An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01357668 |
Recruitment Status :
Recruiting
First Posted : May 23, 2011
Last Update Posted : June 23, 2022
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Condition or disease |
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Juvenile Idiopathic Arthritis |
Study Type : | Observational |
Estimated Enrollment : | 800 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis |
Actual Study Start Date : | January 30, 2013 |
Estimated Primary Completion Date : | January 2, 2029 |
Estimated Study Completion Date : | January 2, 2029 |

Group/Cohort |
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Patients with JIA who are treated with Abatacept
Patients with JIA who are treated with Abatacept according to physicians'/families' decisions
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- Incidence rate of serious infections [ Time Frame: 10 years ]
- Incidence rate of malignancies [ Time Frame: 10 years ]
- Incidence rate of autoimmune disorders [ Time Frame: 10 years ]
- Number of serious adverse events [ Time Frame: 10 years ]
- Number of targeted infections (Epstein-Barr virus, cytomegalovirus, papilloma virus, herpes zoster, tuberculosis and opportunistic infections) [ Time Frame: 10 years ]
Biospecimen Retention: Samples Without DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | up to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Diagnosis of JIA (any subtype)
- Age < 18 years at the time of enrollment unless currently or previously enrolled in an abatacept clinical trial and received abatacept
- Receiving Abatacept at the time of enrollment as per treating physician's decision or received abatacept in a clinical trial
- Parent or legally acceptable representative willing to participate in the study and sign the informed consent
Exclusion Criteria:
- Pregnant or nursing female at the time of enrollment
- Prior malignancies if the patient has not been malignancy free for at least 5 years.
- Any serious acute or chronic medical condition other than JIA, including chronic infection, which would compromise the patient's ability to participate in the study
- Known poor compliance with clinic visits (based on physician judgment)

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): NCT01357668
Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com | 855-907-3286 | Clinical.Trials@bms.com | |
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time |
United States, New Jersey | |
Bristol-Myers Squibb, Active | Recruiting |
Princeton, New Jersey, United States, 08540 | |
Contact: Mr Bristol-Myers Squibb, Site 0001 | |
Austria | |
Local Institution | Recruiting |
Innsbruck, Austria, A-6020 | |
Contact: Site 0002 | |
Brazil | |
Local Institution | Recruiting |
Botucatu, Sao Paulo, Brazil, 18618-970 | |
Contact: Site 0010 | |
Canada, Quebec | |
Local Institution | Recruiting |
Montreal, Quebec, Canada, H4A 3J1 | |
Contact: Site 0011 | |
Denmark | |
Local Institution | Recruiting |
Copenhagen, Denmark, 2100 | |
Contact: Site 0012 | |
France | |
Local Institution | Recruiting |
Paris Cedex 15, France, 75743 | |
Contact: Site 0005 | |
Germany | |
Local Institution | Recruiting |
Bad Bramstedt, Germany, 24576 | |
Contact: Site 0003 | |
Greece | |
Local Institution | Recruiting |
Thessaloniki, Greece, 54642 | |
Contact: Site 0016 | |
Hungary | |
Local Institution | Recruiting |
Budapest, Hungary, H-1023 | |
Contact: Site 0017 | |
Israel | |
Local Institution | Completed |
Jerusalem, Israel, 91031 | |
Italy | |
Local Institution | Recruiting |
Genova, Italy, 16147 | |
Contact: Site 0015 | |
Latvia | |
Local Institution | Recruiting |
Riga, Latvia, LV-1007 | |
Contact: Site 0018 | |
Mexico | |
Local Institution | Recruiting |
Guadalajara, Jalisco, Mexico, 44620 | |
Contact: Site 0006 | |
Netherlands | |
Local Institution | Recruiting |
Utrecht, Netherlands, 3584 EA | |
Contact: Site 0019 | |
Peru | |
Local Institution | Recruiting |
Lima, Peru, 1 | |
Contact: Site 0007 | |
Portugal | |
Local Institution | Recruiting |
Lisboa, Portugal, 1600 | |
Contact: Site 0020 | |
Puerto Rico | |
Centro de Reumatologia Pediatrico de Puerto Rico | Completed |
Bayamon, Puerto Rico, PR 960 | |
Romania | |
Local Institution | Recruiting |
Cluj-Napoca, Romania | |
Contact: Site 0021 | |
Russian Federation | |
Local Institution | Terminated |
Moscow, Russian Federation, 119991 | |
Slovakia | |
Local Institution | Recruiting |
Piestany, Slovakia | |
Contact: Site 0022 | |
South Africa | |
Local Institution | Recruiting |
Pretoria, Gauteng, South Africa, 0002 | |
Contact: Site 0009 | |
Spain | |
Local Institution | Recruiting |
Barcelona, Spain, 08035 | |
Contact: Site 0004 | |
United Kingdom | |
Local Institution | Completed |
Bristol, United Kingdom, BS2 8BJ |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT01357668 |
Other Study ID Numbers: |
IM101-240 |
First Posted: | May 23, 2011 Key Record Dates |
Last Update Posted: | June 23, 2022 |
Last Verified: | June 2022 |
Arthritis Arthritis, Juvenile Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |