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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01373151
First Posted: June 14, 2011
Last Update Posted: September 19, 2017
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.
Information provided by (Responsible Party):
Vitaeris INC
June 13, 2011
June 14, 2011
September 19, 2017
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 ]
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 ]
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 ]
  • Proportion of subjects achieving ACR 50 response rate [ Time Frame: At weeks 12 and 24 ]
  • Proportion of subjects achieving ACR 70 response rate [ Time Frame: At weeks 12 and 24 ]
  • 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 ]
  • Proportion of subjects with remission by DAS28-CRP [ Time Frame: At weeks 12 and 24 ]
  • Mean change from baseline in Clinical Disease Activity Index (CDAI) [ Time Frame: Baseline (Day 1), To weeks 12 and 24 ]
  • Proportion of subjects with remission by CDAI [ Time Frame: At weeks 12 and 24 ]
  • Mean change from baseline in Simplified Disease Activity Index (SDAI) [ Time Frame: Baseline (Day 1), To weeks 12 and 24 ]
  • Proportion of subjects with remission by SDAI [ Time Frame: At weeks 12 and 24 ]
  • Proportion of subjects with remission rate by Boolean definition [ Time Frame: At weeks 12 and 24 ]
  • Mean change from baseline in Health Assessment Questionnaire (HAQ) disability Index [ Time Frame: Baseline (Day 1), To weeks 12 and 24 ]
  • 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 ]
  • Mean change from baseline in fatigue severity (VAS) [ Time Frame: Baseline (Day 1), To weeks 12 and 24 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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) ]
  • 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 ]
    • 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 ]
  • To assess radiographic progression of joint damage by imaging studies: Magnetic resonance imaging (MRI) [ Time Frame: 12 Weeks ]
  • To assess radiographic progression of joint damage by imaging studies: x-ray [ Time Frame: 24 Weeks ]
  • 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 ]
  • 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 ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Weinblatt ME, Mease P, Mysler E, Takeuchi T, Drescher E, Berman A, Xing J, Zilberstein M, Banerjee S, Emery P. The efficacy and safety of subcutaneous clazakizumab in patients with moderate-to-severe rheumatoid arthritis and an inadequate response to methotrexate: results from a multinational, phase IIb, randomized, double-blind, placebo/active-controlled, dose-ranging study. Arthritis Rheumatol. 2015 Oct;67(10):2591-600. doi: 10.1002/art.39249.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
418
June 2015
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Belgium,   Brazil,   Canada,   Czechia,   France,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Russian Federation,   South Africa,   Spain,   Taiwan,   United States
Czech Republic,   Peru
 
NCT01373151
IM133-001
2010-023956-99 ( EudraCT Number )
Yes
Not Provided
Not Provided
Vitaeris INC
Vitaeris INC
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Vitaeris INC
September 2017

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