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

NCT ID: NCT01414257

Last Updated: 2018-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2860 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2014-03-31

Brief Summary

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

Detailed Description

Implemented as a Special Investigation by Central Registration System

Conditions

Arthritis; Rheumatoid; High Dose

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Methotrexate (MTX)

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

Methotrexate (MTX)

Intervention Type: DRUG

Methotrexate should be administered at the weekly dose of 6 mg orally once a week or twice or three times a week by subdividing the weekly dose into the relevant number of portions. When administering the subdivided doses, MTX should be administered at the interval of 12 hours on Day 1 to Day 2. When the weekly dose is subdivided into two portions, suspend the administration for the remaining 6 days. When the weekly dose is subdivided into three portions, suspend the administration on the remaining 5 days. Repeat this weekly cycle. The dose should be adjusted as appropriate depending on the age, symptom, tolerability, and response to the MTX Preparation in individual patients. The weekly dose should not be higher than 16 mg.

Interventions

Methotrexate (MTX)

Methotrexate should be administered at the weekly dose of 6 mg orally once a week or twice or three times a week by subdividing the weekly dose into the relevant number of portions. When administering the subdivided doses, MTX should be administered at the interval of 12 hours on Day 1 to Day 2. When the weekly dose is subdivided into two portions, suspend the administration for the remaining 6 days. When the weekly dose is subdivided into three portions, suspend the administration on the remaining 5 days. Repeat this weekly cycle. The dose should be adjusted as appropriate depending on the age, symptom, tolerability, and response to the MTX Preparation in individual patients. The weekly dose should not be higher than 16 mg.

Intervention Type: DRUG

Other Intervention Names

Rheumatrex

Eligibility Criteria

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

University of Occupational and Environmental Health Hospital

Kitakyushu-shi, Fukuoka, Japan

Countries

Japan

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3211003&StudyName=Methotrexate%20%28Rheumatrex%29%20High%20Dose%20Special%20Investigation%20%28regulatory%20Post%20Marketing%20Commitment%20Plan%29%20

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Other Identifiers

B3211003

Identifier Type: -

Identifier Source: org_study_id