An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01357668
First received: May 19, 2011
Last updated: October 9, 2014
Last verified: October 2014

May 19, 2011
October 9, 2014
January 2013
June 2029   (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) 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 2029
June 2029   (final data collection date for primary outcome measure)

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).
Both
up to 17 Years
No
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
United States,   Argentina,   Austria,   Brazil,   Canada,   Denmark,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Latvia,   Mexico,   Netherlands,   Portugal,   Puerto Rico,   Russian Federation,   Spain,   United Kingdom
 
NCT01357668
IM101-240
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
October 2014

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