Rheumatrex High Dose Special Investigation (Regulatory Post Marketing Commitment Plan)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 2,860
- Locations
- 1
- Primary Endpoint
- Number of Participants With Treatment-Related Adverse Events
Study Overview
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.
- Condition of occurrence of ADRs
- Factors considered to affect safety
- Verification of efficacy
Detailed Description
Implemented as a Special Investigation by Central Registration System
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 17 Years to 99 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Methotrexate (MTX)
Patients who receive the MTX Preparation at the dose higher than 8 mg/week for the treatment of Rheumatoid Arthritis.
Intervention: Methotrexate (MTX) (Drug)
Outcomes
Primary Outcomes
Number of Participants With Treatment-Related Adverse Events
Time Frame: 24 Weeks
A treatment-related adverse event was any untoward medical occurrence attributed to methotrexate in a participant who received methotrexate.
Disease Activity Score (DAS28)-4CRP
Time Frame: Baseline and 24 Weeks
Disease activity score based on 28-joint count and C-reactive protein (4 variables) (DAS28-4 \[CRP\]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, C-reactive protein (CRP, mg/dL) and VAS of general health. The total scale range of DAS28-4 (ESR) , minimum is 0.0 and maximum can not be specified. DAS28-4 (CRP) \>4.1 indicated high disease activity, ≥2.7 to 4.1 indicated moderate disease activity, \<2.7 indicated low disease activity, and \<2.3 indicated remission.
Disease Activity Score (DAS28)-4ESR
Time Frame: Baseline and 24 Weeks
Disease activity score based on 28-joint count and erythrocyte sedimentation rate (4 variables) (DAS28-4 \[ESR\]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, ESR (mm/hour) and visual analogue scale (VAS) of general health assessed by participant or investigator. Higher score indicated more disease activity. The total scale range of DAS28-4 (ESR) , minimum is 0.0 and maximum can not be specified. DAS28-4 (ESR) \>5.1 indicated high disease activity, ?3.2 to ?5.1 indicated moderate disease activity, \<3.2 indicated low disease activity, and \<2.6 indicated remission.
Change From Baseline in Disease Activity Score (DAS28)-4ESR
Time Frame: Baseline and 24 Weeks
Disease activity score based on 28-joint count and erythrocyte sedimentation rate (4 variables) (DAS28-4 \[ESR\]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, ESR (mm/hour) and visual analogue scale (VAS) of general health assessed by participant or investigator. Mean change from baseline in the DAS28-4 (ESR) at Week 24 is calculated. The total scale range can not be specified.
Change From Baseline in Disease Activity Score (DAS28)-4CRP
Time Frame: Baseline and 24 Weeks
Disease activity score based on 28-joint count and C-reactive protein (4 variables) (DAS28-4 \[CRP\]) was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, C-reactive protein (CRP, mg/dL) and VAS of general health. Mean change from baseline in the DAS28-4 (CRP) at Week 24 is calculated. The total scale range can not be specified.
Secondary Outcomes
- Clinical Efficacy Rate(24 Weeks)
- Number of Participants With Treatment Related Pre-specified Important Serious Adverse Events(24 Weeks)
- Number of Participants With Treatment-Related Serious Adverse Events(24 Weeks)