An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

May 1, 2023 updated by: Bristol-Myers Squibb
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time

Study Locations

  • Austria
      • Innsbruck, Austria, A-6020
        • Recruiting
        • Local Institution - 0002
  • Brazil
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18618-970
        • Recruiting
        • Local Institution - 0010
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • Local Institution - 0011
  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Local Institution - 0012
  • France
      • Paris Cedex 15, France, 75743
        • Recruiting
        • Local Institution - 0005
  • Germany
      • Bad Bramstedt, Germany, 24576
        • Completed
        • Local Institution - 0003
  • Greece
      • Thessaloniki, Greece, 54642
        • Recruiting
        • Local Institution - 0016
  • Hungary
      • Budapest, Hungary, H-1023
        • Recruiting
        • Local Institution - 0017
  • Israel
      • Jerusalem, Israel, 91031
        • Completed
        • Local Institution - 0014
  • Italy
      • Genova, Italy, 16147
        • Recruiting
        • Local Institution - 0015
  • Latvia
      • Riga, Latvia, LV-1007
        • Recruiting
        • Local Institution - 0018
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44620
        • Recruiting
        • Local Institution - 0006
  • Netherlands
      • Utrecht, Netherlands, 3584 EA
        • Recruiting
        • Local Institution - 0019
  • Peru
      • Lima, Peru, 1
        • Recruiting
        • Local Institution - 0007
  • Portugal
      • Lisboa, Portugal, 1600
        • Recruiting
        • Local Institution - 0020
  • Puerto Rico
      • Bayamon, Puerto Rico, PR 960
        • Completed
        • Local Institution - 0023
  • Romania
      • Cluj-Napoca, Romania
        • Recruiting
        • Local Institution - 0021
  • Russian Federation
      • Moscow, Russian Federation, 119991
        • Terminated
        • Local Institution
  • Saudi Arabia
      • Riyadh 11426, Saudi Arabia, 11426
        • Recruiting
        • Local Institution - 0024
  • Slovakia
      • Piestany, Slovakia
        • Recruiting
        • Local Institution - 0022
  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0002
        • Recruiting
        • Local Institution - 0009
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Local Institution - 0004
  • United Kingdom
      • Bristol, United Kingdom, BS2 8BJ
        • Completed
        • Local Institution - 0013
  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Recruiting
        • Bristol-Myers Squibb, Active
        • Contact:
          • Mr Bristol-Myers Squibb, Site 0001
          • Phone Number: 609-252-7230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric rheumatology clinics

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence rate of serious infections
Time Frame: 10 years
10 years
Incidence rate of malignancies
Time Frame: 10 years
10 years
Incidence rate of autoimmune disorders
Time Frame: 10 years
10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of serious adverse events
Time Frame: 10 years
10 years
Number of targeted infections (Epstein-Barr virus, cytomegalovirus, papilloma virus, herpes zoster, tuberculosis and opportunistic infections)
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2013

Primary Completion (Anticipated)

January 2, 2029

Study Completion (Anticipated)

January 2, 2029

Study Registration Dates

First Submitted

May 19, 2011

First Submitted That Met QC Criteria

May 20, 2011

First Posted (Estimate)

May 23, 2011

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 1, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM101-240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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