Proof-of-concept study with BMS-817399 to treat moderate to severe rheumatoid arthritis (RA) (clinicaltrials.gov) - Jun 18, 2012 - P2, N=120; Recruiting; Start date: Sep 2011 -> Feb 2011
Start date • Rheumatoid Arthritis
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This study is currently recruiting participants.
Verified March 2012 by Bristol-Myers Squibb
First Received on July 27, 2011. Last Updated on June 18, 2012 History of Changes
Sponsor: Bristol-Myers Squibb
Information provided by (Responsible Party): Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01404585
Purpose
The purpose of this study is to assess whether BMS-817399 in combination with Methotrexate is effective in treating moderate to severe rheumatoid arthritis.
Condition
Rheumatoid Arthritis
Intervention
Drug: Placebo
Drug: BMS-817399
Phase
Phase 2
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BMS-817399 in Adults With Active, Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate
Resource links provided by NLM:
MedlinePlus related topics: Rheumatoid Arthritis
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP) change from baseline of BMS-817399 versus placebo [ Time Frame: Baseline and at 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, physical examinations, and clinical laboratory tests [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
Proportion of subjects achieving 20% American College of Rheumatology (ACR) response in each treatment group [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
Proportion of subjects achieving 20% ACR response in each treatment group [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
Proportion of subjects achieving 20% ACR response in each treatment group [ Time Frame: Day 57 ] [ Designated as safety issue: No ]
Proportion of subjects achieving 20% ACR response in each treatment group [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Proportion of subjects achieving 50% ACR response in each treatment group [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
Proportion of subjects achieving 50% ACR response in each treatment group [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
Proportion of subjects achieving 50% ACR response in each treatment group [ Time Frame: Day 57 ] [ Designated as safety issue: No ]
Proportion of subjects achieving 50% ACR response in each treatment group [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Proportion of subjects achieving 70% ACR response in each treatment group [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
Proportion of subjects achieving 70% ACR response in each treatment group [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
Proportion of subjects achieving 70% ACR response in each treatment group [ Time Frame: Day 57 ] [ Designated as safety issue: No ]
Proportion of subjects achieving 70% ACR response in each treatment group [ Time Frame: Day 85 ] [ Designated as safety issue: No ]
Percent change from baseline in disability index of the Health Assessment Questionnaire (HAQ-DI) [ Time Frame: Baseline and Day 15 ] [ Designated as safety issue: No ]
Percent change from baseline in disability index of the Health Assessment Questionnaire (HAQ-DI) [ Time Frame: Baseline and Day 29 ] [ Designated as safety issue: No ]
Percent change from baseline in disability index of the Health Assessment Questionnaire (HAQ-DI) [ Time Frame: Baseline and Day 57 ] [ Designated as safety issue: No ]
Percent change from baseline in disability index of the Health Assessment Questionnaire (HAQ-DI) [ Time Frame: Baseline and Day 85 ] [ Designated as safety issue: No ]
To assess the minimum observed concentration (Cmin) of BMS-817399 [ Time Frame: Day 15, Day 29, Day 57 and Day 85 ] [ Designated as safety issue: No ]
Estimated Enrollment: 120
Study Start Date: February 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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