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Canadian Assessment of Patient Outcomes and Effectiveness of Etanercept (Enbrel) 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: July 18, 2014
Last verified: July 2014
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Purpose
The purpose of this study is to evaluate the use of etanercept (Enbrel®) in the treatment of psoriasis in patients for a period of up to 1 year.
| Condition | Intervention | Phase |
|---|---|---|
| Psoriasis | Biological: etanercept | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (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:
- Participants With a Status of Mild or Better on Physician Global Assessment at Month 12 [ Time Frame: Month 12 ]The number of participants with a status of mild or better (score of 0, 1 or 2) on the Physician Global Assessment (PGA) of psoriasis 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 ]Percent change from Baseline to Month 12 in the Patient Global Assessment of psoriasis score. This score ranged from 0 (good) to 5 (severe). A negative change from Baseline indicates improvement in disease activity.
- Percent Change From Baseline to Month 12 in Body Surface Area Affected by Psoriasis [ Time Frame: Baseline and Month 12 ]Percent change from Baseline to Month 12 in body surface area (BSA) affected by psoriasis. A reduction (indicated by a negative percent change from Baseline) in the BSA affected is indicative of improvement in disease activity.
- Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score [ Time Frame: Baseline and Month 12 ]Percent change from Baseline to Month 12 in the Dermatology Life Quality Index (DLQI) total score. This score ranges from 0 to 30, where 0 = no effect and 30 = large effect. A reduction in DLQI total score is indicative of improvement in quality of life as it relates to the participant's psoriasis, and a negative change from Baseline indicates improvement.
| 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 |
|---|---|
|
Experimental: etanercept
Open label etanercept 50 mg twice weekly subcutaneously (SC) for 3 months followed by 50 mg twice a week week SC for 9 months, for a total treatment period of 12 months.
|
Biological: etanercept
etanercept subcutaneous injection
Other Name: ENBREL
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Exclusion Criteria
- Active infections at the initiation of Enbrel therapy.
- Evidence of skin conditions (i.e. eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
- Psoralen plus ultraviolet A radiation (PUVA) within 4 weeks or ultraviolet light B (UVB) therapy within 2 weeks of study drug initiation.
- Oral retinoids, cyclosporine, methotrexate, or any other systemic anti-psoriasis therapy within 4 weeks or efalizumab (Raptiva®) within 8 weeks of study drug initiation and during the study period.
- Topical Vitamin A or D analog preparations, or anthralin within 2 weeks of study drug initiation and during the study period.
- Have received Remicade® (infliximab), Humira® (adalimumab) or Amevive®(alefacept) within 3 months before the initiation of study medication or during the study period.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00332332
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332332
Sponsors and Collaborators
Amgen
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | MD | Amgen |
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: | July 18, 2014 |
Keywords provided by Amgen:
|
Phase IV Psoriasis Inflammation |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Etanercept Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Gastrointestinal Agents Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on August 18, 2017