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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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)
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Secondary ID [1]
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2016-002269-77
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Secondary ID [2]
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IM101-611
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Polymyositis
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Dermatomyositis
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Autoimmune Necrotizing Myopathy
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Overlap Myositis
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Juvenile Myositis Above the Age of 18
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Achieving International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 Without Rescue
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Assessment method [1]
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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.
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Timepoint [1]
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From first dose to 24 weeks after first dose. (Approximately 169 days)
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Secondary outcome [1]
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Mean Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24
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Assessment method [1]
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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).
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Timepoint [1]
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From first dose to 24 weeks after first dose. (Approximately 169 days)
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Secondary outcome [2]
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Mean Change in Muscle Endurance Using the Myositis Function Index (FI-2) From Baseline to Week 24
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Assessment method [2]
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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).
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Timepoint [2]
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From first dose to 24 weeks after first dose. (Approximately 169 days)
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Secondary outcome [3]
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Mean Change in Myositis Disease Activity Assessment Tool (MDAAT) Assessment of Extra-muscular From Baseline to Week 24
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Assessment method [3]
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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).
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Timepoint [3]
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From first dose to 24 weeks after first dose. (Approximately 169 days)
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Secondary outcome [4]
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Myositis Response Criteria (MRC) Total Improvement Score From Baseline to Week 24
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Assessment method [4]
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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).
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Timepoint [4]
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From first dose to 24 weeks after first dose. (Approximately 169 days)
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Secondary outcome [5]
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Number of Participants Experiencing Adverse Events (AE) in the Double-Blind Period
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Assessment method [5]
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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.
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Timepoint [5]
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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)
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Secondary outcome [6]
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Number of Participants Experiencing Serious Adverse Events (SAE) in the Double-Blind Period
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Assessment method [6]
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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.
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Timepoint [6]
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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)
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Secondary outcome [7]
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Number of Participants Experiencing Adverse Events (AE) of Special Interest in the Double-Blind Period
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Assessment method [7]
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The number of treated participants experiencing adverse events of special interest: infections, malignancies, autoimmune events, local injection site reactions, and systemic injection reactions.
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Timepoint [7]
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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)
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Secondary outcome [8]
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Number of Participants Experiencing Laboratory Test Abnormalities in the Double-Blind Period
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Assessment method [8]
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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.
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Timepoint [8]
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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)
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Secondary outcome [9]
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Number of Participants Experiencing Adverse Events (AE) in the Cumulative Abatacept Period
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Assessment method [9]
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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.
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Timepoint [9]
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From first dose up to approximately 56 days post last dose (up to approximately 54 months)
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Secondary outcome [10]
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Number of Participants Experiencing Serious Adverse Events (SAE) in the Cumulative Abatacept Period
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Assessment method [10]
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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.
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Timepoint [10]
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From first dose up to approximately 56 days post last dose (up to approximately 54 months)
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Secondary outcome [11]
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Number of Participants Experiencing Adverse Events (AE) of Special Interest in the Cumulative Abatacept Period
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Assessment method [11]
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The number of treated participants experiencing adverse events of special interest: infections, malignancies, autoimmune events, local injection site reactions, and systemic injection reactions.
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Timepoint [11]
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From first dose up to approximately 56 days post last dose (up to approximately 54 months)
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Secondary outcome [12]
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Number of Participants Experiencing Laboratory Test Abnormalities in the Open-Label Period
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Assessment method [12]
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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. For participants who enter the Japan open-label extension period or long-term extension period, assessments after the first dose in the open-label period and before the first dose date in the subsequent period are included. For participants who prematurely discontinue the open-label period or complete the open-label period but do not enter the Japan open-label extension period or long-term term extension period, assessments after the first dose in the open-label period and up to 56 days post last dose are included.
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Timepoint [12]
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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)
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Secondary outcome [13]
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Number of Participants Experiencing Laboratory Test Abnormalities in the Long-Term Open Label Period
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Assessment method [13]
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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. For participants who completed/discontinued the Long-Term Extension Period, assessments after the first dose in the Long-Term Extension Period and up to 56 days post last dose in the Long-Term Extension Period are included.
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Timepoint [13]
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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)
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/05/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/08/2022
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Sample size
Target
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Accrual to date
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Final
149
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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Local Institution - 0051 - Camperdown
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Recruitment hospital [2]
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Local Institution - 0053 - St Leonards
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Recruitment hospital [3]
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Local Institution - 0035 - Auchenflower
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Recruitment hospital [4]
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Local Institution - 0036 - Murdoch
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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4066 - Auchenflower
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Recruitment postcode(s) [4]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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0
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United States of America
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California
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0
0
United States of America
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District of Columbia
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0
0
United States of America
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Florida
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0
0
United States of America
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Kansas
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0
0
United States of America
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Maryland
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0
0
United States of America
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Massachusetts
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0
0
United States of America
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Michigan
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0
0
United States of America
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Minnesota
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0
0
United States of America
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Nebraska
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0
0
United States of America
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New Hampshire
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0
0
United States of America
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New York
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0
0
United States of America
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North Carolina
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0
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Ohio
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0
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Oklahoma
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Pennsylvania
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0
0
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South Carolina
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0
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Tennessee
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Texas
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Washington
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0
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Brazil
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Bahia
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0
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Brazil
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Espirito Santo
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0
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Brazil
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Minas Gerais
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0
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Brazil
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RIO Grande DO SUL
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Brazil
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SAO Paulo
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0
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Brazil
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Rio Grande Do Sul
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0
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Brazil
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Sao Paulo
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0
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Czechia
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Praha 2
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0
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France
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Brest
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0
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France
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Clermont Ferrand Cedex 1
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France
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Lille Cedex
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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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Halle (saale)
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Germany
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Hamburg
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Germany
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Munchen
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Italy
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Lombardia
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0
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Italy
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Ferrara
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0
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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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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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Kumamoto
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Japan
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Nagasaki
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0
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Japan
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Saitama
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0
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Japan
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Tokyo
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0
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Japan
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Yamaguchi
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0
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Japan
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Miyagi
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0
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Korea, Republic of
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Seoul
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0
0
Mexico
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0
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Distrito Federal
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0
0
Mexico
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0
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Jalisco
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0
0
Mexico
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0
0
San Luis Potosi
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0
0
Sweden
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0
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Lund
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0
0
Sweden
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0
0
Orebro
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Sweden
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Stockholm
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Sweden
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Vasteras
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Funding & Sponsors
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Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Ethics approval
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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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02971683
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Public notes
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Contacts
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02971683
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