Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy
NCT00581555
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- Between age 18 and 70 years
- Active and stable plaque psoriasis with a BSA≥10 or PASI≥10.
- Evidence of skin conditions other than psoriasis
- Psoralen plus psoralen + ultraviolet A (PUVA), ciclosporin, acitretin, alefacept,
anakinra, or any other systemic anti-psoriasis therapy or disease-modifying
antirheumatic drugs (DMARD) with 28 days of screening
- ultraviolet B (UVB) therapy, topical steroids, topical Vitamin A or D analog
preparations, or anthralin
- Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab
- Corticosteroid dose of prednisone >10 mg/day
- Serious infection
- Receipt of any live vaccine
- Abnormal hematology or chemistry
- Body mass index (BMI) > 38
- Pregnancy or Breastfeeding
- Significant concurrent medical conditions
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Descriptive Information | ||||
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Brief Title ICMJE | Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy | |||
Official Title ICMJE | A Randomized Pilot Study Evaluating the Efficacy and Safety of Etanercept in Patients With Moderate to Severe Plaque Psoriasis After Cessation of Ciclosporin Therapy | |||
Brief Summary | The purpose of this study is to evaluate the use of etanercept as a replacement therapy for ciclosporin in patients with plaque psoriasis. | |||
Detailed Description | The purpose of this study is to evaluate the efficacy and safety of etanercept as a replacement therapy for ciclosporin in patients with moderate to severe plaque psoriasis who have achieved an adequate response with ciclosporin. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Psoriasis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Micali G, Wilsmann-Theis D, Mallbris L, Gallo G, Marino V, Brault Y, Germain JM. Etanercept reduces symptoms and severity of psoriasis after cessation of cyclosporine therapy: results of the SCORE study. Acta Derm Venereol. 2015 Jan;95(1):57-61. doi: 10.2340/00015555-1845. | |||
* 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 | 120 | |||
Original Estimated Enrollment ICMJE | 144 | |||
Actual Study Completion Date ICMJE | November 2009 | |||
Actual Primary Completion Date | November 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 to 70 Years (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 | NCT00581555 | |||
Other Study ID Numbers ICMJE | 0881A6-410 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | March 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |