Phase 3
Completed N=1,675
Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients
Source: ClinicalTrials.gov NCT01061736 ↗Enrolled (actual)
1,675
Serious AEs
7.2%
Results posted
Jun 2017
Primary outcomePrimary: Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 — 62; 72; 49; 66.7 Percentage of participants — p=0.1155
Summary
Primary Objectives:
Part A (dose ranging study):
To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks.
Part B (pivotal study):
To demonstrate that sarilumab added to MTX was effective in:
* reduction of signs and symptoms of rheumatoid arthritis at 24 weeks
* inhibition of progression of structural damage at 52 weeks
* improvement in physical function at 16 weeks
Secondary Objectives:
Part B:
To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks
To assess the safety of sarilumab added to MTX
To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 |
62; 72; 49; 66.7; 65.4; 46.2 | 0.1155 |
| PRIMARY Part B: Percentage of Participants Achieving ACR20 Response at Week 24 |
58; 66.4; 33.4 | <0.0001 sig |
| PRIMARY Part B: Change From Baseline in Health Assessment Question Disability Index (HAQ-DI) at Week 16 |
1.63; 1.69; 1.61; 1.08; 1.11; 1.31 | <0.0001 sig |
| PRIMARY Part B: Change From Baseline in Van Der Heijde Modified Total Sharp Score (mTSS) at Week 52 |
54.67; 46.34; 48.01; 55.57; 46.59; 50.79 | <0.0001 sig |
| SECONDARY Part B: Percentage of Participants Achieving a Major Clinical Response at Week 52 |
12.8; 14.8; 3 | <0.0001 sig |
Eligibility Criteria
Inclusion criteria
- Diagnosis of rheumatoid arthritis ≥3 months duration
- Active disease defined as:
- at least 8/68 tender joints and 6/66 swollen joints,
- high sensitivity C-reactive protein (hs-CRP) >6 mg/l,
- continuous treatment with MTX for at least 12 weeks prior to baseline visit and on stable dose for at least 6 weeks prior to screening visit.
Part B only:
- Bone erosion based on documented X-ray prior to first study drug intake, or
- Cyclic Citrullinated Peptide (CCP) positive, or
- Rheumatoid Factor (RF) positive.
Exclusion criteria
- Age 75 years.
- Treatment with disease-modifying antirheumatic drugs (DMARDs) other than MTX within 4 weeks or 12 weeks prior to screening (depending on DMARDs).
- Past history of non-response to prior Tumor Necrosis Factor (TNF) or biologic treatment.
- Any past or current biologic agents for the treatment of rheumatoid arthritis within 3 months.
- Use of parenteral glucocorticoids or intraarticular glucocorticoids within 4 weeks prior to screening visit.
- Use of oral glucocorticoid greater than 10mg/day or equivalent/day, or a change in dosage within 4 weeks prior to baseline visit.
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT01061736). 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.