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

NCT01414257 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2860

Last updated 2018-08-06

Study results available
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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

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
17 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Japan

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01414257 on ClinicalTrials.gov