16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis

Conditions

• Anklyosing Spondylitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Secukinumab (75 mg) — DRUG
  Secukinumab 75 mg s.c.
• Placebo — DRUG
  Placebo
• Secukinumab (150 mg) — DRUG
  Secukinumab 150 mg s.c.

Study Details

This study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor

Key Dates

Start date

Oct 18, 2012

Status verified

Oct 2019

Primary completion

Aug 4, 2014

Completion

Sep 18, 2018

Study Design

Enrollment

219 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Secukinumab 75 mg
  Secukinumab 75 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks.
• Experimental: Secukinumab 150 mg
  Secukinumab 150 mg subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks
• Placebo Comparator: Placebo
  Placebo subcutaneous injection once weekly at baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks

Primary Outcome Measure

Percentage of Participants Achieving ASAS 20 (SpondyloArthritis International Society Criteria) Response at Week 16 [ Time Frame: Baseline up to 16 weeks ]

Locations (10)

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