A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis

NCT01276639

Last updated date
Study Location
Radiant Research, Inc.
Birmingham, Alabama, 35209, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Are 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering as least 10%of body surface area

- a Psoriasis Area and Severity Index (PASI) score of 12 and are considered to be candidates for systemic or light therapy

- No evidence of active or latent tuberculosis

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Non-plaque or drug induced forms of psoriasis


- cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot
discontinue phototherapy (PUVA or UVB)


- any uncontrolled significant medical condition

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Advanced Information
Descriptive Information
Brief Title  ICMJE A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis
Official Title  ICMJE Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Brief Summary The main objective of this study is to compare the effects of CP-690,550 with the effects of placebo in patients being treated for moderate to severe chronic plaque psoriasis. This one-year study will also evaluate the safety and tolerability of CP-690,550 versus placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: CP-690,550
    10 mg oral BID, Continuous treatment for 52 Weeks
  • Drug: CP-690,550
    5 mg oral BID, Continuous treatment for 52 Weeks
  • Drug: Placebo/CP-690,550
    0 mg oral BID, Continuous treatment for 16 Weeks; 10 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
  • Drug: Placebo/CP-690,550
    0 mg oral BID, Continuous treatment for 16 Weeks; 5 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
Study Arms  ICMJE
  • Experimental: Active Treatment 10 mg BID
    Intervention: Drug: CP-690,550
  • Experimental: ActiveTreatment 5 mg BID
    Intervention: Drug: CP-690,550
  • Placebo Comparator: Placebo Treatment
    Interventions:
    • Drug: Placebo/CP-690,550
    • Drug: Placebo/CP-690,550
Publications *

*   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
 (submitted: September 18, 2014)
901
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2011)
825
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Are 18 years or older with diagnosis for at least 12 months of moderate to severe plaque psoriasis covering as least 10%of body surface area
  • a Psoriasis Area and Severity Index (PASI) score of 12 and are considered to be candidates for systemic or light therapy
  • No evidence of active or latent tuberculosis

Exclusion Criteria:

  • Non-plaque or drug induced forms of psoriasis
  • cannot discontinue current oral, injectible or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB)
  • any uncontrolled significant medical condition
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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,   Colombia,   Germany,   Hungary,   Japan,   Mexico,   Poland,   Serbia,   Taiwan,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01276639
Other Study ID Numbers  ICMJE A3921078
Has Data Monitoring Committee Yes
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
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP