Back to resultsPhase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-945429 Placebo
BMS-945429
BMS-945429
BMS-945429
BMS-945429
Methotrexate
Methotrexate
Methotrexate Placebo
Methotrexate
Adalimumab Placebo
Adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility 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
Sites / Locations
- Sun Valley Arthritis Center, Ltd.
- San Diego Arthritis Medical Clinic
- New England Research Associates, Llc
- Quincy Medical Group
- Rockford Orthopedic Associates, Llc.
- Clinical Pharmacology Study Group
- Arthritis Associates Of Mississippi
- Physician Research Collaboration, Llc
- Box Arthritis And Rheumatology Of The Carolinas, Pllc
- Health Research Of Oklahoma
- East Penn Rheumatology Associates, P.C.
- Altoona Center For Clinical Research
- Seattle Rheumatology Associates
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
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- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Centre De Recherche Musculo-Squelettique
- Local Institution
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Description
BMS-945429 Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429 + Methotrexate + Adalimumab Placebo
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
Adalimumab + Methotrexate
Outcomes
Primary Outcome Measures
Percent of Participants Achieving an American College of Rheumatology (ACR) 20% Response Rate
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Secondary Outcome Measures
Percent of Participants With ACR 20 Response
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Percent of Participants Achieving ACR 50 Response Rate
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Percent of Participants Achieving ACR 70 Response Rate
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Mean Change From Baseline in Disease Activity as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission.
Percent of Participants With Remission by DAS28-CRP
DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission.
Mean Change From Baseline in Clinical Disease Activity Index (CDAI)
CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76.
CDAI <= 2.8 = Remission CDAI > 2.8 and <= 10 = Low Disease Activity CDAI > 10 and <= 22 = Moderate Disease Activity CDAI > 22 = High Disease Activity
Percent of Participants With Remission by CDAI
CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76.
CDAI <= 2.8 = Remission CDAI > 2.8 and <= 10 = Low Disease Activity CDAI > 10 and <= 22 = Moderate Disease Activity CDAI > 22 = High Disease Activity
Mean Change From Baseline in Simplified Disease Activity Index (SDAI)
SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86.
0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity
Percent of Participants With Remission by SDAI
SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86.
0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity
Percent of Participants With Remission Rate by Boolean Definition
Boolean-based definition:
At any time point, a patient must satisfy all of the following:
TJC ≤1 (0-28) SJC ≤1 (0-28) CRP ≤1 mg/dl Patient Global Assessment ≤1 (on a 0-10 scale)
Mean Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index
Patients report the amount of difficulty they have in performing 8 categories. Each category is scored on a scale ranging from 0 (performed without any difficulty) to 3 (cannot be done at all). The HAQ-DI is then calculated by summing the scores and dividing by the number of categories answered. Total score is between 0-3.0. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. The HAQ-DI cannot be calculated if the subject does not have scores for at least 6 categories. A response was defined as a subject with a reduction from baseline in HAQ-DI of at least 0.22.
Mean Change From Baseline in Short Form 36 (SF-36) as Measured by Physical and Mental Components
The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.
Mean Change From Baseline in Fatigue Severity (VAS) Score
A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Scores
The WPAI yeilds four types of scores:
Absenteeism (work time missed)
Presenteesism (impairment at work / reduced on-the-job effectiveness)
Work productivty loss (overall work impairment / absenteeism plus presenteeism)
Activity Impairment WPAI outcomes are expressed as impairment percentages with each subscale score ranging from 0-100. The subscale scores are added and averaged to produce a total WPAI score between 0-100. Higher scores indicate greater impairment and less productivity.
Mean Change From Baseline in Radiographic (MRI) Progression of Synovitis, Osteitis (Bone Marrow Edema), Bone Erosion and Cartilage Loss (Joint-space Narrowing)
Mean Change From Baseline in Radiographic (X-ray) Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijde Total Score
The Sharp-van der Heijde total score ranges from 0-528. Scores for erosion range from 0 to 5 in the hands and 0 to 10 in the feet and reflect erosion size, with 0 defined as no erosion and 3 defined as a large erosion passing the midline of the joint. If there is > 1 erosion per joint, scores can be combined to give a maximum score of 5 per joint in the hands and 10 per joint in the feet (a maximum of 5 at each side of the joint). Joint space narrowing scores vary from 0 to 4 in both the hands and feet, with 0 being normal and 4 being the absence of joint space with evident ankylosis or subluxation. Gross osteolysis and pencil-in-cup change are scored separately and, if present, are assigned the maximum score for erosion and joint space narrowing for the same affected joint. Higher scores indicate increased joint damage.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01373151
Brief Title
Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate
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 Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
418 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Placebo Comparator
Arm Description
BMS-945429 Placebo/BMS-945429+Methotrexate+Adalimumab Placebo
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
BMS-945429 + Methotrexate + Adalimumab Placebo
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
BMS-945429 + Methotrexate + Adalimumab Placebo
Arm Title
Arm 4
Arm Type
Experimental
Arm Description
BMS-945429 + Methotrexate + Adalimumab Placebo
Arm Title
Arm 5
Arm Type
Experimental
Arm Description
BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo
Arm Title
Arm 6
Arm Type
Experimental
Arm Description
BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo
Arm Title
Arm 7
Arm Type
Active Comparator
Arm Description
Adalimumab + Methotrexate
Intervention Type
Drug
Intervention Name(s)
BMS-945429 Placebo
Intervention Description
Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
Intervention Type
Biological
Intervention Name(s)
BMS-945429
Intervention Description
Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
Intervention Type
Biological
Intervention Name(s)
BMS-945429
Intervention Description
Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
Intervention Type
Biological
Intervention Name(s)
BMS-945429
Intervention Description
Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
Intervention Type
Biological
Intervention Name(s)
BMS-945429
Intervention Description
Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Tablets, Oral, 15 mg, Weekly, 48 weeks
Intervention Type
Drug
Intervention Name(s)
Methotrexate Placebo
Intervention Description
Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
Intervention Type
Drug
Intervention Name(s)
Adalimumab Placebo
Intervention Description
Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Intervention Description
Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
Primary Outcome Measure Information:
Title
Percent of Participants Achieving an American College of Rheumatology (ACR) 20% Response Rate
Description
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Time Frame
At 12 Weeks
Secondary Outcome Measure Information:
Title
Percent of Participants With ACR 20 Response
Description
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Time Frame
At 24 weeks
Title
Percent of Participants Achieving ACR 50 Response Rate
Description
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Time Frame
At weeks 12 and 24
Title
Percent of Participants Achieving ACR 70 Response Rate
Description
The ACR20/50/70 is a composite measure defined as both improvement of 20%, 50% or 70% in the number of tender and number of swollen joints, and a 20%, 50% or 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP).
Time Frame
At weeks 12 and 24
Title
Mean Change From Baseline in Disease Activity as Measured by Disease Activity Score 28 C-reactive Protein (DAS28-CRP)
Description
DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission.
Time Frame
Baseline, weeks 12 and 24
Title
Percent of Participants With Remission by DAS28-CRP
Description
DAS28-CRP = Disease Activity Scores 28 based on C Reactive Protein. A DAS28-CRP below 2.6 is interpreted as remission.
Time Frame
At weeks 12 and 24
Title
Mean Change From Baseline in Clinical Disease Activity Index (CDAI)
Description
CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76.
CDAI <= 2.8 = Remission CDAI > 2.8 and <= 10 = Low Disease Activity CDAI > 10 and <= 22 = Moderate Disease Activity CDAI > 22 = High Disease Activity
Time Frame
Baseline, weeks 12 and 24
Title
Percent of Participants With Remission by CDAI
Description
CDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (SCJ) (0-28) and tender joint count (TJC) (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity. The CDAI has a range from 0 to 76.
CDAI <= 2.8 = Remission CDAI > 2.8 and <= 10 = Low Disease Activity CDAI > 10 and <= 22 = Moderate Disease Activity CDAI > 22 = High Disease Activity
Time Frame
At weeks 12 and 24
Title
Mean Change From Baseline in Simplified Disease Activity Index (SDAI)
Description
SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86.
0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity
Time Frame
Baseline, weeks 12 and 24
Title
Percent of Participants With Remission by SDAI
Description
SDAI is a composite index for assessing disease activity. CDAI is based on the simple summation of the count of swollen joint count (0-28) and tender joint count (0-28) along with patient global assessment (0-10) Scale and physician global assessment (0-10) for estimating disease activity where 10 means maximal activity and C-reactive protein (0-10). The SDAI has a range from 0 to 86.
0.0 - 3.3 = Remission 3.4 - 11.0 = Low Activity 11.1 - 26.0 = Moderate Activity 26.1 - 86.0 = High Activity
Time Frame
At weeks 12 and 24
Title
Percent of Participants With Remission Rate by Boolean Definition
Description
Boolean-based definition:
At any time point, a patient must satisfy all of the following:
TJC ≤1 (0-28) SJC ≤1 (0-28) CRP ≤1 mg/dl Patient Global Assessment ≤1 (on a 0-10 scale)
Time Frame
At weeks 12 and 24
Title
Mean Change From Baseline in Health Assessment Questionnaire (HAQ) Disability Index
Description
Patients report the amount of difficulty they have in performing 8 categories. Each category is scored on a scale ranging from 0 (performed without any difficulty) to 3 (cannot be done at all). The HAQ-DI is then calculated by summing the scores and dividing by the number of categories answered. Total score is between 0-3.0. Increasing scores indicate worse functioning with 0 indicating no functional impairment and 3 indicating complete impairment. The HAQ-DI cannot be calculated if the subject does not have scores for at least 6 categories. A response was defined as a subject with a reduction from baseline in HAQ-DI of at least 0.22.
Time Frame
Baseline, weeks 12 and 24
Title
Mean Change From Baseline in Short Form 36 (SF-36) as Measured by Physical and Mental Components
Description
The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.
Time Frame
Baseline, weeks 12 and 24
Title
Mean Change From Baseline in Fatigue Severity (VAS) Score
Description
A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.
Time Frame
Baseline, weeks 12 and 24
Title
Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Scores
Description
The WPAI yeilds four types of scores:
Absenteeism (work time missed)
Presenteesism (impairment at work / reduced on-the-job effectiveness)
Work productivty loss (overall work impairment / absenteeism plus presenteeism)
Activity Impairment WPAI outcomes are expressed as impairment percentages with each subscale score ranging from 0-100. The subscale scores are added and averaged to produce a total WPAI score between 0-100. Higher scores indicate greater impairment and less productivity.
Time Frame
Baseline, weeks 12 and 24
Title
Mean Change From Baseline in Radiographic (MRI) Progression of Synovitis, Osteitis (Bone Marrow Edema), Bone Erosion and Cartilage Loss (Joint-space Narrowing)
Time Frame
Baseline and week 12
Title
Mean Change From Baseline in Radiographic (X-ray) Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijde Total Score
Description
The Sharp-van der Heijde total score ranges from 0-528. Scores for erosion range from 0 to 5 in the hands and 0 to 10 in the feet and reflect erosion size, with 0 defined as no erosion and 3 defined as a large erosion passing the midline of the joint. If there is > 1 erosion per joint, scores can be combined to give a maximum score of 5 per joint in the hands and 10 per joint in the feet (a maximum of 5 at each side of the joint). Joint space narrowing scores vary from 0 to 4 in both the hands and feet, with 0 being normal and 4 being the absence of joint space with evident ankylosis or subluxation. Gross osteolysis and pencil-in-cup change are scored separately and, if present, are assigned the maximum score for erosion and joint space narrowing for the same affected joint. Higher scores indicate increased joint damage.
Time Frame
Baseline and week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Sun Valley Arthritis Center, Ltd.
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
San Diego Arthritis Medical Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
New England Research Associates, Llc
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Quincy Medical Group
City
Quincy
State/Province
Illinois
ZIP/Postal Code
62301
Country
United States
Facility Name
Rockford Orthopedic Associates, Llc.
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Arthritis Associates Of Mississippi
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Physician Research Collaboration, Llc
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Box Arthritis And Rheumatology Of The Carolinas, Pllc
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Health Research Of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
East Penn Rheumatology Associates, P.C.
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Seattle Rheumatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1015
Country
Argentina
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Local Institution
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Local Institution
City
San Miguel De Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Local Institution
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Facility Name
Local Institution
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Local Institution
City
Goiania
State/Province
Goias
ZIP/Postal Code
74110
Country
Brazil
Facility Name
Local Institution
City
Juiz De Fora
State/Province
Minas Gerais
ZIP/Postal Code
36010
Country
Brazil
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80060
Country
Brazil
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80440
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91610
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
04032
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
04266
Country
Brazil
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 1S6
Country
Canada
Facility Name
Centre De Recherche Musculo-Squelettique
City
Trois-rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
Local Institution
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Local Institution
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Local Institution
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Local Institution
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Local Institution
City
Chambray Les Tours
ZIP/Postal Code
37170
Country
France
Facility Name
Local Institution
City
Strasbourg Cedex
ZIP/Postal Code
67098
Country
France
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
14059
Country
Germany
Facility Name
Local Institution
City
Koeln
ZIP/Postal Code
50931
Country
Germany
Facility Name
Local Institution
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Local Institution
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Local Institution
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Local Institution
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Local Institution
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Local Institution
City
Chiba-shi
State/Province
Chiba
ZIP/Postal Code
2608712
Country
Japan
Facility Name
Local Institution
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
8078555
Country
Japan
Facility Name
Local Institution
City
Higashi-hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
7390002
Country
Japan
Facility Name
Local Institution
City
Kato-shi
State/Province
Hyogo
ZIP/Postal Code
6731462
Country
Japan
Facility Name
Local Institution
City
Miyazaki-shi
State/Province
Miyazaki
ZIP/Postal Code
8800122
Country
Japan
Facility Name
Local Institution
City
Nagano-shi
State/Province
Nagano
ZIP/Postal Code
3808582
Country
Japan
Facility Name
Local Institution
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
8528501
Country
Japan
Facility Name
Local Institution
City
Sasebo-shi
State/Province
Nagasaki
ZIP/Postal Code
8571195
Country
Japan
Facility Name
Local Institution
City
Tomigusuku-shi
State/Province
Okinawa
ZIP/Postal Code
9010243
Country
Japan
Facility Name
Local Institution
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5458586
Country
Japan
Facility Name
Local Institution
City
Shizuoka-shi
State/Province
Shizuoka
ZIP/Postal Code
4208623
Country
Japan
Facility Name
Local Institution
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
1138519
Country
Japan
Facility Name
Local Institution
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
1608582
Country
Japan
Facility Name
Local Institution
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
1708476
Country
Japan
Facility Name
Local Institution
City
Daegu
ZIP/Postal Code
705-718
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
133-792
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Local Institution
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
42650
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
45040
Country
Mexico
Facility Name
Local Institution
City
Morelia
State/Province
Michioacan
ZIP/Postal Code
58270
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64020
Country
Mexico
Facility Name
Local Institution
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
80230
Country
Mexico
Facility Name
Local Institution
City
San Luis Potosi
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Local Institution
City
Amsterdam
ZIP/Postal Code
1056 AB
Country
Netherlands
Facility Name
Local Institution
City
Katowice
ZIP/Postal Code
40-748
Country
Poland
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
31-531
Country
Poland
Facility Name
Local Institution
City
Poznan
ZIP/Postal Code
60773
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02-118
Country
Poland
Facility Name
Local Institution
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Local Institution
City
Kazan
ZIP/Postal Code
420064
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Local Institution
City
Novosibirsk
ZIP/Postal Code
630005
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
ZIP/Postal Code
191014
Country
Russian Federation
Facility Name
Local Institution
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Local Institution
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0083
Country
South Africa
Facility Name
Local Institution
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0132
Country
South Africa
Facility Name
Local Institution
City
Durban
State/Province
KWA ZULU Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Local Institution
City
Panorama
State/Province
Western CAPE
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Local Institution
City
Pinelands, Cape Town
State/Province
Western Cape
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Local Institution
City
Tygerberg
State/Province
Western CAPE
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Local Institution
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Local Institution
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Local Institution
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Facility Name
Local Institution
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Local Institution
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Local Institution
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
26138593
Citation
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.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
Learn more about this trial
Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate
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