A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

NCT01241591

Last updated date
Study Location
Centro de Investigaciones Dermatologicas
Ciudad Autonoma de Buenos Aires, C1114aap, , Argentina
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 had a diagnosis of plaque type psoriasis (psoriasis vulgaris);

- Have plaque-type psoriasis covering at least 10% of total body surface area

- Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis

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 systemic and/or topical therapies for the treatment of
psoriasis


- Cannot discontinue phototherapy


- Any uncontrolled significant medical condition

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Official Title  ICMJE A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled, Parallel Group Study Of The Efficacy And Safety Of 2 Oral Doses Of CP- 690,550 And 1 Subcutaneous Dose Of Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Brief Summary To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.
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 5 mg
    CP-690,550 5 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks
  • Drug: CP 690,550 10 mg
    CP-690,550 10 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks
  • Biological: Etanercept 50 mg
    Placebo orally dosed twice daily and etanercept 50 mg subcutaneously dosed twice weekly for 12 weeks
  • Other: Placebo
    Placebo orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks.
Study Arms  ICMJE
  • Experimental: CP 690,550 5 mg BID+Placebo BIW
    Intervention: Drug: CP 690,550 5 mg
  • Experimental: CP 690,550 10 mg BID+Placebo BIW
    Intervention: Drug: CP 690,550 10 mg
  • Active Comparator: Placebo BID+Etanercept 50 mg BIW
    Intervention: Biological: Etanercept 50 mg
  • Placebo Comparator: Placebo BID+Placebo BIW
    Intervention: Other: 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: April 4, 2014)
1101
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2010)
1100
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have had a diagnosis of plaque type psoriasis (psoriasis vulgaris);
  • Have plaque-type psoriasis covering at least 10% of total body surface area
  • Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis

Exclusion Criteria:

  • Non-plaque or drug induced forms of psoriasis
  • Cannot discontinue current systemic and/or topical therapies for the treatment of psoriasis
  • Cannot discontinue phototherapy
  • 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 Argentina,   Austria,   Belgium,   Bosnia and Herzegovina,   Bulgaria,   Chile,   Colombia,   Croatia,   Czechia,   Denmark,   France,   Germany,   Hong Kong,   Hungary,   Israel,   Korea, Republic of,   Netherlands,   Poland,   Russian Federation,   Singapore,   Slovakia,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
Removed Location Countries Czech Republic,   Italy
 
Administrative Information
NCT Number  ICMJE NCT01241591
Other Study ID Numbers  ICMJE A3921080
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 December 2018

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