeks starting at Week 4 until Week 16/24, depending on patients responder status. From Week 16/24, patients were switched to Secukinumab 150 mg every four weeks. After primary outcome evaluation, approval and implementation of Amendment 2 Secukinumab dose may have been escalated to 300 mg as judged appropriate by the investigator

Primary Outcome Measure

Number of Participants With American College of Rheumatology 20 (ACR20) Response [ Time Frame: 16 weeks ]

Locations (19)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteMesaArizona85202-
Novartis Investigative SiteUplandCalifornia91786-
Novartis Investigative SiteDenverColorado80230-
Novartis Investigative SitePalm HarborFlorida34684-
Novartis Investigative SiteSarasotaFlorida34239-
Novartis Investigative SitePeoriaIllinois61602-
Novartis Investigative SiteShreveportLouisiana71101-
Novartis Investigative SiteSaint Clair ShoresMichigan48081-
Novartis Investigative SiteSt LouisMissouri63117-
Novartis Investigative SiteLincolnNebraska68516-
Novartis Investigative SiteAlbanyNew York12206-
Novartis Investigative SiteOklahoma CityOklahoma73103-
Novartis Investigative SiteDuncansvillePennsylvania16635-
Novartis Investigative SiteCharlestonSouth Carolina29460-
Novartis Investigative SiteGreenvilleSouth Carolina29601-
Novartis Investigative SiteMesquiteTexas75150-
Novartis Investigative SiteBurlingtonVermont05401-
Novartis Investigative SiteSeattleWashington98104-
Novartis Investigative SiteSeattleWashington98122-

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Novartis Investigative Site· Mesa, AZNovartis Investigative Site· Upland, CANovartis Investigative Site· Denver, CONovartis Investigative Site· Palm Harbor, FLNovartis Investigative Site· Sarasota, FLNovartis Investigative Site· Peoria, IL

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