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

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ClinicalTrials.gov Identifier: NCT00678210
Recruitment Status : Completed
First Posted : May 15, 2008
Results First Posted : December 19, 2012
Last Update Posted : December 19, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Psoriasis Drug: CP-690,550 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: 1 Drug: CP-690,550
tablets, 2 mg BID for 12 weeks

Experimental: 2 Drug: CP-690,550
tablets, 5 mg BID for 12 weeks

Experimental: 3 Drug: CP-690,550
tablets, 15 mg BID for 12 weeks

Placebo Comparator: 4 Drug: Placebo
tablets, BID for 12 weeks




Primary Outcome Measures :
  1. Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score at Week 12 [ Time Frame: Week 12 ]
    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).


Secondary Outcome Measures :
  1. Percentage of Participants Achieving Physician's Global Assessment (PGA) Score of "Clear" or "Almost Clear" [ Time Frame: Week 2, 4, 8, 12, 14, 16 ]
    Physician global assessment of psoriasis is global consideration of the erythema, induration and scaling across all psoriatic lesions, rated separately over the whole body according to a 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the treatment area overall severity of psoriasis score and category. The score of 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.

  2. Percentage of Participants Achieving a 75% Improvement in Psoriasis Area and Severity Index (PASI 75) Score [ Time Frame: Week 2, 4, 8, 14, 16 ]
    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

  3. Percentage of Participants Achieving a 50% Improvement in Psoriasis Area and Severity Index (PASI 50) Score [ Time Frame: Week 2, 4, 8, 12, 14, 16 ]
    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

  4. Percentage of Participants Achieving a 90% Improvement in Psoriasis Area and Severity Index (PASI 90) Score [ Time Frame: Week 12 ]
    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

  5. Psoriasis Area and Severity Index (PASI) Component Scores and Total Score [ Time Frame: Baseline, Week 2, 4, 8, 12, 14, 16 ]
    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%)-6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).

  6. Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores and Total Score at Week 2, 4, 8, 12, 14, and 16 [ Time Frame: Baseline, Week 2, 4, 8, 12, 14, 16 ]
    Combined assessment of lesion severity and area affected into single score; range=0(no disease)-72(maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated:0(0%) - 6(90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor(head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678210


Locations
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United States, Arizona
Pfizer Investigational Site
Tucson, Arizona, United States, 85710
United States, Arkansas
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Pfizer Investigational Site
Oceanside, California, United States, 92056
United States, Florida
Pfizer Investigational Site
Jacksonville, Florida, United States, 32204
Pfizer Investigational Site
Miami, Florida, United States, 33144
United States, Illinois
Pfizer Investigational Site
West Dundee, Illinois, United States, 60118
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02111
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01610
United States, Missouri
Pfizer Investigational Site
Saint Louis, Missouri, United States, 63117
United States, New Jersey
Pfizer Investigational Site
East Windsor, New Jersey, United States, 08520
Pfizer Investigational Site
Paramus, New Jersey, United States, 07652
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10016
Pfizer Investigational Site
Rochester, New York, United States, 14623
United States, North Carolina
Pfizer Investigational Site
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Pfizer Investigational Site
Norman, Oklahoma, United States, 73069
United States, Oregon
Pfizer Investigational Site
Lake Oswego, Oregon, United States, 97035
Pfizer Investigational Site
Portland, Oregon, United States, 97210
Pfizer Investigational Site
Portland, Oregon, United States, 97223
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Pfizer Investigational Site
Greer, South Carolina, United States, 29650
Pfizer Investigational Site
Greer, South Carolina, United States, 29651
Pfizer Investigational Site
Mt. Pleasant, South Carolina, United States, 29464
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75246
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
Webster, Texas, United States, 77598
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84132
United States, Virginia
Pfizer Investigational Site
Norfolk, Virginia, United States, 23507
Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V5Z 4E8
Canada, New Brunswick
Pfizer Investigational Site
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Newfoundland and Labrador
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, Canada, A1C 2H5
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 1V7
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 1Y6
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 1Z4
Canada, Ontario
Pfizer Investigational Site
Barrie, Ontario, Canada, L4M 6L2
Pfizer Investigational Site
London, Ontario, Canada, N5X 2P1
Pfizer Investigational Site
North Bay, Ontario, Canada, P1B 3Z7
Pfizer Investigational Site
Waterloo, Ontario, Canada, N2J 1C4
Pfizer Investigational Site
Windsor, Ontario, Canada, N8W 5L7
Canada, Quebec
Pfizer Investigational Site
Laval, Quebec, Canada, H7S 2C6
Pfizer Investigational Site
Montreal, Quebec, Canada, H2K 4L5
Pfizer Investigational Site
Montreal, Quebec, Canada, H3Z 2S6
Canada
Pfizer Investigational Site
Quebec, Canada, G1V 4X7
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00678210    
Other Study ID Numbers: A3921047
First Posted: May 15, 2008    Key Record Dates
Results First Posted: December 19, 2012
Last Update Posted: December 19, 2012
Last Verified: November 2012
Keywords provided by Pfizer:
dose response; PASI 75 response endpoint; subjects with moderate to severe chronic plaque psoriasis
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action