Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JP

Chugai Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: MRA(Tocilizumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00144586

MRA222JP

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 MRA220JP or MRA221JP.

Enrollment: 42 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• RA patients who participated in the previous studies
• Patients who completed the last observation in the previous studies
• Patients who were confirmed to have no problems with safety in the previous studies.

Exclusion criteria

• Patients with Class IV Steinbrocker functional disorder at evaluation within 4 weeks before treatment with the investigational product
• Patients who were not enrolled by 3 months after the last observation day of the previous study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

1

Experimental group

Treatment:

Drug: MRA(Tocilizumab)