NCT01414257

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,860 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 17 Years – 99 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2011-08-11
• Last updated: 2018-08-06
• Results posted: 2018-08-06

Locations

1 site across 1 country: Japan