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
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT02971683 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Bristol-Myers Squibb |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Bristol-Myers Squibb |
Principal Investigator Affiliation | Bristol-Myers Squibb |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Australia, Brazil, Czechia, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, Sweden, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Polymyositis, Dermatomyositis, Autoimmune Necrotizing Myopathy, Overlap Myositis, Juvenile Myositis Above the Age of 18 |
Study Website: | View Trial Website |
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.
Drug: - Abatacept subcutaneous
Specified dose of Abatacept subcutaneous on specified days
Drug: - Placebo
Placebo of Abatacept subcutaneous
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Not yet recruiting
Address
Local Institution
Phoenix, Arizona, 85018
Status
Recruiting
Address
Neuromuscular Research Center
Phoenix, Arizona, 85028
Status
Recruiting
Address
Attune Health Research, Inc
Beverly Hills, California, 90211
Status
Not yet recruiting
Address
Local Institution
Fullerton, California, 92835
Status
Recruiting
Address
University Of California Los Angeles
Los Angeles, California, 90024
Status
Recruiting
Address
University of California, Irvine
Orange, California, 92868
Status
Not yet recruiting
Address
Local Institution
Upland, California, 91786
Status
Recruiting
Address
George Washington Medical Faculty Associates
Washington, District of Columbia, 20037
Status
Recruiting
Address
Center For Rheumatology
Fort Lauderdale, Florida, 33309
Status
Recruiting
Address
University of Miami Hospital/Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Status
Recruiting
Address
The University of Kansas Medical Center - Parkinson's Disease & Movement Disorder Center
Kansas City, Kansas, 66160
Status
Not yet recruiting
Address
Local Institution
Baltimore, Maryland, 21224
Status
Recruiting
Address
Harvard Medical School - Brigham and Women's Hospital (BWH) - The Schuster Family Transplantation Re
Boston, Massachusetts, 02115
Status
Recruiting
Address
University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Ce
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
St. Paul Rheumatology, PA
Eagan, Minnesota, 55121
Status
Not yet recruiting
Address
Local Institution
Rochester, Minnesota, 55905
Status
Recruiting
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110
Status
Recruiting
Address
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Status
Recruiting
Address
Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
Status
Not yet recruiting
Address
Local Institution
Bronx, New York, 10451
Status
Recruiting
Address
Hospital For Special Surgery
New York, New York, 10021
Status
Recruiting
Address
Carolina Arthritis Associates
Wilmington, North Carolina, 28401
Status
Recruiting
Address
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Status
Recruiting
Address
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130
Status
Recruiting
Address
Lynn Institute of Norman
Norman, Oklahoma, 73069
Status
Recruiting
Address
East Penn Rheumatology Associates, PC
Bethlehem, Pennsylvania, 18015
Status
Recruiting
Address
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15213
Status
Recruiting
Address
Articluaris Healthcare Group d/b/a ACME Research
Orangeburg, South Carolina, 29118
Status
Recruiting
Address
West Tennessee Research Institute
Jackson, Tennessee, 38305
Status
Recruiting
Address
Austin Neuromusclar Center
Austin, Texas, 78756
Status
Not yet recruiting
Address
Local Institution
Dallas, Texas, 75231
Status
Recruiting
Address
Nerve And Muscle Center Of Texas
Houston, Texas, 77030
Status
Recruiting
Address
University of Washington
Seattle, Washington, 98195
Status
Recruiting
Address
Local Institution
Camperdown, New South Wales, 2050
Status
Recruiting
Address
Local Institution
St Leonards, New South Wales, 2065
Status
Recruiting
Address
Local Institution
Auchenflower, Queensland, 4066
Status
Not yet recruiting
Address
Local Institution
Malvern East, Victoria, 3145
Status
Recruiting
Address
Local Institution
Murdoch, Western Australia, 6150
Status
Recruiting
Address
Local Institution
Salvador, Bahia, 40150-150
Status
Recruiting
Address
Local Institution
Juiz de Fora, Minas Gerais, 36010-570
Status
Recruiting
Address
Local Institution
Porto Alegre, RIO Grande DO SUL, 90480-000
Status
Not yet recruiting
Address
Local Institution
Porto Alegre, RIO Grande DO SUL, 90560-030
Status
Recruiting
Address
Local Institution
Bairro Jardim, SAO Paulo, 09090-790
Status
Not yet recruiting
Address
Local Institution
Sao Paulo, , 04032-060
Status
Recruiting
Address
Local Institution
Vitoria/ES, , CEP-29055-450
Status
Recruiting
Address
Local Institution
Praha 2, , 12850
Status
Recruiting
Address
Local Institution
Brest, , 29609
Status
Recruiting
Address
Local Institution
Clermont Ferrand Cedex 1, , 63000
Status
Recruiting
Address
Local Institution
Lille Cedex, , 59037
Status
Recruiting
Address
Local Institution
Nantes, , 44000
Status
Recruiting
Address
Local Institution
Nice, , 6000
Status
Recruiting
Address
Local Institution
Paris, , 75651
Status
Recruiting
Address
Local Institution
Strasbourg, , 67098
Status
Recruiting
Address
Local Institution
Berlin, , 12200
Status
Not yet recruiting
Address
Local Institution
Freiburg, , 79106
Status
Not yet recruiting
Address
Local Institution
Gottingen, , 37075
Status
Recruiting
Address
Local Institution
Halle (saale), , 06120
Status
Recruiting
Address
Local Institution
Hamburg, , 22763
Status
Not yet recruiting
Address
Local Institution
Hannover, , 30625
Status
Recruiting
Address
Local Institution
Munchen, , 80336
Status
Withdrawn
Address
Local Institution
Budapest, , 1083
Status
Withdrawn
Address
Local Institution
Debrecen, , 4012
Status
Recruiting
Address
Local Institution
Brescia, , 25123
Status
Recruiting
Address
Local Institution
Ferrara, , 44121
Status
Recruiting
Address
Local Institution
Firenze, , 50139
Status
Recruiting
Address
Local Institution
Padova, , 35128
Status
Recruiting
Address
Local Institution
Pavia, , 27100
Status
Recruiting
Address
Local Institution
Pisa, , 56126
Status
Recruiting
Address
Local Institution
Kitakyushu, Fukuoka, 807-8555
Status
Recruiting
Address
Local Institution
Sapporo, Hokkaido, 060-8604
Status
Recruiting
Address
Local Institution
Sapporo, Hokkaido, 060-8648
Status
Recruiting
Address
Local Institution
Tsukuba, Ibaraki, 3058576
Status
Recruiting
Address
Local Institution
Kawasaki-shi, Kanagawa, 216-8511
Status
Recruiting
Address
Local Institution
Nagasaki-shi, Nagasaki, 852-8501
Status
Recruiting
Address
Local Institution
Sasebo-shi, Nagasaki, 857-1195
Status
Recruiting
Address
Local Institution
Iruma-gun, Saitama, 3500495
Status
Recruiting
Address
Local Institution
Bunkyo-ku, Tokyo, 113-8519
Status
Recruiting
Address
Local Institution
Bunkyo-ku, Tokyo, 113-8603
Status
Recruiting
Address
Local Institution
Chuo-ku, Tokyo, 104-8560
Status
Recruiting
Address
Local Institution
Shinjuku-ku, Tokyo, 1608582
Status
Recruiting
Address
Local Institution
Shinjuku-Ku, Tokyo, 1628666
Status
Recruiting
Address
Local Institution
Ube-shi, Yamaguchi, 755-8505
Status
Recruiting
Address
Local Institution
Kumamoto, , 8608556
Status
Recruiting
Address
Local Institution
Miyagi, , 980-8574
Status
Recruiting
Address
Local Institution
Seoul, , 02447
Status
Recruiting
Address
Local Institution
Seoul, , 110-744
Status
Recruiting
Address
Local Institution
Seoul, , 133-792
Status
Recruiting
Address
Local Institution
Mexico City, Distrito Federal, 06700
Status
Recruiting
Address
Local Institution
Mexico, Distrito Federal, 11850
Status
Recruiting
Address
Local Institution
Mexico city, Estado DE Mexico, 14080
Status
Recruiting
Address
Local Institution
Guadalajara, Jalisco, 44160
Status
Recruiting
Address
Local Institution
San Luis Potosi, , 78213
Status
Recruiting
Address
Local Institution
San Luis Potosi, , 78290
Status
Not yet recruiting
Address
Local Institution
Gothenburg, , 41345
Status
Recruiting
Address
Local Institution
Lund, , 22184
Status
Recruiting
Address
Local Institution
Orebro, , 70185
Status
Recruiting
Address
Local Institution
Solna, , 17176
Status
Recruiting
Address
Local Institution
Vasteras, , 72189