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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:
Alder Biopharmaceuticals, Inc.
Information provided by (Responsible Party):
Alder Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01373151
First received: June 13, 2011
Last updated: July 24, 2015
Last verified: July 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Rheumatoid Arthritis | Drug: BMS-945429 Placebo Biological: BMS-945429 Drug: Methotrexate Drug: Methotrexate Placebo Drug: Adalimumab Placebo Drug: Adalimumab | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
rheumatoid arthritis
Drug Information available for:
Methotrexate
U.S. FDA Resources
Further study details as provided by Alder Biopharmaceuticals, Inc.:
Primary Outcome Measures:
- Proportion of subjects achieving an American College of Rheumatology (ACR) 20 response rate [ Time Frame: At 12 Weeks ]
Secondary Outcome Measures:
- 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) ]
| Enrollment: | 418 |
| Study Start Date: | June 2011 |
| Study Completion Date: | June 2015 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373151
Show 100 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373151
Show 100 Study Locations
Sponsors and Collaborators
Alder Biopharmaceuticals, Inc.
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Alder Biopharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01373151 History of Changes |
| Other Study ID Numbers: |
IM133-001 2010-023956-99 ( EudraCT Number ) |
| Study First Received: | June 13, 2011 |
| Last Updated: | July 24, 2015 |
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 |
ClinicalTrials.gov processed this record on July 19, 2017