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

Pfizer

Status: Completed

Conditions: Arthritis; High Dose; Rheumatoid

Treatments: Drug: Methotrexate (MTX)

Study type: Observational

Funder types: Industry

Identifiers

NCT01414257

B3211003

Details and patient eligibility

About

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

Full description

Implemented as a Special Investigation by Central Registration System

Enrollment: 2,860 patients

Sex: All

Ages: 17 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,860 participants in 1 patient group

Methotrexate (MTX)

Description:

Patients who receive the MTX Preparation at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis.

Treatment:

Drug: Methotrexate (MTX)