16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02008916
Phase
PHASE3
Status
Completed

Conditions

  • Spondylitis, Ankylosing

Eligibility Criteria

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

Interventions

  • Secukinumab — DRUG
    AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17).
  • Placebo secukinumab — DRUG
    Placebo to AIN457 (Secukinumab)

Study Details

The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.

Key Dates

Start date
Jan 14, 2014
Status verified
Dec 2018
Primary completion
Feb 23, 2015
Completion
Dec 11, 2017

Study Design

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

Arms

  • Experimental: Secukinumab 10 mg/kg i.v. / 300 mg s.c.
    Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
  • Experimental: Secukinumab 10 mg/kg i.v. / 150 mg s.c.
    Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
  • Placebo Comparator: Placebo i.v. and s.c.
    Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection at weeks 8 and 12. At week 16, patients were re-randomised to one of the active treatment arms, to receive secukinumab s.c. Q4W until the end of the study.

Primary Outcome Measure

Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response [ Time Frame: 16 weeks ]

Locations (14)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteMobileAlabama36604-
Novartis Investigative SiteMesaArizona85202-
Novartis Investigative SitePeoriaArizona85381-
Novartis Investigative SiteUplandCalifornia91786-
Novartis Investigative SitePalm HarborFlorida34684-
Novartis Investigative SitePembroke PinesFlorida33026-
Novartis Investigative SitePassaicNew Jersey07055-
Novartis Investigative SiteAlbanyNew York12206-
Novartis Investigative SiteOklahoma CityOklahoma73103-
Novartis Investigative SiteDuncansvillePennsylvania16635-
Novartis Investigative SiteCharlestonSouth Carolina29460-
Novartis Investigative SiteJacksonTennessee38305-
Novartis Investigative SiteAustinTexas78731-
Novartis Investigative SiteMesquiteTexas75150-

Find similar trials in Mobile, AL

By research site
Novartis Investigative Site· Mobile, ALNovartis Investigative Site· Mesa, AZNovartis Investigative Site· Peoria, AZNovartis Investigative Site· Upland, CANovartis Investigative Site· Palm Harbor, FLNovartis Investigative Site· Pembroke Pines, FL

Related Studies