Study Evaluating the Safety of Enbrel (Etanercept)
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00683384
First received: May 21, 2008
Last updated: October 15, 2010
Last verified: October 2010
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Purpose
The purpose of this study is to collect post-marketing information on the safety of Enbrel in Filipino patients.
| Condition | Intervention |
|---|---|
|
Arthritis, Psoriatic |
Drug: Etanercept (Enbrel) |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | A Prospective, Observational Study to Monitor Safety in Patients Who Were Administered With Etanercept (Enbrel) 25 mg by Subcutaneous Injection |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- Number of Participants With Spontaneous Adverse Events Reported Until 30 Days After Each Injection [ Time Frame: 30 days post injection up to 3 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 93 |
| Study Start Date: | January 2007 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| 1 | Drug: Etanercept (Enbrel) |
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Primary Care
Criteria
Inclusion Criteria:
- All patients from the study center who received or will receive at least one dose of Enbrel according to the approved product indication.
Exclusion Criteria:
- Previously discontinued Enbrel therapy due to significant safety concern.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
| ClinicalTrials.gov Identifier: | NCT00683384 History of Changes |
| Other Study ID Numbers: | 0881A-102300 |
| Study First Received: | May 21, 2008 |
| Results First Received: | October 15, 2010 |
| Last Updated: | October 15, 2010 |
| Health Authority: | Philippines: Bureau of Food and Drugs |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Arthritis psoriatic |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases TNFR-Fc fusion protein Immunoglobulin G |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013