Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP

Chugai Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: MRA(Tocilizumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00144547

MRA214JP

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 MRA012JP.

Enrollment: 241 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Patients must suffer from RA, and must have participated in the preceding study.
• Patients must have been confirmed to be appropriate on week 52 of the preceding study by X radiography.

Exclusion criteria

• Patients evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug
• Patients who have not been registered by 3 months after week 52 of the preceding study

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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241 participants in 1 patient group

1

Experimental group

Treatment:

Drug: MRA(Tocilizumab)