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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)

NCT02373202 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2018-01-30

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-11-30
Completion
2016-11-30
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02373202 on ClinicalTrials.gov