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NCT Number: NCT01357668

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution - 0025, Bregenz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2013
Primary completion
2029
Study completion
2029
First posted
May 23, 2011
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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