Arthritis Clinical Trial
Official title:
Enbrel Qw Special Investigation (Regulatory Post Marketing Commitment Plan)
Verified date | November 2013 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Observational |
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.
Status | Completed |
Enrollment | 3 |
Est. completion date | April 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Japan | Taihaku Sakura Hospital | Sendai | Miyagi |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The incidence of adverse events | 12 weeks | Yes | |
Primary | Adverse events not expected from Japanese Package Insert (unknown adverse events) | 12 weeks | Yes | |
Primary | Score of DAS28-4ER (amount of change) | 12 weeks | No | |
Secondary | overall improvement scale (assessed by physician) | 12 weeks | No |
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