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An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

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
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to examine the long-term safety of Abatacept for the treatment of juvenile idiopathic arthritis (JIA) with particular in interest in the occurrence of serious infections, autoimmune disorders, and malignancies.

Condition or disease
Juvenile Idiopathic Arthritis

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Patients with JIA who are treated with Abatacept
Patients with JIA who are treated with Abatacept according to physicians'/families' decisions

Primary Outcome Measures :
  1. Incidence rate of serious infections [ Time Frame: 10 years ]
  2. Incidence rate of malignancies [ Time Frame: 10 years ]
  3. Incidence rate of autoimmune disorders [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Number of serious adverse events [ Time Frame: 10 years ]
  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric rheumatology clinics

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)

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): NCT01357668

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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

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United States, New Jersey
Bristol-Myers Squibb, Active Recruiting
Princeton, New Jersey, United States, 08540
Contact: Mr Bristol-Myers Squibb, Site 0001         
Local Institution Recruiting
Innsbruck, Austria, A-6020
Contact: Site 0002         
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         
Local Institution Recruiting
Copenhagen, Denmark, 2100
Contact: Site 0012         
Local Institution Recruiting
Paris Cedex 15, France, 75743
Contact: Site 0005         
Local Institution Recruiting
Bad Bramstedt, Germany, 24576
Contact: Site 0003         
Local Institution Recruiting
Thessaloniki, Greece, 54642
Contact: Site 0016         
Local Institution Recruiting
Budapest, Hungary, H-1023
Contact: Site 0017         
Local Institution Completed
Jerusalem, Israel, 91031
Local Institution Recruiting
Genova, Italy, 16147
Contact: Site 0015         
Local Institution Recruiting
Riga, Latvia, LV-1007
Contact: Site 0018         
Local Institution Recruiting
Guadalajara, Jalisco, Mexico, 44620
Contact: Site 0006         
Local Institution Recruiting
Utrecht, Netherlands, 3584 EA
Contact: Site 0019         
Local Institution Recruiting
Lima, Peru, 1
Contact: Site 0007         
Local Institution Recruiting
Lisboa, Portugal, 1600
Contact: Site 0020         
Puerto Rico
Centro de Reumatologia Pediatrico de Puerto Rico Completed
Bayamon, Puerto Rico, PR 960
Local Institution Recruiting
Cluj-Napoca, Romania
Contact: Site 0021         
Russian Federation
Local Institution Terminated
Moscow, Russian Federation, 119991
Local Institution Recruiting
Piestany, Slovakia
Contact: Site 0022         
South Africa
Local Institution Recruiting
Pretoria, Gauteng, South Africa, 0002
Contact: Site 0009         
Local Institution Recruiting
Barcelona, Spain, 08035
Contact: Site 0004         
United Kingdom
Local Institution Completed
Bristol, United Kingdom, BS2 8BJ
Sponsors and Collaborators
Bristol-Myers Squibb
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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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
Additional relevant MeSH terms:
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Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases