Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01373151
First received: June 13, 2011
Last updated: August 28, 2014
Last verified: July 2014

June 13, 2011
August 28, 2014
June 2011
September 2012   (final data collection date for primary outcome measure)
Proportion of subjects achieving an American College of Rheumatology (ACR) 20 response rate [ Time Frame: At 12 Weeks ] [ Designated as safety issue: No ]
Compare the efficacy of BMS-945429 subcutaneous (SC) vs placebo on a background of Methotrexate (MTX) as assessed by 20% American College of Rheumatology criteria (ACR) response [ Time Frame: At 12 Weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01373151 on ClinicalTrials.gov Archive Site
  • Proportion of subjects with ACR 20 response [ Time Frame: At weeks 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving ACR 50 response rate [ Time Frame: At weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving ACR 70 response rate [ Time Frame: At weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in disease activity as measured by Disease Activity Score 28 C-reactive protein (DAS28-CRP) [ Time Frame: Baseline (Day 1), To weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects with remission by DAS28-CRP [ Time Frame: At weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in Clinical Disease Activity Index (CDAI) [ Time Frame: Baseline (Day 1), To weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects with remission by CDAI [ Time Frame: At weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in Simplified Disease Activity Index (SDAI) [ Time Frame: Baseline (Day 1), To weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects with remission by SDAI [ Time Frame: At weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Proportion of subjects with remission rate by Boolean definition [ Time Frame: At weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in Health Assessment Questionnaire (HAQ) disability Index [ Time Frame: Baseline (Day 1), To weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in Short Form 36 (SF-36) as measured by physical and mental components as well as 8 individual domain scores [ Time Frame: Baseline (Day 1), To weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in fatigue severity (VAS) [ Time Frame: Baseline (Day 1), To weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) as measured by 4 domain scores [ Time Frame: Baseline (Day 1), To weeks 12 and 24 ] [ Designated as safety issue: No ]
  • Mean change from baseline in radiographic progression of synovitis, osteitis (bone marrow edema), bone erosion and cartilage loss (joint-space narrowing) (MRI) [ Time Frame: Baseline (Day 1) and To weeks 12 ] [ Designated as safety issue: No ]
  • Mean change from baseline in radiographic progression of joint damage as measured by modified Sharp/van der Heijide scores (X-ray) [ Time Frame: Baseline (Day 1) and To weeks 24 ] [ Designated as safety issue: No ]
  • Safety will be measured by adverse events, clinically significant changes in vital signs, physical exams and ECG, laboratory test abnormality and immunogenicity changes from baseline [ Time Frame: Upto double-blind period (48 weeks) ] [ Designated as safety issue: Yes ]
  • To assess additional efficacy outcomes of BMS-945429 SC at 12 weeks as measured by ACR50 and 70 response rates, DAS28-CRP, CDAI, SDAI, remission, physical function and health-related quality of life outcomes. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    • ACR20 - 20% American College of Rheumatology (ACR) response
    • ACR50 - 50% American College of Rheumatology (ACR) response
    • ACR70 - 70% American College of Rheumatology (ACR) response
    • DAS28-CRP - Disease Activity Score 28 - C-reactive protein
    • CDAI - Clinical Disease Activity Index
    • SDAI - Simplified Disease Activity Index
  • To assess efficacy of BMS-945429 SC at 24 weeks as measured by ACR 20, 50 and 70 response rates, DAS28-CRP, CDAI, SDAI, remission, physical function and health-related quality of life outcomes. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • To assess radiographic progression of joint damage by imaging studies: Magnetic resonance imaging (MRI) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • To assess radiographic progression of joint damage by imaging studies: x-ray [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • To assess safety and tolerability including immunogenicity rates by the number of adverse events and serious adverse events, laboratory values, physical exams and vital signs, and electrocardiogram (ECG). [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • To assess safety and tolerability including immunogenicity rates by the number of adverse events and serious adverse events, laboratory values, physical exams and vital signs, and electrocardiogram (ECG). [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate
A Phase IIB , Randomized, Multi-Center, Double-Blind, Dose-Ranging, Placebo/Active Controlled Study to Evaluate the Efficacy and Safety of BMS-945429 Subcutaneous Injection With or Without Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Methotrexate.

The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: BMS-945429 Placebo
    Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
  • Biological: BMS-945429
    Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
  • Biological: BMS-945429
    Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
  • Biological: BMS-945429
    Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
  • Biological: BMS-945429
    Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
  • Drug: Methotrexate
    Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
  • Drug: Methotrexate
    Tablets, Oral, 15 mg, Weekly, 48 weeks
  • Drug: Methotrexate Placebo
    Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
  • Drug: Methotrexate
    Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
  • Drug: Adalimumab Placebo
    Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
  • Drug: Adalimumab
    Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
  • Placebo Comparator: Arm 1
    BMS-945429 Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
    Interventions:
    • Drug: BMS-945429 Placebo
    • Biological: BMS-945429
    • Drug: Methotrexate
    • Drug: Adalimumab Placebo
  • Experimental: Arm 2
    BMS-945429 + Methotrexate + Adalimumab Placebo
    Interventions:
    • Biological: BMS-945429
    • Drug: Methotrexate
    • Drug: Adalimumab Placebo
  • Experimental: Arm 3
    BMS-945429 + Methotrexate + Adalimumab Placebo
    Interventions:
    • Biological: BMS-945429
    • Drug: Methotrexate
    • Drug: Adalimumab Placebo
  • Experimental: Arm 4
    BMS-945429 + Methotrexate + Adalimumab Placebo
    Interventions:
    • Biological: BMS-945429
    • Biological: BMS-945429
    • Drug: Methotrexate
    • Drug: Adalimumab Placebo
  • Experimental: Arm 5
    BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
    Interventions:
    • Biological: BMS-945429
    • Drug: Methotrexate Placebo
    • Drug: Methotrexate
    • Drug: Adalimumab Placebo
  • Experimental: Arm 6
    BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
    Interventions:
    • Biological: BMS-945429
    • Drug: Methotrexate Placebo
    • Drug: Methotrexate
    • Drug: Adalimumab Placebo
  • Active Comparator: Arm 7
    Adalimumab + Methotrexate
    Interventions:
    • Drug: Methotrexate
    • Drug: Adalimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
406
August 2020
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Inadequate response to Methotrexate
  • Must have been taking Methotrexate for at least 3 months at a minimal weekly dose of at least 15 mg and stable dose for 4 weeks prior to randomization
  • American College of Rheumatology (ACR) global function status class 1-3
  • Minimum of 6 swollen and 6 tender joints with evidence of synovitis in at least 1 hand or wrist
  • High sensitivity C-reactive protein (hsCRP) ≥ 0.8 mg/dL

Exclusion Criteria:

  • Previously received or currently receiving concomitant biologic therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Belgium,   Brazil,   Canada,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Russian Federation,   South Africa,   Spain,   Taiwan
 
NCT01373151
IM133-001, 2010-023956-99
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2014

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