Methotrexate (Rheumatrex) High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)

Rheumatrex High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)

This Investigation is to be performed for the purpose of assessing the following information in the long-term post-marketing daily medical practice in the patients who receive REUMATOLEX 2 mg Capsule for the treatment of Rheumatoid Arthritis (RA) at the dose higher than 8 mg/week.

1. Condition of occurrence of ADRs
2. Factors considered to affect safety
3. Verification of efficacy

Implemented as a Special Investigation by Central Registration System

Inclusion Criteria:

• Patients need to be administered Rheumatrex in order to be enrolled in the survey
• Patients who receive the Rheumatrex at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis

Exclusion Criteria:

• Patients who have been treated with Rheumatrex at the dose higher than 8 mg/week since the days when the high dose therapy for RA was not approved
• Patients who have been treated MTX other than Rheumatrex administered Rheumatrex