Observational Safety Study of Enbrel for Treatment of Psoriasis
This study is ongoing, but not recruiting participants.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00322439
First received: May 5, 2006
Last updated: January 20, 2011
Last verified: January 2011
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Purpose
This is an observational safety study tracking psoriasis subjects on Enbrel for 5 years.
| Condition | Intervention |
|---|---|
|
Psoriasis |
Drug: etanercept Drug: Enbrel |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Observational Post-Marketing Safety Surveillance Registry of Enbrel (Etanercept) for Treatment of Psoriasis |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Assess long-term safety of participating subjects, determine incidence rates of Serious Adverse Events (SAEs) and Serious Infectious Events (SIEs) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Patient- and physician- reported outcomes and healthcare resource use over time [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Whether rates of SAEs, SIEs, and EMIs differ according to (a) prior exposure to systemic therapies or phototherapy, (b) exposure to Enbrel therapy, and (c) presence of certain co-morbid disorders [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Evaluate incidence rates of Events of Medical Interests (EMIs) for participating subjects [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
Whole blood, serum, plasma.
| Enrollment: | 2520 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Observation
Those subjects with plaque psoriasis
|
Drug: etanercept
Subjects will receive at least one dose of prescribed etanercept as per prescribing information for the treatment of plaque psoriasis
Drug: Enbrel
Subjects will receive at least one dose of prescribed Enbrel (etanercept) as per prescribing information for the treatment of plaque psoriasis
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Subjects with plaque psoriasis, who are currently receiving Enbrel or who are intending to start or restart Enbrel therapy at multi-centers.
Criteria
Inclusion Criteria:
- Patients with plaque psoriasis
Exclusion Criteria:
- Prior exposure to any TNF-inhibitor
- Subjects for whom Enbrel is contraindicated
- Subjects currently enrolled in or has not yet completed at least 30 days since ending other investigational drug study
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00322439 History of Changes |
| Other Study ID Numbers: | 20040210 |
| Study First Received: | May 5, 2006 |
| Last Updated: | January 20, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amgen:
|
plaque Psoriasis patients TNF-inhibitor naïve |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases TNFR-Fc fusion protein 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 19, 2013