Phase 2
Completed N=301
Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis
Source: ClinicalTrials.gov NCT01061723 ↗Enrolled (actual)
301
Serious AEs
2.3%
Results posted
Aug 2017
Primary outcomePrimary: Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12 — 24.0; 24.5; 30.0; 19.2 percentage of participants — p=0.966
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved 20% Response According to the Assessment in Ankylosing Spondylitis (AS) Working Group Criteria for Response (ASAS20) at Week 12 |
24.0; 24.5; 30.0; 19.2; 30.0; 38.0 | 0.966 |
| SECONDARY Percentage of Participants Who Achieved 40% Response According to the Assessment in AS Working Group Criteria for Response (ASAS40) at Week 12 |
8.0; 14.3; 16.0; 5.8; 18.0; 20.0 | — |
| SECONDARY Percentage of Participants Who Achieved Partial Remission According to the Assessment in AS Working Group Criteria for Response (ASAS) at Week 12 |
2.0; 8.2; 2.0; 1.9; 2.0; 8.0 | — |
| SECONDARY Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) at Week 12 |
-0.4; -0.5; -0.8; -1.1; -1.2; -1.6 | — |
| SECONDARY Change From Baseline in BASDAI Score at Week 12 |
-0.9; -0.8; -1.1; -0.4; -0.9; -1.2 | — |
| SECONDARY Change From Baseline in Range of Motion Assessed by the Bath AS Metrology Index (BASMI) at Week 12 |
-0.2; -0.2; -0.2; -0.4; -0.1; -0.2 | — |
| SECONDARY Change From Baseline in Magnetic Resonance Imaging (MRI) Score of the Spine Assessed by the Berlin Modification of the AS Spine MRI-active (ASspiMRI-a) Score at Week 12 |
-0.5; -0.5; -0.1; 0.1; -0.3; 0.3 | — |
| SECONDARY Percentage of Participants Who Achieved ASAS 5/6 Improvement Criteria at Week 12 |
6.0; 12.2; 10.0; 13.5; 14.0; 32.0 | — |
| SECONDARY Change From Baseline in Chest Expansion at Week 12 |
0.2; 0.2; 0.0; -0.1; 0.1; 0.3 | — |
| SECONDARY Change From Baseline in Swollen Joint Index at Week 12 |
-0.4; -0.8; -0.3; -0.3; -0.4; -0.2 | — |
| SECONDARY Change From Baseline in Hs-CRP at Week 12 |
-3.7; -1.2; -5.8; -13.5; -11.5; -14.3 | — |
| SECONDARY Change From Baseline in ASAS Individual Components at Week 12 |
-1.0; -1.1; -0.8; -0.4; -0.9; -1.6 | — |
Eligibility Criteria
Inclusion criteria
- Diagnosis of AS according to the New York modified criteria
- Participants must had an adequate trial of at least 2 different Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) taken for at least 2 weeks in each case and, on a stable dose for ≥2 weeks or be intolerant to NSAIDs
- Participants must had active AS for ≥3 months before screening and active disease must be present at screening and at baseline; Active AS being defined by:
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥4 (Numerical Rating Scale 0-10)
- Total back pain score ≥4 (Numerical Rating Scale 0-10)
Participants treated with corticosteroid must be on a stable dose for ≥2 weeks prior to baseline
Participants treated with the Disease Modifying Anti-Rheumatic Drugs (DMARDs) hydroxychloroquine, sulfasalazine and methotrexate (MTX) must be on stable dose ≥12 weeks prior to baseline
Exclusion criteria
- 25 mg/week
- hydroxychloroquine >400 mg/day
- Sulfasalazine >3 g/day
- Treatment with oral prednisone or equivalent corticosteroids >10 mg/day within 6 weeks prior to screening
- Use of intramuscular or intra-articular corticosteroids within the last 4 weeks before screening
- Previous treatment with cyclosporine, azathioprine
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT01061723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.