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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

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ClinicalTrials.gov Identifier: NCT02971683
Recruitment Status : Recruiting
First Posted : November 23, 2016
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Polymyositis Dermatomyositis Autoimmune Necrotizing Myopathy Overlap Myositis Juvenile Myositis Above the Age of 18 Drug: Abatacept subcutaneous Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : March 13, 2017
Estimated Primary Completion Date : June 17, 2020
Estimated Study Completion Date : June 4, 2021


Arms and Interventions

Arm Intervention/treatment
Active Comparator: Abatacept subcutaneous + Standard Treatment
Abatacept subcutaneous weekly in addition to the subject's current standard treatment for 24 weeks followed by followed by a 28 week open-label period of abatacept treatment plus the subject's current standard treatment.
Drug: Abatacept subcutaneous
Specified dose of Abatacept subcutaneous on specified days
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 followed by a 28 week open-label period of abatacept treatment plus the subject's current standard treatment.
Drug: Abatacept subcutaneous
Specified dose of Abatacept subcutaneous on specified days
Drug: Placebo
Placebo of Abatacept subcutaneous


Outcome Measures

Primary Outcome Measures :
  1. Number of subjects who achieve International Myositis Assessment and Clinical Studies Definition of Improvement (IMACS DOI) at Week 24 [ Time Frame: 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


Secondary Outcome Measures :
  1. Mean change from baseline to Week 12 in muscle endurance test using the Myositis Function Index (FI-2) [ Time Frame: Baseline and Week 12 ]
  2. Mean change from baseline to Week 24 in muscle endurance test using the Myositis Function Index (FI-2) [ Time Frame: Baseline and Week 24 ]
  3. Mean change from baseline to Week 12 in extra-muscular disease activity as defined by Myositis Disease Activity Assessment Tool (MDAAT) [ Time Frame: Baseline and Week 12 ]
  4. Mean change from baseline to Week 24 in extra-muscular disease activity as defined by Myositis Disease Activity Assessment Tool (MDAAT) [ Time Frame: Baseline and Week 24 ]
  5. Mean change from baseline to Week 12 in Myositis Response Criteria (MRC) score [ Time Frame: Baseline and Week 12 ]
  6. Mean change from baseline to Week 24 in Myositis Response Criteria (MRC) score [ Time Frame: Baseline and Week 24 ]
  7. Mean change from baseline to Week 12 in functional disability using the Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline and Week 12 ]
  8. Mean change from baseline to Week 24 in functional disability using the Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline and Week 24 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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) or a prior muscle biopsy diagnostic for IIM or a positive test for at least one identified myositis-associated autoantibody; ii) Subjects with IIM other than DM (PM, autoimmune necrotizing myopathy, myositis associated with other autoimmune connective diseases (overlap myositis), or juvenile myositis with age ≥ 18 years) must also have a prior muscle biopsy diagnostic for IIM or a positive test for at least one identified myositis-associated autoantibody

  • 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, lactate dehydrogenase (LDH), aspartate aminotransferase (AST), ALT) ≥ 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 1 month 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.

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 past year or any other biologic treatment or Intravenous Immunoglobulin (IVIG) in the past 6 months.
  • 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
  • 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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971683


Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

  Hide Study Locations
Locations
United States, Arizona
Local Institution Not yet recruiting
Phoenix, Arizona, United States, 85018
Contact: Site 0007         
Neuromuscular Research Center Recruiting
Phoenix, Arizona, United States, 85028
Contact: Kumaraswamy Sivakumar, Site 0015    480-314-1007      
United States, California
Attune Health Recruiting
Beverly Hills, California, United States, 90039
Contact: Florence Figueras    310-360-9197      
Contact: Site 0075         
Local Institution Not yet recruiting
Fullerton, California, United States, 92835
Contact: Site 0001         
Local Institution Not yet recruiting
Los Angeles, California, United States, 90095-1670
Contact: Site 0009         
University Of California, Irvine Recruiting
Orange, California, United States, 92868
Contact: Tahseen Mozaffar, Site 0012    714-456-7352      
Local Institution Not yet recruiting
Upland, California, United States, 91786
Contact: Site 0050         
United States, District of Columbia
Medical Faculty Associates Recruiting
Washington, District of Columbia, United States, 20037
Contact: Rodolfo Curiel, Site 0057    202-677-6141      
United States, Florida
Center for Rheumatology Recruiting
Fort Lauderdale, Florida, United States, 33334
Contact: Yvonne R.S Sherrer, Site 0018    954-229-0425      
University of Miami Medical Center Recruiting
Miami, Florida, United States, 33136
Contact: Dana Ascherman, Site 0013    305-243-8567      
United States, Kansas
The University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Mazen Dimachkie, Site 0006    913-588-5703      
United States, Maryland
Local Institution Not yet recruiting
Baltimore, Maryland, United States, 21224
Contact: Site 0062         
United States, Massachusetts
Local Institution Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Site 0058         
United States, Minnesota
St. Paul Rheumatology, PA Recruiting
Eagan, Minnesota, United States, 55121
Contact: David Ridley, Site 0002    651-361-8659      
Local Institution Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Site 0003         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Renee Renna Site 0063    314-362-1626      
United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198
Contact: Michael Feely, Site 0011    402-559-8140      
United States, New Hampshire
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Stephanie Mathew, Site 0004    603-653-0492      
United States, New York
Local Institution Not yet recruiting
Bronx, New York, United States, 10451
Contact: Site 0019         
United States, North Carolina
Carolina Arthritis Associates Recruiting
Wilmington, North Carolina, United States, 28401
Contact: Mark Harris, Site 0010    910-762-1182      
United States, Ohio
Local Institution Not yet recruiting
Columbus, Ohio, United States, 43203
Contact: Site 0056         
United States, Oklahoma
Lynn Institute of Norman Recruiting
Norman, Oklahoma, United States, 73072
Contact: Robert Mcarthur, Site 0059    405-701-2466      
United States, Pennsylvania
East Penn Rheumatology Associates, P.C. Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Charles Ludivico, Site 0055    610-868-1336      
Local Institution Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Site 0014         
United States, South Carolina
ACME Research, LLC Recruiting
Orangeburg, South Carolina, United States, 29118
Contact: Mitchell Feinman, Site 0005    803-539-2224      
United States, Tennessee
West Tennessee Research Institute Recruiting
Jackson, Tennessee, United States, 38305
Contact: Jacob Aelion, Site 0017    731-633-0045      
United States, Texas
Local Institution Not yet recruiting
Dallas, Texas, United States, 75231
Contact: Site 0008         
Nerve And Muscle Center Of Texas Recruiting
Houston, Texas, United States, 77030
Contact: Aziz Shaibani, Site 0016    713-795-0033      
Australia, New South Wales
Local Institution Recruiting
Camperdown, New South Wales, Australia, 2050
Contact: Site 0051         
Local Institution Recruiting
Sydney, New South Wales, Australia, 2065
Contact: Site 0053         
Australia, Queensland
Wesley Medical Research Institute - Brisbane QLD Recruiting
Auchenflower, Queensland, Australia, 4066
Contact: Daman Michael Langguth, Site 0035    +61 733778690      
Australia, Victoria
Local Institution Not yet recruiting
Malvern East, Victoria, Australia, 3145
Contact: Site 0034         
Australia, Western Australia
Fiona Stanley Hospital Recruiting
Murdoch, Western Australia, Australia, 6150
Contact: Merrilee Needham, Site 0036    +61893601370      
Brazil
Local Institution Not yet recruiting
Salvador, Bahia, Brazil, 40150-150
Contact: Site 0073         
Local Institution Not yet recruiting
Vitoria, Espirito Santo, Brazil, 29055-450
Contact: Site 0070         
Local Institution Not yet recruiting
Juiz de Fora, Minas Gerais, Brazil, 36010-570
Contact: Site 0069         
Local Institution Not yet recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90480-000
Contact: Site 0072         
Local Institution Not yet recruiting
Porto Alegre, RIO Grande DO SUL, Brazil, 90560-030
Contact: Site 0067         
Local Institution Not yet recruiting
Bairro Jardim, SAO Paulo, Brazil, 09090-790
Contact: Site 0074         
Local Institution Not yet recruiting
Sao Paulo, Brazil, 04032-060
Contact: Site 0071         
Czechia
Local Institution Not yet recruiting
Praha 2, Czechia, 12850
Contact: Site 0029         
France
Local Institution Recruiting
Clermont Ferrand Cedex 1, France, 63000
Contact: Site 0045         
Local Institution Not yet recruiting
Lille Cedex, France, 59037
Contact: Site 0043         
Local Institution Not yet recruiting
Nantes, France, 44093
Contact: Site 0060         
Local Institution Recruiting
Nice, France, 6000
Contact: Site 0061         
Local Institution Recruiting
Paris, France, 75013
Contact: Site 0042         
Local Institution Recruiting
Strasbourg, France, 67098
Contact: Site 0044         
Germany
Local Institution Not yet recruiting
Berlin, Germany, 12200
Contact: Site 0027         
Local Institution Not yet recruiting
Freiburg, Germany, 79106
Contact: Site 0080         
Local Institution Not yet recruiting
Gottingen, Germany, 37075
Contact: Site 0032         
Local Institution Not yet recruiting
Halle (Saale), Germany, 06120
Contact: Site 0054         
Local Institution Recruiting
Hamburg, Germany, 22763
Contact: Site 0028         
Local Institution Not yet recruiting
Hannover, Germany, 30625
Contact: Site 0033         
Local Institution Not yet recruiting
Munchen, Germany, 80336
Contact: Site 0030         
Hungary
Local Institution Not yet recruiting
Budapest, Hungary, 1083
Contact: Site 0022         
Local Institution Not yet recruiting
Debrecen, Hungary, 4012
Contact: Site 0021         
Italy
Local Institution Recruiting
Brescia, Italy, 25123
Contact: Site 0026         
Local Institution Not yet recruiting
Ferrara, Italy, 44121
Contact: Site 0031         
Local Institution Not yet recruiting
Firenze, Italy, 50139
Contact: Site 0024         
Local Institution Not yet recruiting
Padova, Italy, 35128
Contact: Site 0020         
Local Institution Not yet recruiting
Pavia, Italy, 27100
Contact: Site 0023         
Local Institution Not yet recruiting
Pisa, Italy, 56126
Contact: Site 0025         
Japan
Local Institution Recruiting
Sapporo, Hokkaido, Japan, 060-8648
Contact: Site 0078         
Local Institution Not yet recruiting
Tsukuba, Ibaraki, Japan, 305-8576
Contact: Site 0082         
Local Institution Not yet recruiting
Kawasaki, Kanagawa, Japan, 216-8511
Contact: Site 0083         
Local Institution Recruiting
Sasebo-shi, Nagasaki, Japan, 857-1195
Contact: Site 0085         
Local Institution Not yet recruiting
Iruma-gun, Saitama, Japan, 350-0495
Contact: Site 0077         
Local Institution Not yet recruiting
Bunkyo-ku, Tokyo, Japan, 113-8603
Contact: Site 0079         
Local Institution Not yet recruiting
Chuo-ku, Tokyo, Japan, 104-8560
Contact: Site 0081         
Local Institution Not yet recruiting
Kumamoto, Japan, 8608556
Contact: Site 0084         
Local Institution Not yet recruiting
Miyagi, Japan, 980-8574
Contact: Site 0076         
Local Institution Not yet recruiting
Tokyo, Japan, 113-8519
Contact: Site 0086         
Korea, Republic of
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 02447
Contact: Site 0066         
Local Institution Recruiting
Seoul, Korea, Republic of, 03080
Contact: Site 0065         
Local Institution Recruiting
Seoul, Korea, Republic of, 04763
Contact: Site 0064         
Mexico
Local Institution Not yet recruiting
Mexico City, Distrito Fededral, Mexico, 11850
Contact: Site 0046         
Local Institution Not yet recruiting
Mexico City, Estado DE Mexico, Mexico, 0676
Contact: Site 0049         
Local Institution Not yet recruiting
Mexico city, Estado DE Mexico, Mexico, 14080
Contact: Site 0068         
Local Institution Not yet recruiting
Guadalajara, Jalisco, Jalisco, Mexico, 44160
Contact: Site 0048         
Local Institution Not yet recruiting
San Luis Potosi, Mexico, 78213
Contact: Site 0047         
Local Institution Not yet recruiting
San Luis Potosi, Mexico, 78290
Contact: Site 0052         
Sweden
Local Institution Not yet recruiting
Gothenburg, Sweden, 41345
Contact: Site 0039         
Local Institution Not yet recruiting
Lund, Sweden, 22184
Contact: Site 0040         
Local Institution Recruiting
Orebro, Sweden, 70185
Contact: Site 0041         
Local Institution Recruiting
Solna, Sweden, 17176
Contact: Site 0037         
Local Institution Recruiting
Vasteras, Sweden, 72189
Contact: Site 0038         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02971683     History of Changes
Other Study ID Numbers: IM101-611
2016-002269-77 ( EudraCT Number )
First Posted: November 23, 2016    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Muscular Diseases
Dermatomyositis
Myositis
Polymyositis
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents