Enbrel Qw Special Investigation (Regulatory Post Marketing Commitment Plan)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Number of Participants With Treatment Related Adverse Events
Study Overview
Brief Summary
This survey is conducted to investigate safety and efficacy under the post marketed drug utilization on the patient with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy) at the time of switching regimen from 10 mg twice a week administration to 25 mg once a week administration.
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
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients need to be administered etanercept in order to be enrolled in the survey
- •Patients who have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.
Exclusion Criteria
- •Patients who have been administered etanercept 50mg once a week
- •Patients who have been administered etanercept 25mg once a week
Arms & Interventions
Etanercept (genetical recombination)
Among the patients with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy), the patients who will have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.
Intervention: etanercept (genetical recombination) (Drug)
Outcomes
Primary Outcomes
Number of Participants With Treatment Related Adverse Events
Time Frame: 12 weeks
Adverse events are defined as any unfavorable events, including clinically significant abnormal changes in laboratory test values, which develop in participants after the administration of etanercept regardless of the causal relationship to etanercept. The causal relationship between an adverse event and etanercept was evaluated by the sponsor.
Change in Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])
Time Frame: 12 weeks
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) \<2.6 = remission.
Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR])
Time Frame: 12 weeks
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment). Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = remission. DAS28-3 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour). Total score range: 0-9.4, higher score=more disease activity. DAS28-3 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (ESR) \<2.6 = remission.
Secondary Outcomes
- Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values(12 weeks)