Methotrexate (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.
- Condition of occurrence of ADRs
- Factors considered to affect safety
- Verification of efficacy
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Rheumatrex High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)|
- Disease Activity Score (DAS28)-4ESR/4CRP [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Assess clinical efficacy to 2 levels; "effective" or "ineffective" based on the degree of alleviation of RA and laboratory data [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2011|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Patients who receive the MTX Preparation at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis.
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.
Other Name: Rheumatrex
Implemented as a Special Investigation by Central Registration System
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414257
|Contact: Pfizer CT.gov Call Center||1-800-718-1021|
|University of Occupational and Environmental Health Hospital||Recruiting|
|Kitakyushu-shi, Fukuoka-ken, Japan|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|