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

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
Radiant Research, Inc.
Birmingham, Alabama, 35209 United States
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

- 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

NCT01276639
Pfizer
Completed
A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis

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A One-Year Study To Evaluate The Effects And Safety Of CP-690,550 In Patients With Moderate To Severe Chronic Plaque Psoriasis
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
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.
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
    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)
  • 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
Papp KA, Menter MA, Abe M, Elewski B, Feldman SR, Gottlieb AB, Langley R, Luger T, Thaci D, Buonanno M, Gupta P, Proulx J, Lan S, Wolk R; OPT Pivotal 1 and OPT Pivotal 2 investigators. Tofacitinib, an oral Janus kinase inhibitor, for the treatment of chronic plaque psoriasis: results from two randomized, placebo-controlled, phase III trials. Br J Dermatol. 2015 Oct;173(4):949-61. doi: 10.1111/bjd.14018.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
901
April 2013
April 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Colombia,   Germany,   Hungary,   Japan,   Mexico,   Poland,   Serbia,   Taiwan,   Ukraine,   United States
 
 
NCT01276639
A3921078
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 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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