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An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

This study is currently recruiting participants.
Verified February 2013 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01357668
First received: May 19, 2011
Last updated: February 21, 2013
Last verified: February 2013
History of Changes

May 19, 2011
February 21, 2013
January 2013
June 2028   (final data collection date for primary outcome measure)
  • Incidence rate of serious infections [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of malignancies [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Incidence rate of autoimmune disorders [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01357668 on ClinicalTrials.gov Archive Site
  • Number of serious adverse events [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
  • Number of targeted infections (Epstein-Barr virus, cytomegalovirus, papilloma virus, herpes zoster, tuberculosis and opportunistic infections) [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis
An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

The purpose of this study is to examine the long-term safety of Abatacept for the treatment of juvenile idiopathic arthritis (JIA) in routine clinical practice, with particular in interest in the occurrence of serious infections, autoimmune disorders, and malignancies.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Serum
Non-Probability Sample

Pediatric rheumatology clinics
Juvenile Idiopathic Arthritis
Not Provided
Patients with JIA who are treated with Abatacept
Patients with JIA who are treated with Abatacept according to physicians'/families' decisions
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
900
June 2028
June 2028   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of JIA (any subtype).
  • Age < 18 years at the time of enrollment.
  • Receiving Abatacept at the time of enrollment as per treating physician's decision.
  • 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).
Both
up to 17 Years
No
Not Provided
United States
 
NCT01357668
IM101-240
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Mayers Squibb Bristol-Mayers Squibb
Bristol-Myers Squibb
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP