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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02971683
Ethics application status
Date submitted
21/11/2016
Date registered
23/11/2016
Date last updated
30/01/2019

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 subjects who achieve International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 - The IMACS DOI is:
An improvement of = 20% from baseline in 3 IMACS core measures AND
No more than 2 IMACS core measure scores worsen by = 25% from baseline, AND
Manual Muscle Test (MMT-8) may not decrease by = 25% from baseline
Timepoint [1] 0 0
At Week 24
Secondary outcome [1] 0 0
Mean change from baseline to Week 24 in muscle endurance test using the Myositis Function Index (FI-2)
Timepoint [1] 0 0
Baseline and Week 24
Secondary outcome [2] 0 0
Mean change from baseline to Week 24 in extra-muscular disease activity as defined by Myositis Disease Activity Assessment Tool (MDAAT)
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Mean change from baseline to Week 24 in Myositis Response Criteria (MRC) score
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [4] 0 0
Mean change from baseline to Week 24 in functional disability using the Health Assessment Questionnaire-Disability Index (HAQ-DI)
Timepoint [4] 0 0
Baseline and Week 24

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com



-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
Gender
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 could 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Local Institution - St Leonards
Recruitment hospital [3] 0 0
Local Institution - Auchenflower
Recruitment hospital [4] 0 0
Local Institution - Malvern East
Recruitment hospital [5] 0 0
Local Institution - 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
3145 - Malvern East
Recruitment postcode(s) [5] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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District of Columbia
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Florida
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United States of America
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Kansas
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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
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Michigan
Country [9] 0 0
United States of America
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Minnesota
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United States of America
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Missouri
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Nebraska
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New Hampshire
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New York
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North Carolina
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United States of America
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Ohio
Country [16] 0 0
United States of America
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Oklahoma
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Pennsylvania
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
Country [21] 0 0
Brazil
State/province [21] 0 0
Bahia
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Brazil
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Espirito Santo
Country [23] 0 0
Brazil
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Minas Gerais
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Brazil
State/province [24] 0 0
RIO Grande DO SUL
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Brazil
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SAO Paulo
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Brazil
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Sao Paulo
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Czechia
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Praha 2
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France
State/province [28] 0 0
Brest
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France
State/province [29] 0 0
Clermont Ferrand Cedex 1
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France
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Lille Cedex
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France
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Nantes
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France
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Nice
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France
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Paris
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France
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Strasbourg
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Germany
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Berlin
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Germany
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Freiburg
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Germany
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Gottingen
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Germany
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Halle (saale)
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Munchen
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Hungary
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Budapest
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Hungary
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Debrecen
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Italy
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Brescia
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Italy
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Ferrara
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Italy
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Firenze
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Italy
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Padova
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Italy
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Pavia
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Italy
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Pisa
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Ibaraki
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Japan
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Kanagawa
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Japan
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Nagasaki
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Japan
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Saitama
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Japan
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Tokyo
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Japan
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Yamaguchi
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Japan
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Bunkyo-ku
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Japan
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Chuo-ku
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Japan
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Kumamoto
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Japan
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Miyagi
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Korea, Republic of
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Seoul
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Mexico
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Distrito Federal
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Mexico
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Estado DE Mexico
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Mexico
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Jalisco
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Mexico
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San Luis Potosi
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Sweden
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Gothenburg
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Sweden
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Lund
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Sweden
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Orebro
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Sweden
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Solna
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Sweden
State/province [71] 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/show/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
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Address 0 0
Country 0 0
Phone 0 0
please email:
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

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