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

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ClinicalTrials.gov Identifier: NCT01373151
Recruitment Status : Completed
First Posted : June 14, 2011
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Vitaeris INC

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: BMS-945429 Placebo Biological: BMS-945429 Drug: Methotrexate Drug: Methotrexate Placebo Drug: Adalimumab Placebo Drug: Adalimumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : June 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Arm 1
BMS-945429 Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
 Drug: BMS-945429 Placebo
Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
Biological: BMS-945429
Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Drug: Methotrexate
Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Drug: Adalimumab Placebo
Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
Experimental: Arm 2
BMS-945429 + Methotrexate + Adalimumab Placebo
 Biological: BMS-945429
Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Drug: Methotrexate
Tablets, Oral, 15 mg, Weekly, 48 weeks
Drug: Adalimumab Placebo
Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
Experimental: Arm 3
BMS-945429 + Methotrexate + Adalimumab Placebo
 Biological: BMS-945429
Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Drug: Methotrexate
Tablets, Oral, 15 mg, Weekly, 48 weeks
Drug: Adalimumab Placebo
Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
Experimental: Arm 4
BMS-945429 + Methotrexate + Adalimumab Placebo
 Biological: BMS-945429
Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
Biological: BMS-945429
Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Drug: Methotrexate
Tablets, Oral, 15 mg, Weekly, 48 weeks
Drug: Adalimumab Placebo
Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
Experimental: Arm 5
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
 Biological: BMS-945429
Injection, Subcutaneous, 200 mg, Every 4 weeks, 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
Experimental: Arm 6
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
 Biological: BMS-945429
Injection, Subcutaneous, 100 mg, Every 4 weeks, 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
Active Comparator: Arm 7
Adalimumab + Methotrexate
 Drug: Methotrexate
Tablets, Oral, 15 mg, Weekly, 48 weeks
Drug: Adalimumab
Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of subjects achieving an American College of Rheumatology (ACR) 20 response rate [ Time Frame: At 12 Weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects with ACR 20 response [ Time Frame: At weeks 24 ]
  2. Proportion of subjects achieving ACR 50 response rate [ Time Frame: At weeks 12 and 24 ]
  3. Proportion of subjects achieving ACR 70 response rate [ Time Frame: At weeks 12 and 24 ]
  4. 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 ]
  5. Proportion of subjects with remission by DAS28-CRP [ Time Frame: At weeks 12 and 24 ]
  6. Mean change from baseline in Clinical Disease Activity Index (CDAI) [ Time Frame: Baseline (Day 1), To weeks 12 and 24 ]
  7. Proportion of subjects with remission by CDAI [ Time Frame: At weeks 12 and 24 ]
  8. Mean change from baseline in Simplified Disease Activity Index (SDAI) [ Time Frame: Baseline (Day 1), To weeks 12 and 24 ]
  9. Proportion of subjects with remission by SDAI [ Time Frame: At weeks 12 and 24 ]
  10. Proportion of subjects with remission rate by Boolean definition [ Time Frame: At weeks 12 and 24 ]
  11. Mean change from baseline in Health Assessment Questionnaire (HAQ) disability Index [ Time Frame: Baseline (Day 1), To weeks 12 and 24 ]
  12. 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 ]
  13. Mean change from baseline in fatigue severity (VAS) [ Time Frame: Baseline (Day 1), To weeks 12 and 24 ]
  14. 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 ]
  15. 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 ]
  16. 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 ]
  17. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01373151


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Sponsors and Collaborators
Vitaeris INC
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Vitaeris INC
ClinicalTrials.gov Identifier: NCT01373151     History of Changes
Other Study ID Numbers: IM133-001
2010-023956-99 ( EudraCT Number )
First Posted: June 14, 2011    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Adalimumab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
 Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents