A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)
Source: ClinicalTrials.gov NCT02373202 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
14; 13; 25; 28; 0; 3 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Vital Signs Abnormalities |
0; 0; 0; 0; 1; 1 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Hematological Parameters |
0; 1; 1; 3; 0; 0 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Metabolic Parameters |
0; 0; 1; 1; 0; 1 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Electrolytes |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Renal Function Parameters |
0; 0; 0; 1; 3; 3 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Laboratory Abnormalities: Liver Function Parameters |
3; 4; 7; 6; 2; 1 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology (ACR) 20, 50 and 70 Responses at Week 52 |
73.3; 40.0; 76.7; 74.2; 60.0; 33.3 | — |
| SECONDARY Change From Baseline at Week 52 in Disease Activity Score for 28 Joints Based on C-Reactive Protein (DAS28-CRP) |
-2.90; -2.47; -2.62; -2.64 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 52 |
-0.52; -0.34; -0.48; -0.38 | — |
Eligibility Criteria
Inclusion criteria
Diagnosis of rheumatoid arthritis (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 4 of 68 tender joints and 4 of 66 swollen joints at screening visit.
- High sensitivity C-Reactive Protein (hs-CRP) >=4 mg/L or Erythrocyte Sedimentation Rate (ESR) >=28 mm/hr at screening visit.
For the combination stratum:
Participants who had continuous treatment with non-biologic DMARDs other than MTX for at least 12 weeks prior to the randomization and on a stable dose for a minimum of 6 weeks prior to screening.
For the monotherapy stratum:
Participants who per investigator judgment were any of inappropriate, intolerant or inadequate to MTX treatment.
Exclusion criteria
Participants <20 years of age. Prior treatment with tumor necrosis factor (TNF) antagonists or any other RA-directed biologic agents 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 (NCT02373202). 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.