Conditions: Ankylosing Spondylitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 301
Healthy volunteers: no

Brief summary:
Primary objective:

\- to evaluate the efficacy of Sarilumab in participants with Ankylosing Spondylitis (AS) using the assessment in AS working group criteria (ASAS) 20% response criteria (ASAS20)

Secondary objectives:

* to demonstrate that Sarilumab was effective on:

  * assessment of higher level of response \[ASAS 40% response criteria (ASAS40)\]
  * partial remission
  * disease activity
  * range of motion
  * Magnetic Resonance Imaging (MRI) of the spine
* to assess the safety and tolerability of Sarilumab in participants with AS as well as the pharmacokinetic profile of Sarilumab in participants with AS

Detailed description:
The duration of participation in this study for each participant was approximately 22 weeks; including up to 4 weeks screening period, 12-weeks double-blind treatment period and 6-weeks safety follow-up period.

Arms:
arm 1: Placebo (for sarilumab) weekly (qw) for 12 weeks. arm 2: Sarilumab 100 mg Subcutaneous (SC) injection alternating with placebo every other week (q2w) for 12 weeks. arm 3: Sarilumab 150 mg SC injection alternating with placebo q2w for 12 weeks. arm 4: Sarilumab 100 mg SC injection qw for 12 weeks. arm 5: Sarilumab 200 mg SC injection alternating with placebo q2w for 12 weeks. arm 6: Sarilumab 150 mg SC injection qw for 12 weeks.

Interventions: intervention 1: Sarilumab intervention 2: Placebo
Intervention descriptions: intervention 1: Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous intervention 2: Pharmaceutical form: Solution for injection

Route of administration: Subcutaneous

Protocol document: