Study to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02763046
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Secukinumab (AIN457) 150 mg s.c. — DRUG
    Induction: 5 x 150 mg secukinumab s.c. weekly Maintenance: 4 x 150 mg secukinumab s.c. every 4 weeks Delayed NSAID tapering (tapering following 4 weeks of secukinumab treatment).
  • Secukinumab (AIN457) 150 mg s.c. — DRUG
    Induction: 5 x 150 mg secukinumab s.c. weekly Maintenance: 3 x 150 mg secukinumab s.c. every 4 weeks Early NSAID tapering (tapering at the start of secukinumab treatment).
  • Placebo - Secukinumab (AIN457) 150 mg s.c. — DRUG
    Placebo for 15 weeks. From Week 16 on, 5 x 150 mg secukinumab s.c. weekly.

Study Details

This study assessed the clinical Assessment of SpondyloArthritis international Society (ASAS) 20 response to secukinumab and evaluated to which extent concomitant nonsteroidal anti-inflammatory drug (NSAID) treatment can be reduced in patients treated with secukinumab or placebo following an initial run-in phase of stable NSAID therapy.

Key Dates

Start date
May 31, 2016
Status verified
Oct 2021
Primary completion
Sep 24, 2019
Completion
Sep 24, 2019

Study Design

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

Arms

  • Experimental: Secukinumab - delayed NSAID tapering
    Induction with secukinumab 150 mg s.c. once per week (Week 0, 1, 2, 3 and 4) followed by maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 8, 12, 16 and 20), with intermittent placebo injections at Week 5, 6, 7, 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (delayed tapering).
  • Experimental: Secukinumab - early NSAID tapering
    Placebo at weeks 0, 1, 2, 3 to maintain the blind; followed by induction with secukinumab 150 mg s.c. once per week (Week 4, 5, 6, 7, 8) and maintenance with secukinumab 150 mg s.c. every 4 weeks (Week 12, 16 and 20), with intermittent placebo injections at Week 17, 18 and 19 to maintain the blind. NSAID tapering allowed from Week 4 (early tapering).
  • Placebo Comparator: Placebo
    Placebo s.c. at Week 0, 1, 2, 3, 4, 5, 6, 7, 8 and 12. After the Week 16 assessments of the secondary endpoint had been performed, these patients received weekly doses of secukinumab 150 mg s.c. (Week 16, 17, 18, 19 and 20). NSAID tapering allowed from Week 4.

Primary Outcome Measure

Proportion of Patients Who Achieved ASAS20 Response in the Pooled Secukinumab Group Compared With the Placebo Group at Week 12 [ Time Frame: Baseline, Week 12 ]

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