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

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ClinicalTrials.gov Identifier: NCT01414257
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Arthritis Rheumatoid High Dose Drug: Methotrexate (MTX)

Detailed Description:
Implemented as a Special Investigation by Central Registration System

Study Design

Study Type : Observational
Actual Enrollment : 2882 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Rheumatrex High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)
Study Start Date : May 2011
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Methotrexate (MTX)
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


Outcome Measures

Primary Outcome Measures :
  1. Disease Activity Score (DAS28)-4ESR/4CRP [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Assess clinical efficacy to 2 levels; "effective" or "ineffective" based on the degree of alleviation of RA and laboratory data [ Time Frame: 24 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who receive the MTX Preparation at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414257


Locations
Japan
University of Occupational and Environmental Health Hospital
Kitakyushu-shi, Fukuoka-ken, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01414257     History of Changes
Other Study ID Numbers: B3211003
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015

Keywords provided by Pfizer:
Rheumatrex
High Dose

Additional relevant MeSH terms:
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors