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Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy

Primary Purpose

Polymyositis, Dermatomyositis, Autoimmune Necrotizing Myopathy

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Abatacept subcutaneous
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polymyositis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Diagnosis of IIM based on the Bohan and Peter classification criteria: i) Subjects with dermatomyositis (DM) must also have a confirmed myositis-associated rash (Gottron's papules or a heliotrope rash preferably confirmed by skin biopsy) and 2 or more of the remaining 4 criteria.

ii) Subjects with a diagnosis of IIM other than DM include PM, autoimmune necrotizing myopathy, myositis in association with another connective tissue disease (overlap myositis) and juvenile myositis subjects above the age of 18. These subjects must have a prior muscle biopsy diagnostic for IIM or a positive test for at least one myositis-specific autoantibody (anti-aminoacyl-tRNA synthetases (Jo-1, PL-7, PL-12, EJ, OJ, KS, Zo, YRS), anti-Mi-2, anti-SRP, anti-TIF1-g, anti-NXP-2, anti-MDA5, anti-SAE, anti-HMGCR). For subjects with overlap myositis, the myositis must be the principal clinically active manifestation of their disease. Where applicable, documentation of prior skin biopsy, muscle biopsy, and autoantibody results must be obtained and retained by the site.

  • Demonstrable muscle weakness measured by the MMT-8 of ≤ 135 units and any 3 of the following: i) MMT-8 ≤ 125 units; ii) Physician's global assessment (PGA) visual analog scale (VAS) ≥2 cm; iii) Subject's global assessment (SGA) VAS ≥2 cm; iv) HAQ-DI ≥ 0.5; v) One or more muscle enzyme (CK, aldolase, LDH, AST, ALT) ³ 1.3 times upper limit of normal (ULN); vi) MDAAT Extramuscular Global Activity VAS ≥2 cm
  • Demonstration of currently active IIM will be determined by an adjudication committee unless the subject has any one of the following: i) an active myositis-associated rash (Gottron's papules or heliotrope rash), or ii) a recent (within 3 months prior to signing informed consent) biopsy, magnetic resonance imaging (MRI), or electromyogram (EMG) demonstrating active disease, or iii) an elevated CK > 5 times the upper limit of normal
  • Active disease despite prior treatment with corticosteroids, immunosuppressants, or biologics as determined by the investigator
  • The subject must be on background standard treatment for IIM. The standard treatments that are allowed as background treatment for IIM includes: i) Corticosteroids alone, or ii) One of the following immunosuppressants: methotrexate, azathioprine, mycophenolate mofetil, tacrolimus, or cyclosporine (combinations of these treatments are not allowed), or iii) A combination of corticosteroids and one of the above immunosuppressants. The subject must have been on the same medication(s) for IIM for 12 weeks prior to randomization and the dose must have been stable for 4 weeks prior to randomization. If using azathioprine, the subject must have been on azathioprine for at least 24 weeks with a stable dose for at least 12 weeks prior to randomization.

Exclusion Criteria:

  • Subjects with Inclusion Body Myositis (IBM), or myositis other than IIM, eg, drug-induced myositis and PM associated with HIV
  • Subjects treated with penicillamine or zidovudine in the past 3 months
  • Subjects treated with rituximab in the 6 months prior to randomization (there must be laboratory results indicating the presence of circulating B cells [CD19+]). Any other biologic treatment in the past 3 months or immune globulin (intravenous [IVIG] or subcutaneous [SCIG]) in the past 3 months prior to randomization
  • Subjects with uncontrolled or rapidly progressive interstitial lung disease
  • Subjects with severe muscle damage (Myositis Damage Index > 7/10), permanent weakness due to a non-IIM cause, or myositis with cardiac involvement
  • Cancer-associated myositis (myositis diagnosed within 2 years of a diagnosis of cancer
  • Subjects who are known to be positive for the anti-TIF-1 (p155/140) autoantibody prior to randomization who were diagnosed with IIM < 1 year prior to randomization.
  • Subjects at risk for tuberculosis
  • Subjects with recent acute infection requiring antibiotics
  • Subjects with history of chronic or recurrent bacterial, viral or systemic fungal infections
  • Subjects who have a present malignancy or have had a previous malignancy within the last 5 years prior to screening (except for a documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ).

Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

  • Local Institution - 0015
  • Local Institution - 0075
  • Local Institution - 0012
  • Local Institution - 0057
  • Local Institution - 0018
  • Local Institution - 0013
  • Local Institution - 0006
  • Local Institution - 0058
  • Local Institution - 0089
  • Local Institution - 0002
  • Local Institution - 0011
  • Local Institution - 0004
  • Local Institution - 0097
  • Local Institution - 0010
  • Local Institution - 0056
  • Local Institution - 0094
  • Local Institution - 0059
  • Local Institution - 0055
  • Local Institution - 0014
  • Local Institution - 0005
  • Local Institution - 0017
  • Local Institution - 0096
  • Local Institution - 0016
  • Local Institution - 0095
  • Local Institution - 0051
  • Local Institution - 0053
  • Local Institution - 0035
  • Local Institution - 0036
  • Local Institution - 0073
  • Local Institution - 0070
  • Local Institution - 0069
  • Local Institution - 0072
  • Local Institution - 0074
  • Local Institution - 0067
  • Local Institution - 0071
  • Local Institution - 0029
  • Local Institution - 0100
  • Local Institution - 0045
  • Local Institution - 0043
  • Local Institution - 0042
  • Local Institution - 0044
  • Local Institution - 0027
  • Local Institution - 0054
  • Local Institution - 0028
  • Local Institution - 0030
  • Local Institution - 0023
  • Local Institution - 0031
  • Local Institution - 0024
  • Local Institution - 0020
  • Local Institution - 0025
  • Local Institution - 0091
  • Local Institution - 0090
  • Local Institution - 0078
  • Local Institution - 0082
  • Local Institution - 0083
  • Local Institution - 0084
  • Local Institution - 0088
  • Local Institution
  • Local Institution - 0077
  • Local Institution - 0086
  • Local Institution - 0079
  • Local Institution - 0081
  • Local Institution - 0092
  • Local Institution - 0093
  • Local Institution - 0087
  • Local Institution - 0076
  • Local Institution - 0066
  • Local Institution - 0065
  • Local Institution - 0064
  • Local Institution - 0049
  • Local Institution - 0046
  • Local Institution - 0048
  • Local Institution - 0047
  • Local Institution - 0052
  • Local Institution - 0040
  • Local Institution - 0041
  • Local Institution - 0037
  • Local Institution - 0038

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Abatacept subcutaneous + Standard Treatment

Placebo of Abatacept subcutaneous + Standard Treatment

Arm Description

Abatacept subcutaneous weekly in addition to the subject's current standard treatment for 24 weeks followed by a 28 week open-label period of abatacept treatment plus the subject's current standard treatment.

Placebo of Abatacept subcutaneous weekly in addition to the subject's current standard treatment for 24 weeks followed by a 28 week open-label period of abatacept treatment plus the subject's current standard treatment.

Outcomes

Primary Outcome Measures

Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue
The number of participants who achieve IMACS DOI (International Myositis Assessment and Clinical Studies definition of improvement) without rescue medication at week 24. The IMACS DOI is: An improvement of >/= 20% from baseline in 3 IMACS core measures, no more than 2 IMACS core measure scores worsen by >/= 25% from baseline, and no more than 2 IMACS core measure scores worsen by >/= 25% from baseline. IMACS core measures are: Physician Global Assessment of Disease Activity (PGA), Patient (Subject) Global Assessment of Disease Activity (SGA), Manual Muscle Test (MMT-8), Health Assessment Questionnaire-Disability Index (HAQ-DI), Muscle Enzyme levels, Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity.

Secondary Outcome Measures

Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24.
The adjusted mean change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI). HAQ-DI is a patient-reported outcome measuring disability by asking a total of 20 questions in eight categories of function: dressing, arising, eating, walking, hygiene, reach, grip, and activities. If an aid or device is used or if help is required from another individual, then the minimum score for that section is 2. The highest component score in each category determines the score for the category and scores are averaged to give the disability index. The HAQ scale ranges from 0 (no difficulties) to 3 (unable to do).
Mean Change in Muscle Endurance Using the Myositis Function Index (FI-2) From Baseline to Week 24
The adjusted mean change from baseline in Myositis FI-2 scores is assessing muscle endurance impairment by testing specific muscle groups. The 3 Score average includes shoulder flexion, hip flexion, and head lift. Each muscle group is scored as the number of correctly performed repetitions with 60 maximal number of repetitions. The total score is based on hip flexion, shoulder flexion (R/L) and neck divided by 3 (range 0-60 repetitions).
Mean Change in Myositis Disease Activity Assessment Tool (MDAAT) Assessment of Extra-muscular From Baseline to Week 24.
The adjusted mean change from baseline in the Myositis Disease Activity Assessment Tool (MDAAT) assessment of extra-muscular uses a 100 mm Visual Analog Scale (VAS) scale. This VAS assesses the overall extra-muscular clinical features based upon: 1) The presence of clinical features or symptoms within the previous 4 weeks that are due to active disease. 2) The judgment that the feature is due to the myositis disease process. 3) The concept that disease activity is defined as a potentially reversible finding. 4) A clinical, functional, and laboratory assessments. The scoring is performed by the investigator and ranges from 0 (absent extra-muscular disease activity) to 100 (maximum extra-muscular disease activity).
Myositis Response Criteria (MRC) Total Improvement Score From Baseline to Week 24.
The Myositis Response Criteria (MRC) is a continuous total improvement score from baseline (range 0-100) based on the sum of the absolute percent change in the 6 core domains (weighted) used in the IMACS DOI (International Myositis Assessment and Clinical Studies definition of improvement) IMACS core measures are: Physician Global Assessment of Disease Activity (PGA), Patient (Subject) Global Assessment of Disease Activity (SGA), Manual Muscle Test (MMT-8), Health Assessment Questionnaire-Disability Index (HAQ-DI), Muscle Enzyme levels, Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity. The total improvement score ranges between 0 and 100 percent corresponds to the degree of improvement, with higher scores corresponding to a greater degree of improvement ( >/= 20 represents minimal improvement, a score of >/= 40 represents moderate improvement, and a score of >/= 60 represents major improvement).
Number of Participants Experiencing Adverse Events (AE) in the Double-Blind Period
The number of treated participants experiencing an adverse event. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants administered a study drug and that does not necessarily have a causal relationship with the treatment.
Number of Participants Experiencing Serious Adverse Events (SAE) in the Double-Blind Period
The number of treated participants experiencing a Serious Adverse Event (SAE). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Number of Participants Experiencing Adverse Events (AE) of Special Interest in the Double-Blind Period
The number of treated participants experiencing adverse events of special interest: infections, malignancies, autoimmune events, local injection site reactions, and systemic injection reactions.
Number of Participants Experiencing Laboratory Test Abnormalities in the Double-Blind Period
The number of participants experiencing laboratory test abnormalities. Laboratory analysis was performed on the following: hematology, liver and kidney function, electrolytes, other chemistry testing (glucose, protein, cardiac), and urine chemistry. Only tests with participants experiencing abnormalities were reported.

Full Information

First Posted
November 21, 2016
Last Updated
June 29, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02971683
Brief Title
Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy
Official Title
A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC With Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy (IIM)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Inability to meet protocol objectives
Study Start Date
May 4, 2017 (Actual)
Primary Completion Date
July 27, 2020 (Actual)
Study Completion Date
August 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Trial to Evaluate the Efficacy and Safety of Abatacept subcutaneous (SC) in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polymyositis, Dermatomyositis, Autoimmune Necrotizing Myopathy, Overlap Myositis, Juvenile Myositis Above the Age of 18

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abatacept subcutaneous + Standard Treatment
Arm Type
Active Comparator
Arm Description
Abatacept subcutaneous weekly in addition to the subject's current standard treatment for 24 weeks followed by a 28 week open-label period of abatacept treatment plus the subject's current standard treatment.
Arm Title
Placebo of Abatacept subcutaneous + Standard Treatment
Arm Type
Placebo Comparator
Arm Description
Placebo of Abatacept subcutaneous weekly in addition to the subject's current standard treatment for 24 weeks followed by a 28 week open-label period of abatacept treatment plus the subject's current standard treatment.
Intervention Type
Drug
Intervention Name(s)
Abatacept subcutaneous
Intervention Description
Specified dose of Abatacept subcutaneous on specified days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo of Abatacept subcutaneous
Primary Outcome Measure Information:
Title
Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue
Description
The number of participants who achieve IMACS DOI (International Myositis Assessment and Clinical Studies definition of improvement) without rescue medication at week 24. The IMACS DOI is: An improvement of >/= 20% from baseline in 3 IMACS core measures, no more than 2 IMACS core measure scores worsen by >/= 25% from baseline, and no more than 2 IMACS core measure scores worsen by >/= 25% from baseline. IMACS core measures are: Physician Global Assessment of Disease Activity (PGA), Patient (Subject) Global Assessment of Disease Activity (SGA), Manual Muscle Test (MMT-8), Health Assessment Questionnaire-Disability Index (HAQ-DI), Muscle Enzyme levels, Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity.
Time Frame
From first dose to 24 weeks after first dose. (Approximately 169 days)
Secondary Outcome Measure Information:
Title
Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24.
Description
The adjusted mean change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI). HAQ-DI is a patient-reported outcome measuring disability by asking a total of 20 questions in eight categories of function: dressing, arising, eating, walking, hygiene, reach, grip, and activities. If an aid or device is used or if help is required from another individual, then the minimum score for that section is 2. The highest component score in each category determines the score for the category and scores are averaged to give the disability index. The HAQ scale ranges from 0 (no difficulties) to 3 (unable to do).
Time Frame
From first dose to 24 weeks after first dose. (Approximately 169 days)
Title
Mean Change in Muscle Endurance Using the Myositis Function Index (FI-2) From Baseline to Week 24
Description
The adjusted mean change from baseline in Myositis FI-2 scores is assessing muscle endurance impairment by testing specific muscle groups. The 3 Score average includes shoulder flexion, hip flexion, and head lift. Each muscle group is scored as the number of correctly performed repetitions with 60 maximal number of repetitions. The total score is based on hip flexion, shoulder flexion (R/L) and neck divided by 3 (range 0-60 repetitions).
Time Frame
From first dose to 24 weeks after first dose. (Approximately 169 days)
Title
Mean Change in Myositis Disease Activity Assessment Tool (MDAAT) Assessment of Extra-muscular From Baseline to Week 24.
Description
The adjusted mean change from baseline in the Myositis Disease Activity Assessment Tool (MDAAT) assessment of extra-muscular uses a 100 mm Visual Analog Scale (VAS) scale. This VAS assesses the overall extra-muscular clinical features based upon: 1) The presence of clinical features or symptoms within the previous 4 weeks that are due to active disease. 2) The judgment that the feature is due to the myositis disease process. 3) The concept that disease activity is defined as a potentially reversible finding. 4) A clinical, functional, and laboratory assessments. The scoring is performed by the investigator and ranges from 0 (absent extra-muscular disease activity) to 100 (maximum extra-muscular disease activity).
Time Frame
From first dose to 24 weeks after first dose. (Approximately 169 days)
Title
Myositis Response Criteria (MRC) Total Improvement Score From Baseline to Week 24.
Description
The Myositis Response Criteria (MRC) is a continuous total improvement score from baseline (range 0-100) based on the sum of the absolute percent change in the 6 core domains (weighted) used in the IMACS DOI (International Myositis Assessment and Clinical Studies definition of improvement) IMACS core measures are: Physician Global Assessment of Disease Activity (PGA), Patient (Subject) Global Assessment of Disease Activity (SGA), Manual Muscle Test (MMT-8), Health Assessment Questionnaire-Disability Index (HAQ-DI), Muscle Enzyme levels, Myositis Disease Activity Assessment Tool (MDAAT) Extramuscular Global Activity. The total improvement score ranges between 0 and 100 percent corresponds to the degree of improvement, with higher scores corresponding to a greater degree of improvement ( >/= 20 represents minimal improvement, a score of >/= 40 represents moderate improvement, and a score of >/= 60 represents major improvement).
Time Frame
From first dose to 24 weeks after first dose. (Approximately 169 days)
Title
Number of Participants Experiencing Adverse Events (AE) in the Double-Blind Period
Description
The number of treated participants experiencing an adverse event. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in participants administered a study drug and that does not necessarily have a causal relationship with the treatment.
Time Frame
From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period.
Title
Number of Participants Experiencing Serious Adverse Events (SAE) in the Double-Blind Period
Description
The number of treated participants experiencing a Serious Adverse Event (SAE). A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
Time Frame
From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period.
Title
Number of Participants Experiencing Adverse Events (AE) of Special Interest in the Double-Blind Period
Description
The number of treated participants experiencing adverse events of special interest: infections, malignancies, autoimmune events, local injection site reactions, and systemic injection reactions.
Time Frame
From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period.
Title
Number of Participants Experiencing Laboratory Test Abnormalities in the Double-Blind Period
Description
The number of participants experiencing laboratory test abnormalities. Laboratory analysis was performed on the following: hematology, liver and kidney function, electrolytes, other chemistry testing (glucose, protein, cardiac), and urine chemistry. Only tests with participants experiencing abnormalities were reported.
Time Frame
From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -Diagnosis of IIM based on the Bohan and Peter classification criteria: i) Subjects with dermatomyositis (DM) must also have a confirmed myositis-associated rash (Gottron's papules or a heliotrope rash preferably confirmed by skin biopsy) and 2 or more of the remaining 4 criteria. ii) Subjects with a diagnosis of IIM other than DM include PM, autoimmune necrotizing myopathy, myositis in association with another connective tissue disease (overlap myositis) and juvenile myositis subjects above the age of 18. These subjects must have a prior muscle biopsy diagnostic for IIM or a positive test for at least one myositis-specific autoantibody (anti-aminoacyl-tRNA synthetases (Jo-1, PL-7, PL-12, EJ, OJ, KS, Zo, YRS), anti-Mi-2, anti-SRP, anti-TIF1-g, anti-NXP-2, anti-MDA5, anti-SAE, anti-HMGCR). For subjects with overlap myositis, the myositis must be the principal clinically active manifestation of their disease. Where applicable, documentation of prior skin biopsy, muscle biopsy, and autoantibody results must be obtained and retained by the site. Demonstrable muscle weakness measured by the MMT-8 of ≤ 135 units and any 3 of the following: i) MMT-8 ≤ 125 units; ii) Physician's global assessment (PGA) visual analog scale (VAS) ≥2 cm; iii) Subject's global assessment (SGA) VAS ≥2 cm; iv) HAQ-DI ≥ 0.5; v) One or more muscle enzyme (CK, aldolase, LDH, AST, ALT) ³ 1.3 times upper limit of normal (ULN); vi) MDAAT Extramuscular Global Activity VAS ≥2 cm Demonstration of currently active IIM will be determined by an adjudication committee unless the subject has any one of the following: i) an active myositis-associated rash (Gottron's papules or heliotrope rash), or ii) a recent (within 3 months prior to signing informed consent) biopsy, magnetic resonance imaging (MRI), or electromyogram (EMG) demonstrating active disease, or iii) an elevated CK > 5 times the upper limit of normal Active disease despite prior treatment with corticosteroids, immunosuppressants, or biologics as determined by the investigator The subject must be on background standard treatment for IIM. The standard treatments that are allowed as background treatment for IIM includes: i) Corticosteroids alone, or ii) One of the following immunosuppressants: methotrexate, azathioprine, mycophenolate mofetil, tacrolimus, or cyclosporine (combinations of these treatments are not allowed), or iii) A combination of corticosteroids and one of the above immunosuppressants. The subject must have been on the same medication(s) for IIM for 12 weeks prior to randomization and the dose must have been stable for 4 weeks prior to randomization. If using azathioprine, the subject must have been on azathioprine for at least 24 weeks with a stable dose for at least 12 weeks prior to randomization. Exclusion Criteria: Subjects with Inclusion Body Myositis (IBM), or myositis other than IIM, eg, drug-induced myositis and PM associated with HIV Subjects treated with penicillamine or zidovudine in the past 3 months Subjects treated with rituximab in the 6 months prior to randomization (there must be laboratory results indicating the presence of circulating B cells [CD19+]). Any other biologic treatment in the past 3 months or immune globulin (intravenous [IVIG] or subcutaneous [SCIG]) in the past 3 months prior to randomization Subjects with uncontrolled or rapidly progressive interstitial lung disease Subjects with severe muscle damage (Myositis Damage Index > 7/10), permanent weakness due to a non-IIM cause, or myositis with cardiac involvement Cancer-associated myositis (myositis diagnosed within 2 years of a diagnosis of cancer Subjects who are known to be positive for the anti-TIF-1 (p155/140) autoantibody prior to randomization who were diagnosed with IIM < 1 year prior to randomization. Subjects at risk for tuberculosis Subjects with recent acute infection requiring antibiotics Subjects with history of chronic or recurrent bacterial, viral or systemic fungal infections Subjects who have a present malignancy or have had a previous malignancy within the last 5 years prior to screening (except for a documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Other protocol-defined inclusion/exclusion criteria apply
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
Local Institution - 0015
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Facility Name
Local Institution - 0075
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Local Institution - 0012
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Local Institution - 0057
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Local Institution - 0018
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
Local Institution - 0013
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Local Institution - 0006
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Local Institution - 0058
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Local Institution - 0089
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Local Institution - 0002
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Facility Name
Local Institution - 0011
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-3025
Country
United States
Facility Name
Local Institution - 0004
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Local Institution - 0097
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Local Institution - 0010
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Local Institution - 0056
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
Local Institution - 0094
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Local Institution - 0059
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73072
Country
United States
Facility Name
Local Institution - 0055
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Local Institution - 0014
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Local Institution - 0005
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Local Institution - 0017
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Local Institution - 0096
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Local Institution - 0016
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution - 0095
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Local Institution - 0051
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Local Institution - 0053
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Local Institution - 0035
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Local Institution - 0036
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Local Institution - 0073
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40150150
Country
Brazil
Facility Name
Local Institution - 0070
City
Vitoria
State/Province
Espirito Santo
ZIP/Postal Code
29055-450
Country
Brazil
Facility Name
Local Institution - 0069
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36010570
Country
Brazil
Facility Name
Local Institution - 0072
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90480-000
Country
Brazil
Facility Name
Local Institution - 0074
City
Bairro Jardim
State/Province
SAO Paulo
ZIP/Postal Code
09090-790
Country
Brazil
Facility Name
Local Institution - 0067
City
Rio Grande Do Sul
ZIP/Postal Code
90035-000
Country
Brazil
Facility Name
Local Institution - 0071
City
Sao Paulo
ZIP/Postal Code
04032-060
Country
Brazil
Facility Name
Local Institution - 0029
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Local Institution - 0100
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Local Institution - 0045
City
Clermont Ferrand Cedex 1
ZIP/Postal Code
63000
Country
France
Facility Name
Local Institution - 0043
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution - 0042
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Local Institution - 0044
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Local Institution - 0027
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Local Institution - 0054
City
Halle (saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
Local Institution - 0028
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Local Institution - 0030
City
Munchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Local Institution - 0023
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Local Institution - 0031
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Facility Name
Local Institution - 0024
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Local Institution - 0020
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution - 0025
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Local Institution - 0091
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
807-8555
Country
Japan
Facility Name
Local Institution - 0090
City
Sapporo-City
State/Province
Hokkaido
ZIP/Postal Code
060-0011
Country
Japan
Facility Name
Local Institution - 0078
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Local Institution - 0082
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
3058576
Country
Japan
Facility Name
Local Institution - 0083
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
2168511
Country
Japan
Facility Name
Local Institution - 0084
City
Kumamoto-city
State/Province
Kumamoto
ZIP/Postal Code
8608556
Country
Japan
Facility Name
Local Institution - 0088
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
8528501
Country
Japan
Facility Name
Local Institution
City
Sasebo city
State/Province
Nagasaki
ZIP/Postal Code
857-1195
Country
Japan
Facility Name
Local Institution - 0077
City
Iruma-gun
State/Province
Saitama
ZIP/Postal Code
3500495
Country
Japan
Facility Name
Local Institution - 0086
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Local Institution - 0079
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
1138603
Country
Japan
Facility Name
Local Institution - 0081
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Local Institution - 0092
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
1608582
Country
Japan
Facility Name
Local Institution - 0093
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
1628666
Country
Japan
Facility Name
Local Institution - 0087
City
Ube-shi
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Local Institution - 0076
City
Miyagi
ZIP/Postal Code
980-8574
Country
Japan
Facility Name
Local Institution - 0066
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Local Institution - 0065
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Local Institution - 0064
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Local Institution - 0049
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Local Institution - 0046
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Local Institution - 0048
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Local Institution - 0047
City
San Luis Potosi
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Local Institution - 0052
City
San Luis Potosi
ZIP/Postal Code
78290
Country
Mexico
Facility Name
Local Institution - 0040
City
Lund
ZIP/Postal Code
22242
Country
Sweden
Facility Name
Local Institution - 0041
City
Orebro
ZIP/Postal Code
70185
Country
Sweden
Facility Name
Local Institution - 0037
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Local Institution - 0038
City
Vasteras
ZIP/Postal Code
72189
Country
Sweden

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Trial to Evaluate the Efficacy and Safety of Abatacept in Combination With Standard Therapy Compared to Standard Therapy Alone in Improving Disease Activity in Adults With Active Idiopathic Inflammatory Myopathy

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