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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 : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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

Study Design
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Study Type : Observational
Estimated Enrollment : 900 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 31, 2013
Estimated Primary Completion Date : December 31, 2029
Estimated Study Completion Date : December 31, 2029

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Groups and Cohorts
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Group/Cohort
Patients with JIA who are treated with Abatacept
Patients with JIA who are treated with Abatacept according to physicians'/families' decisions


Outcome Measures
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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
Serum

Eligibility Criteria
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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
Criteria

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)
Contacts and Locations
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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


Contacts
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Contact: For participation information at a USA site use a phone number below. For Site information outside USA please email: 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

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site For FDA Safety Alerts and Recalls refer to the following link  This link exits the ClinicalTrials.gov site Investigator Inquiry Form  This link exits the ClinicalTrials.gov site

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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: May 2, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents