A Study to Evaluate the Preliminary Efficacy Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-remitting Multiple Sclerosis
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ClinicalTrials.gov Identifier: NCT00035529 |
Recruitment Status
:
Terminated
First Posted
: May 6, 2002
Last Update Posted
: December 6, 2010
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Sponsor:
Bristol-Myers Squibb
Information provided by:
Bristol-Myers Squibb
Tracking Information | |||
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First Submitted Date ICMJE | May 3, 2002 | ||
First Posted Date ICMJE | May 6, 2002 | ||
Last Update Posted Date | December 6, 2010 | ||
Study Start Date ICMJE | November 2001 | ||
Actual Primary Completion Date | December 2003 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Preliminary efficacy- Reduction in cumulative nr of new or recurrent Gd-enhancing lesions. | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | Complete list of historical versions of study NCT00035529 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE |
Preliminary efficacy: 1) Decrease in annualized relapse rate and 2) Reduction in cumulative nr of new or enlarging T2-weighted MRI lesions. | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | A Study to Evaluate the Preliminary Efficacy Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-remitting Multiple Sclerosis | ||
Official Title ICMJE | A Phase II,Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Preliminary Efficacy, Pharmacokinetics and Immunogenicity of BMS-188667 Administered to Subjects With Relapsing-Remitting Multiple Sclerosis | ||
Brief Summary | The purpose of this study is to determine whether BMS-188667 will decrease multiple sclerosis disease activity on MRI examinations, as well as decrease the rate of clinical MS exacerbations, compared to placebo | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 2 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Multiple Sclerosis | ||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Terminated | ||
Enrollment ICMJE | Not Provided | ||
Original Enrollment ICMJE | Not Provided | ||
Actual Study Completion Date | December 2003 | ||
Actual Primary Completion Date | December 2003 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion
Exclusion
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Sex/Gender |
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Ages | 18 Years to 55 Years (Adult) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00035529 | ||
Other Study ID Numbers ICMJE | IM101-200 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Not Provided | ||
Study Sponsor ICMJE | Bristol-Myers Squibb | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Bristol-Myers Squibb | ||
Verification Date | December 2010 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |