N/A
Completed N=3
Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)
Arthritis · Rheumatoid
Source: ClinicalTrials.gov NCT01230177 ↗
Enrolled (actual)
3
Serious AEs
33.3%
Results posted
Feb 2017
Primary outcomePrimary: Number of Participants With Treatment Related Adverse Events — 2 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Related Adverse Events |
2 | — |
| PRIMARY Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR]) |
3.55; 2.72 | — |
| PRIMARY Change in Disease Activity Score of 28 Joints (DAS28: 4/Erythrocyte Sedimentation Rate [ESR]) |
0; -23.58 | — |
| SECONDARY Physician's Assessment of Clinical Effect of Etanercept on the Symptoms of Rheumatoid Arthritis and Change in Laboratory Values |
3; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01230177). 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. Informational only — not medical advice.