NCT02373202

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)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Total study duration was up to 62 weeks: Up to 4-week screening period, 52-week treatment period, and 6-week post-treatment follow-up period.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Sarilumab	Pharmaceutical form:solution
DRUG	Sulfasalazine	Pharmaceutical form: Tablet Route of administration: Oral
DRUG	Leflunomide	Pharmaceutical form: Tablet Route of administration: Oral
DRUG	Bucillamine	Pharmaceutical form: Tablet Route of administration: Oral
DRUG	Tacrolimus	Pharmaceutical form: Capsule Route of administration: Oral
DRUG	Mizoribine	Pharmaceutical form: Tablet Route of administration: Oral

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-02-26
• Last updated: 2018-01-30
• Results posted: 2018-01-30

Locations

40 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study