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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
  Purpose

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.


Condition
Juvenile Idiopathic Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

Resource links provided by NLM:

Drug Information available for: Abatacept
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 900
Study Start Date: January 2013
Estimated Study Completion Date: June 2028
Estimated Primary Completion Date: June 2028 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with JIA who are treated with Abatacept
Patients with JIA who are treated with Abatacept according to physicians'/families' decisions

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric rheumatology clinics

Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357668

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Hermine Brunner, Site 001     513-803-4328        
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Mayers Squibb Bristol-Mayers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  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

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01357668     History of Changes
Other Study ID Numbers: IM101-240
Study First Received: May 19, 2011
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board
European Union: European Medicines Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013