Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments sarilumab sar153191 (regn88), non-mtx dmards (e.g. sulfasalazine, leflunomide, bucillamine, tacrolimus, or mizoribin), sulfasalazine, leflunomide, bucillamine, tacrolimus, mizoribin
Phase phase 3
Sponsor Sanofi
Collaborator Regeneron Pharmaceuticals
Start date February 2015
End date November 2016
Trial size 90 participants
Trial identifier NCT02373202, LTS13618, U1111-1160-6525

Summary

Primary Objective:

To document the long-term safety of sarilumab added to non-methotrexate (non-MTX) disease-modifying antirheumatic drugs (DMARDs) or as monotherapy.

Secondary Objective:

To document the long term efficacy of sarilumab added to non-MTX DMARDs or as monotherapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Subcutaneous (SC) injection of Dose 1 once in 2 weeks (q2w) non-MTX DMARDs (e.g. sulfasalazine, leflunomide, bucillamine, tacrolimus, or mizoribin) (stable dose) are continued as background therapy.
sarilumab sar153191 (regn88)
Pharmaceutical form:solution Route of administration: subcutaneous
non-mtx dmards (e.g. sulfasalazine, leflunomide, bucillamine, tacrolimus, or mizoribin)
sulfasalazine
Pharmaceutical form: tablet Route of administration: oral
leflunomide
Pharmaceutical form: tablet Route of administration: oral
bucillamine
Pharmaceutical form: tablet Route of administration: oral
tacrolimus
Pharmaceutical form: capsule Route of administration: oral
mizoribin
Pharmaceutical form: tablet Route of administration: oral
(Experimental)
SC injection of Dose 2 q2w non-MTX DMARDs (e.g. sulfasalazine, leflunomide, bucillamine, tacrolimus, or mizoribin) (stable dose) are continued as background therapy.
sarilumab sar153191 (regn88)
Pharmaceutical form:solution Route of administration: subcutaneous
non-mtx dmards (e.g. sulfasalazine, leflunomide, bucillamine, tacrolimus, or mizoribin)
sulfasalazine
Pharmaceutical form: tablet Route of administration: oral
leflunomide
Pharmaceutical form: tablet Route of administration: oral
bucillamine
Pharmaceutical form: tablet Route of administration: oral
tacrolimus
Pharmaceutical form: capsule Route of administration: oral
mizoribin
Pharmaceutical form: tablet Route of administration: oral
(Experimental)
SC injection of Dose 3 q2w
sarilumab sar153191 (regn88)
Pharmaceutical form:solution Route of administration: subcutaneous
(Experimental)
SC injection of Dose 4 q2w
sarilumab sar153191 (regn88)
Pharmaceutical form:solution Route of administration: subcutaneous

Primary Outcomes

Measure
Number of treatment-emergent adverse events
time frame: 58 weeks
Clinically significant changes in vital signs
time frame: 58 weeks
Clinically significant changes in electrocardiogram (ECG)
time frame: 58 weeks
Clinically significant changes in laboratory values
time frame: 58 weeks

Secondary Outcomes

Measure
Percentage of patients achieving ACR20/50/70 responses
time frame: 58 weeks
Change from baseline in Disease Activity Score 28 (DAS28)-CRP
time frame: 58 weeks
Change from baseline in Health Assessment Questionnaire-Disability Index scores
time frame: 58 weeks

Eligibility Criteria

Male or female participants at least 20 years old.

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) ≥4mg/L or Erythrocyte sedimentation rate (ESR) ≥28 mm/hr at screening visit. For the combination stratum: Patients who had continuous treatment with non-biologic DMARDs other than MTX for at least 12 weeks prior to the randomization. OR Patients who per investigator judgment were any of inappropriate, intolerant or inadequate to MTX treatment. Exclusion criteria: Patients <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 is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Additional Information

Official title A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis
Description Total study duration is up to 62 weeks: Up to 4-week screening period, 52-week treatment period, and 6-week post-treatment follow-up period.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Sanofi.