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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00287547
First received: February 6, 2006
Last updated: April 11, 2011
Last verified: April 2011

February 6, 2006
April 11, 2011
March 1997
January 1998   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT00287547 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris
Phase II Randomized, Double-Blind, Placebo-Controlled Study of BMS-188667 (CTLA4Ig) in Patients With Psoriasis Vulgaris

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Psoriasis Vulgaris
Drug: CTLA4Ig / Abatacept
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
144
January 1998
January 1998   (final data collection date for primary outcome measure)

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.)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00287547
IM101-005
Not Provided
Not Provided
Bristol-Myers Squibb
Not Provided
Not Provided
Bristol-Myers Squibb
April 2011

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