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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

Last updated on November 10, 2018

FOR MORE INFORMATION
Study Location
Centro de Investigaciones Dermatologicas
Ciudad Autonoma de Buenos Aires, C1114aap, Argentina
Contact
1-800-718-1021
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

NCT01241591
Pfizer
Completed
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

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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
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
  • 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.
  • 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


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1101
January 2013
January 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Austria,   Belgium,   Bosnia and Herzegovina,   Bulgaria,   Chile,   Colombia,   Croatia,   Czech Republic,   Denmark,   France,   Germany,   Hong Kong,   Hungary,   Israel,   Korea, Republic of,   Netherlands,   Poland,   Russian Federation,   Singapore,   Slovakia,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
Italy
 
NCT01241591
A3921080
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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