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Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00287547
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : April 25, 2011
Information provided by:
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to assess the safety, pharmacokinetics and clinical activity and immunogenicity of BMS-188667 (CTLA4Ig) in subjects with psoriasis vulgaris

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: CTLA4Ig / Abatacept Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
Study Start Date : March 1997
Actual Primary Completion Date : January 1998
Actual Study Completion Date : January 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Abatacept

Primary Outcome Measures :
  1. Using the Psoriasis Disablity Index (PDI) and other assessment tools to determine if the patient's psoriasis improved or worsened over the course of the study.

Secondary Outcome Measures :
  1. Safety and immunogenicity; pharmacodynamic and PK; Percent reduction in PASI, PASI component scores and Total Body Surface Area; Clinical response kinetics; clinical relapse kinetics; physician global assessment; psoriasis disability index.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis and documentation of a history of stable psoriasis vulgaris of at least 6 months duration.
  • vulgaris total body surfae area involvement of at least 10%
  • Failure for toxicity and/or inefficacy of at least one standard anti- psoriatic therapy including topical treatment, phototherapy, photochemotherapy, methotrexate, cyclosporin A or etretinate.

Exclusion Criteria:

  • Male and female subjects who are not willing to receive adequate counseling and exercise adequate contraceptive measures with enrolle on study.
  • Functional class (V (ACR) RA or amyloidosis)
  • Active vasculitis (except for subcutaneous rheumatoid nodules).
  • Subjects with a history of asthma, angioedema or anaphylaxis.
  • Subjects with evidence of active or latent bacterial or viral invedtions.
  • Subjects with a history or malignancy (except basal cell or superficial squamous cell skin carcinoma).
  • body weight > 100 kg (or 220 lbs.)

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 identifier (NCT number): NCT00287547

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United States, California
Local Institution
San Diego, California, United States
United States, Illinois
Local Institution
Chicago, Illinois, United States
United States, Massachusetts
Local Institution
Boston, Massachusetts, United States
United States, Michigan
Local Institution
Ann Arbor, Michigan, United States
United States, New Jersey
Local Institution
New Brunswick, New Jersey, United States
United States, Oregon
Local Institution
Portland, Oregon, United States
United States, Pennsylvania
Local Institution
Philadelphia, Pennsylvania, United States
United States, Texas
Local Institution
Dallas, Texas, United States
United States, Utah
Local Institution
Salt LAke City, Utah, United States
United States, Vermont
Local Institution
Burlington, Vermont, United States
Sponsors and Collaborators
Bristol-Myers Squibb
Layout table for additonal information Identifier: NCT00287547    
Other Study ID Numbers: IM101-005
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: April 25, 2011
Last Verified: April 2011
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents