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

Last updated on November 5, 2019

FOR MORE INFORMATION
Study Location
University of Occupational and Environmental Health Hospital
Kitakyushu-shi, Fukuoka-ken, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Arthritis, Rheumatoid, High Dose
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
17-99 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01414257
Pfizer
Completed
Methotrexate (Rheumatrex) High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)

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Descriptive Information
Brief TitleMethotrexate (Rheumatrex) High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)
Official TitleRheumatrex High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)
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 DescriptionImplemented as a Special Investigation by Central Registration System
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodProbability Sample
Study PopulationPatients who receive the MTX Preparation at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis.
Condition
  • Arthritis
  • Rheumatoid
  • High Dose
InterventionDrug: 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
Study Groups/CohortsMethotrexate (MTX)
Patients who receive the MTX Preparation at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis.
Intervention: Drug: Methotrexate (MTX)
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: November 8, 2017)
2860
Original Estimated Enrollment
 (submitted: August 9, 2011)
3000
Actual Study Completion DateMarch 2014
Actual Primary Completion DateMarch 2014   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study:All
Ages17 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesJapan
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01414257
Other Study ID NumbersB3211003
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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