Effectiveness and Safety of 3 Dosing Regimens of CP-690,550 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis
NCT00678210
ABOUT THIS STUDY
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- Have been diagnosed with plaque psoriasis for at least 6 months.
- Have plaque psoriasis covering at least 15% of their total body.
- Be a candidate for phototherapy or systemic treatment of psoriasis (either naïve or history of previous treatment).
- Be willing and able to comply with scheduled visits, treatment plan and other study procedures.
- Currently have non-plaque forms of psoriasis or drug-induced psoriasis.
- Subject cannot discontinue systemic therapies and/or topical therapies for the
treatment of psoriasis and cannot discontinue phototherapy.
- Subject is participating in another trial using an investigational agent or procedure.
- Women who are pregnant or breast-feeding or considering becoming pregnant.
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Descriptive Information | ||||
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Brief Title ICMJE | Effectiveness and Safety of 3 Dosing Regimens of CP-690,550 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis | |||
Official Title ICMJE | A Phase 2B, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial Evaluating The Efficacy And Safety Of Dose Regimens With Oral CP-690,550 In The Treatment Of Subjects With Moderate To Severe Chronic Plaque Psoriasis | |||
Brief Summary | The purpose of this study is to determine the effectiveness and safety, over 12 weeks, of 3 dosing regimens of CP-690,550 for the treatment of adults with moderate to severe chronic plaque psoriasis. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
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 * |
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* 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 | 197 | |||
Original Estimated Enrollment ICMJE | 400 | |||
Actual Study Completion Date ICMJE | August 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 | Canada, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00678210 | |||
Other Study ID Numbers ICMJE | A3921047 | |||
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 | November 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |