Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel (Etanercept) in Psoriasis
This study has been completed.
Sponsor:
Amgen
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00332332
First received: May 30, 2006
Last updated: May 1, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to evaluate the use of Enbrel® (etanercept) in the treatment of psoriasis in patients for a period of up to 1 year.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Biological: ENBREL (entanercept) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel (Etanercept) in Psoriasis |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Status of Mild or Better on Physician Global Assessment at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]Status of mild or better (score of 0, 1 or 2) on the Physician Global Assessment (PGA) at month 12. This scale ranges from 0 to 5, with 0 = best outcome.
Secondary Outcome Measures:
- Percent Change From Baseline to Month 12 in Patient Global Assessment [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]Percent change from baseline to month 12 in the Patient Global Assessment of psoriasis score. This score ranged from 0 (good) to 5 (severe).
- Percent Change From Baseline to Month 12 in Body Surface Area [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]Percent change from baseline to month 12 in body surface area (BSA) affected by psoriasis.
- Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]Percent change from baseline to month 12 in the Dermatology Life Quality Index (DLQI) total score. This score ranges from 0 to 30, with 0 = no effect and 30 = large effect.
| Enrollment: | 246 |
| Study Start Date: | March 2006 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: ENBREL (Etanercept)
OPEN LABEL SINGLE ARM TREATMENT WITH ENBREL (Etanercept)
|
Biological: ENBREL (entanercept)
INTERVENTION WITH ENBREL (Etanercept) IN SUBJECTS WITH PSORIASIS Open label, Enbrel (Etanercept) 50 mg twice weekly SC for 3 months followed by 50 mg twice a week week SC for 9 months, for a total treatment period of 12 months
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years of age or older at baseline
- Moderate to severe plaque psoriasis at baseline with a rating of moderate, marked or severe on the Physician Global Assessment (score of 3, 4 or 5)
- Able to start Enbrel (Etanercept) therapy per the approved product monograph
Contacts and Locations
More Information
Additional Information:
Publications:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00332332 History of Changes |
| Other Study ID Numbers: | 20050180 |
| Study First Received: | May 30, 2006 |
| Results First Received: | November 5, 2010 |
| Last Updated: | May 1, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Amgen:
|
Phase IV Psoriasis Inflammation |
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 23, 2013