Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP

Chugai Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: MRA (Tocilizumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00144534

MRA215JP

Details and patient eligibility

About

This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA213JP.

Enrollment: 115 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Either MRA or placebo was administered at least 3 times in the preceding study, and there were confirmed to be no problems with respect to safety.
• In the case of Patients whose participation in the current study was judged to be inappropriate because of problems in the preceding study with respect to safety, these Patients must have been in the methotrexate dose group in the preceding study.

Exclusion criteria

• Administered drugs such as infliximab, etanercept, and leflunomide within 12 weeks before administration of the study drug
• Evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug
• Have not been registered by 3 months after the full code-breaking of the preceding study
• Were administered plasma exchange therapy between initiation of the preceding study and the initial administration in the current study
• Treated surgically (except for local surgery) within 4 weeks before administration of the study drug

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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115 participants in 1 patient group

1

Experimental group

Treatment:

Drug: MRA (Tocilizumab)