A Phase 3 trial to evaluate the effectiveness and safety of Abatacept SC alongside standard treatment in comparison to standard treatment alone in improving disease activity in adults with active idiopathic inflammatory myopathy, a group of chronic autoimmune inflammatory diseases that affect skeletal muscle.
- Conditions
- Idiopathic Inflammatory Myopathy (IIMeg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy)MedDRA version: 21.0Level: LLTClassification code 10042753Term: Symptomatic inflammatory myopathySystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2016-002269-77-IT
- Lead Sponsor
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
a) Diagnosis of Definite or Probable IIM (DM or PM) based on the Bohan and Peter classification criteria (outlined in Appendix 3 of the protocol)
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-¿, 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.
b) 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) 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) = 1.3 times upper limit of normal (ULN)
vi) MDAAT Extramuscular Global Activity VAS = 2 cm
c) 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 at screening with no alternate explanation or cause
d) Active disease despite adequate prior treatment experience with corticosteroids, immunosuppressants, or biologics as determined by the investigator
e) 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, mycophenalate mofetil, tacrolimus, or cyclosporine (combinations of these treatments are not allowed), or
iii. A combination of corticosteroids and one of the above immunosuppressants
• If using corticosteroids for IIM, the subject must have been on corticosteroids for at least 12 weeks prior to randomization and a stable dose of corticosteroids for at least 4 weeks prior to randomization.
• If using immunosuppressants other than azathioprine, the subject must have been on a the same medication for at least 12 weeks and a stable dose for at least 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
a) Subjects with Inclusion Body Myositis or myositis other than IIM, e.g. drug-induced myositis and PM associated with HIV.
b) Subjects treated with penicillamine or zidovudine in the past 3 months
c) 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.
d) Subjects with uncontrolled or rapidly progressive interstitial lung disease (at the discretion of the investigator)
e) Subjects with severe muscle damage (Myositis Damage Index > 7/10), permanent weakness due to a non-IIM cause, or myositis with cardiac involvement
f) Cancer-associated myositis (myositis diagnosed within 2 years of a diagnosis of cancer). See criteria (2i)
g) 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.
h) Subjects at risk for tuberculosis
i) Subjects with recent acute infection requiring antibiotics
j) Subjects with history of chronic or recurrent bacterial or viral infections
k) Subjects with active systemic fungal infections (eg, histoplasmosis, blastomycosis, or coccidiomycosis)
l) 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). Additional screening recommendations for malignancy are outlined in Sections 3.3.2 and 3.3.4.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method