Effectiveness and Safety of 3 Dosing Regimens of CP-690,550 to Placebo in Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT00678210

Last updated date
Study Location
Pfizer Investigational Site
Tucson, Arizona, 85710, 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

- 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.

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


- 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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Advanced Information
Descriptive Information
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
  • Drug: CP-690,550
    tablets, 2 mg BID for 12 weeks
  • Drug: CP-690,550
    tablets, 5 mg BID for 12 weeks
  • Drug: CP-690,550
    tablets, 15 mg BID for 12 weeks
  • Drug: Placebo
    tablets, BID for 12 weeks
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: CP-690,550
  • Experimental: 2
    Intervention: Drug: CP-690,550
  • Experimental: 3
    Intervention: Drug: CP-690,550
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
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 14, 2009)
197
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2008)
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:

  • 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.

Exclusion Criteria:

  • 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.
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,   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
Study Director:Pfizer CT.gov Call CenterPfizer
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