Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis
NCT00581100
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- 18 years of age or older
- Active, stable plaque psoriasis defined by the following criteria:
- Body surface area (BSA) ≥ 10 % at screening and baseline
- Or, PASI >10 at screening and baseline
- Or, PGA of Psoriasis status of moderate or worse (moderate, marked, or severe) at screening and baseline
- Or, DLQI > 10 at baseline
- Active fingernail psoriasis defined as target fingernail NAPSI ≥ 2 and overall NAPSI > 14 - Target nail is defined as the nail with the highest nail score (matrix+bed scores) at baseline. Should more than one fingernail have the same score, the target fingernail will be chosen by the investigator.
- Failure of at least one systemic psoriasis therapy for nail psoriasis
- Eligible to receive biologic therapy for psoriasis in accordance to local guidelines
- Evidence of Skin conditions other than psoriasis
- Psoralen plus ultraviolet radiation (PUVA), cyclosporine, alefacept, methotrexate,
acitretin, or any other systemic anti-psoriasis therapy within 28 days of study drug
initiation
- Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
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Descriptive Information | ||||
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Brief Title ICMJE | Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis | |||
Official Title ICMJE | Randomised, Open-label Preliminary Study to Assess the Effects of 2 Regimens of Etanercept on Nail and Skin Symptoms in Patients With Nail Psoriasis and Plaque Psoriasis | |||
Brief Summary | The purpose of this study is to evaluate if Etanercept administered at a higher initial dose provides greater improvement in nail and skin psoriasis symptoms than a regimen with a lower initial dose. | |||
Detailed Description | This study will assess the effects of the 2 Etanercept regimens on fingernail psoriasis over 24 weeks among patients with both skin and fingernail symptoms who have previously failed at least one therapy for nail psoriasis. The endpoint of 24 weeks was chosen to allow sufficient time for normal nail growth. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE | Drug: etanercept
Subjects randomized to Arm 1 shall be treated with ETN 50 mg twice weekly for 12 weeks reducing thereafter to ETN 50 mg once weekly to 24 weeks. Subjects randomized to Arm 2 shall be treated with ETN 50 mg once weekly for the entire 24 week treatment period. | |||
Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 136 | |||
Original Estimated Enrollment ICMJE | 120 | |||
Actual Study Completion Date ICMJE | October 2009 | |||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00581100 | |||
Other Study ID Numbers ICMJE | 0881A6-409 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | February 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |