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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02971683




Registration number
NCT02971683
Ethics application status
Date submitted
21/11/2016
Date registered
23/11/2016
Date last updated
30/10/2023

Titles & IDs
Public 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
Scientific 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)
Secondary ID [1] 0 0
2016-002269-77
Secondary ID [2] 0 0
IM101-611
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polymyositis 0 0
Dermatomyositis 0 0
Autoimmune Necrotizing Myopathy 0 0
Overlap Myositis 0 0
Juvenile Myositis Above the Age of 18 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Abatacept subcutaneous
Treatment: Drugs - Placebo

Active comparator: Abatacept subcutaneous + Standard Treatment - 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 comparator: Placebo of Abatacept subcutaneous + 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.


Treatment: Drugs: Abatacept subcutaneous
Specified dose of Abatacept subcutaneous on specified days

Treatment: Drugs: Placebo
Placebo of Abatacept subcutaneous
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue
Timepoint [1] 0 0
From first dose to 24 weeks after first dose. (Approximately 169 days)
Secondary outcome [1] 0 0
Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24
Timepoint [1] 0 0
From first dose to 24 weeks after first dose. (Approximately 169 days)
Secondary outcome [2] 0 0
Mean Change in Muscle Endurance Using the Myositis Function Index (FI-2) From Baseline to Week 24
Timepoint [2] 0 0
From first dose to 24 weeks after first dose. (Approximately 169 days)
Secondary outcome [3] 0 0
Mean Change in Myositis Disease Activity Assessment Tool (MDAAT) Assessment of Extra-muscular From Baseline to Week 24
Timepoint [3] 0 0
From first dose to 24 weeks after first dose. (Approximately 169 days)
Secondary outcome [4] 0 0
Myositis Response Criteria (MRC) Total Improvement Score From Baseline to Week 24
Timepoint [4] 0 0
From first dose to 24 weeks after first dose. (Approximately 169 days)
Secondary outcome [5] 0 0
Number of Participants Experiencing Adverse Events (AE) in the Double-Blind Period
Timepoint [5] 0 0
From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period. (Up to approximately 274 days)
Secondary outcome [6] 0 0
Number of Participants Experiencing Serious Adverse Events (SAE) in the Double-Blind Period
Timepoint [6] 0 0
From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period. (Up to approximately 274 days)
Secondary outcome [7] 0 0
Number of Participants Experiencing Adverse Events (AE) of Special Interest in the Double-Blind Period
Timepoint [7] 0 0
From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period. (Up to approximately 274 days)
Secondary outcome [8] 0 0
Number of Participants Experiencing Laboratory Test Abnormalities in the Double-Blind Period
Timepoint [8] 0 0
From first dose up to approximately 56 days post last dose date in double-blind period or first dose in open-label period. (Up to approximately 274 days)
Secondary outcome [9] 0 0
Number of Participants Experiencing Adverse Events (AE) in the Cumulative Abatacept Period
Timepoint [9] 0 0
From first dose up to approximately 56 days post last dose (up to approximately 54 months)
Secondary outcome [10] 0 0
Number of Participants Experiencing Serious Adverse Events (SAE) in the Cumulative Abatacept Period
Timepoint [10] 0 0
From first dose up to approximately 56 days post last dose (up to approximately 54 months)
Secondary outcome [11] 0 0
Number of Participants Experiencing Adverse Events (AE) of Special Interest in the Cumulative Abatacept Period
Timepoint [11] 0 0
From first dose up to approximately 56 days post last dose (up to approximately 54 months)
Secondary outcome [12] 0 0
Number of Participants Experiencing Laboratory Test Abnormalities in the Open-Label Period
Timepoint [12] 0 0
From first dose in open label period to first dose date in the subsequent period or up to 56 days post last dose (up to approximately 666 days)
Secondary outcome [13] 0 0
Number of Participants Experiencing Laboratory Test Abnormalities in the Long-Term Open Label Period
Timepoint [13] 0 0
From first dose in the Long-Term Open Label Period up to 56 days post last dose in the Long-Term Open Label Period (up to approximately 958 days)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/08/2022
Sample size
Target
Accrual to date
Final
149
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Local Institution - 0051 - Camperdown
Recruitment hospital [2] 0 0
Local Institution - 0053 - St Leonards
Recruitment hospital [3] 0 0
Local Institution - 0035 - Auchenflower
Recruitment hospital [4] 0 0
Local Institution - 0036 - Murdoch
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4066 - Auchenflower
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New Hampshire
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Brazil
State/province [21] 0 0
Bahia
Country [22] 0 0
Brazil
State/province [22] 0 0
Espirito Santo
Country [23] 0 0
Brazil
State/province [23] 0 0
Minas Gerais
Country [24] 0 0
Brazil
State/province [24] 0 0
RIO Grande DO SUL
Country [25] 0 0
Brazil
State/province [25] 0 0
SAO Paulo
Country [26] 0 0
Brazil
State/province [26] 0 0
Rio Grande Do Sul
Country [27] 0 0
Brazil
State/province [27] 0 0
Sao Paulo
Country [28] 0 0
Czechia
State/province [28] 0 0
Praha 2
Country [29] 0 0
France
State/province [29] 0 0
Brest
Country [30] 0 0
France
State/province [30] 0 0
Clermont Ferrand Cedex 1
Country [31] 0 0
France
State/province [31] 0 0
Lille Cedex
Country [32] 0 0
France
State/province [32] 0 0
Paris
Country [33] 0 0
France
State/province [33] 0 0
Strasbourg
Country [34] 0 0
Germany
State/province [34] 0 0
Berlin
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Germany
State/province [35] 0 0
Halle (saale)
Country [36] 0 0
Germany
State/province [36] 0 0
Hamburg
Country [37] 0 0
Germany
State/province [37] 0 0
Munchen
Country [38] 0 0
Italy
State/province [38] 0 0
Lombardia
Country [39] 0 0
Italy
State/province [39] 0 0
Ferrara
Country [40] 0 0
Italy
State/province [40] 0 0
Firenze
Country [41] 0 0
Italy
State/province [41] 0 0
Padova
Country [42] 0 0
Italy
State/province [42] 0 0
Pisa
Country [43] 0 0
Japan
State/province [43] 0 0
Fukuoka
Country [44] 0 0
Japan
State/province [44] 0 0
Hokkaido
Country [45] 0 0
Japan
State/province [45] 0 0
Ibaraki
Country [46] 0 0
Japan
State/province [46] 0 0
Kanagawa
Country [47] 0 0
Japan
State/province [47] 0 0
Kumamoto
Country [48] 0 0
Japan
State/province [48] 0 0
Nagasaki
Country [49] 0 0
Japan
State/province [49] 0 0
Saitama
Country [50] 0 0
Japan
State/province [50] 0 0
Tokyo
Country [51] 0 0
Japan
State/province [51] 0 0
Yamaguchi
Country [52] 0 0
Japan
State/province [52] 0 0
Miyagi
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Seoul
Country [54] 0 0
Mexico
State/province [54] 0 0
Distrito Federal
Country [55] 0 0
Mexico
State/province [55] 0 0
Jalisco
Country [56] 0 0
Mexico
State/province [56] 0 0
San Luis Potosi
Country [57] 0 0
Sweden
State/province [57] 0 0
Lund
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Sweden
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Orebro
Country [59] 0 0
Sweden
State/province [59] 0 0
Stockholm
Country [60] 0 0
Sweden
State/province [60] 0 0
Vasteras

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT02971683
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02971683