Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2026-01-01 @ 9:41 AM
Study NCT ID:
NCT01414257
Status:
COMPLETED
Last Update Posted:
2018-08-06
First Post:
2011-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Methotrexate (Rheumatrex) High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)
Sponsor:
Pfizer
Organization:
Study Overview
Official Title:
Rheumatrex High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: