Phase 3
Completed N=243
A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)
Source: ClinicalTrials.gov NCT02293902 ↗Enrolled (actual)
243
Serious AEs
7.6%
Results posted
Jan 2018
Primary outcomePrimary: Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 — 14.8; 67.9; 57.5 percentage of participants — p=<0.0001
◆ Published Evidence
Established
46citations · ~7 / year
Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a randomized, placebo-controlled phase III trial in Japan.
Summary
Primary Objective:
-To demonstrate that sarilumab added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Japanese RA participants with an inadequate response to MTX.
Secondary Objective:
-To assess the safety of sarilumab added to MTX in Japanese RA participants with an inadequate response to MTX.
Linked Publications (2)
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Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a randomized, placebo-controlled phase III trial in Japan.
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Haemoglobin changes and disease activity in Japanese patients with rheumatoid arthritis treated with sarilumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 |
14.8; 67.9; 57.5 | <0.0001 sig |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
49; 76; 71; 12; 13; 54 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities |
2; 4; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities |
6; 9; 5; 0; 2; 6 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters |
9; 4; 5; 0; 1; 5 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters |
0; 0; 2; 1; 1; 2 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters |
0; 1; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters |
3; 17; 24; 3; 6; 16 | — |
Eligibility Criteria
Inclusion criteria
- Diagnosis of RA, according to the American College of Rheumatology/The European League Against Rheumatism (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria with >=3 months disease duration.
- Moderately to severely active RA defined as:
- At least 8 of 68 tender joints and 6 of 66 swollen joints at screening visit.
- High sensitivity C-Reactive Protein (hs-CRP) >=6mg/L at screening visit.
Exclusion criteria
- Participants 75 years of age.
- Treatment with any Disease-modifying antirheumatic drug (DMARD) other than MTX or biologic agent without the appropriate off-drug period prior to screening.
- Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.
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 (NCT02293902) and the linked publication. 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.