N/A
N=2,860
Methotrexate (Rheumatrex) High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)
Arthritis · Rheumatoid · High Dose
Bottom Line
View on ClinicalTrials.gov: NCT01414257 ↗Enrolled (actual)
2,860
Serious AEs
2.4%
Results posted
Aug 2018
Primary outcome: Primary: Number of Participants With Treatment-Related Adverse Events — 608 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Methotrexate (MTX) (Drug)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Related Adverse Events |
608 | — |
| PRIMARY Disease Activity Score (DAS28)-4ESR |
4.09; 3.21 | — |
| PRIMARY Disease Activity Score (DAS28)-4CRP |
3.55; 2.66 | — |
| PRIMARY Change From Baseline in Disease Activity Score (DAS28)-4ESR |
-0.88 | — |
| PRIMARY Change From Baseline in Disease Activity Score (DAS28)-4CRP |
-0.89 | — |
| SECONDARY Number of Participants With Treatment-Related Serious Adverse Events |
47 | — |
| SECONDARY Number of Participants With Treatment Related Pre-specified Important Serious Adverse Events |
7; 0; 1; 1; 3; 28 | — |
| SECONDARY Clinical Efficacy Rate |
80.2 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT01414257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.