An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

NCT ID: NCT01357668

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-30

Study Completion Date

2029-01-02

Brief Summary

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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.

Detailed Description

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Conditions

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Juvenile Idiopathic Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with JIA who are treated with Abatacept

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

No interventions assigned to this group

Eligibility Criteria

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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).
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0060

Little Rock, Arkansas, United States

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Local Institution - 0001

Princeton, New Jersey, United States

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Local Institution - 0059

Cincinnati, Ohio, United States

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Local Institution - 0025

Bregenz, , Austria

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Innsbruck, , Austria

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Local Institution - 0032

Vienna, , Austria

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Botucatu, São Paulo, Brazil

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Local Institution - 0026

Campinas, São Paulo, Brazil

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Local Institution - 0028

São Paulo, São Paulo, Brazil

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Local Institution - 0027

Rio de Janeiro, , Brazil

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Local Institution - 0029

Calgary, Alberta, Canada

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Montreal, Quebec, Canada

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Local Institution - 0035

Aarhus, Central Jutland, Denmark

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Local Institution - 0012

Copenhagen, , Denmark

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Clermont-Ferrand, Puy-de-Dôme, France

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Local Institution - 0005

Paris, , France

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Toulouse, , France

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Bad Bramstedt, , Germany

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Berlin, , Germany

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Freiburg im Breisgau, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Thessaloniki, , Greece

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Budapest, , Hungary

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Jerusalem, , Israel

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Local Institution - 0042

Florence, , Italy

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Genova, , Italy

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Naples, , Italy

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Napoli, , Italy

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Padua, , Italy

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Trento, , Italy

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Riga, , Latvia

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Local Institution - 0006

Guadalajara, Jalisco, Mexico

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Local Institution - 0047

Rotterdam, , Netherlands

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Local Institution - 0019

Utrecht, , Netherlands

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Local Institution - 0048

Tromsø, , Norway

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Trondheim, , Norway

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Local Institution - 0007

Lima, , Peru

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Local Institution - 0050

Lima, , Peru

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Lisbon, , Portugal

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Local Institution - 0023

Bayamón, , Puerto Rico

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Local Institution - 0056

Bayamón, , Puerto Rico

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Local Institution - 0021

Cluj-Napoca, , Romania

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Local Institution - 0051

Moscow, , Russia

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Moscow, , Russia

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Local Institution - 0053

Saint Petersburg, , Russia

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Saratov, , Russia

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Local Institution - 0055

Jeddah, , Saudi Arabia

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Local Institution - 0024

Riyadh, , Saudi Arabia

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Local Institution - 0022

Piešťany, , Slovakia

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Local Institution - 0009

Pretoria, Gauteng, South Africa

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Local Institution - 0057

Panorama, Cape Town, Western Cape, South Africa

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Local Institution - 0058

Pretoria, , South Africa

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Local Institution - 0036

Sant Joan Despí, Barcelona, Spain

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Local Institution - 0004

Barcelona, , Spain

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Local Institution - 0038

Madrid, , Spain

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Local Institution - 0037

Murcia, , Spain

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Local Institution - 0039

Valencia, , Spain

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Local Institution - 0013

Bristol, , United Kingdom

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Countries

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United States Austria Brazil Canada Denmark France Germany Greece Hungary Israel Italy Latvia Mexico Netherlands Norway Peru Portugal Puerto Rico Romania Russia Saudi Arabia Slovakia South Africa Spain United Kingdom

References

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Lovell DJ, Tzaribachev N, Henrickson M, Simonini G, Griffin TA, Alexeeva E, Bohnsack JF, Zeft A, Horneff G, Vehe RK, Stanevica V, Tarvin S, Trachana M, Del Rio AQ, Huber AM, Kietz D, Orban I, Dare J, Foeldvari I, Quartier P, Dominique A, Simon TA, Martini A, Brunner HI, Ruperto N; for PRINTO and the Pediatric Rheumatology Collaborative Study Group (PRCSG) section sign. Safety and effectiveness of abatacept in juvenile idiopathic arthritis: results from the PRINTO/PRCSG registry. Rheumatology (Oxford). 2024 Sep 1;63(SI2):SI195-SI206. doi: 10.1093/rheumatology/keae025.

Reference Type DERIVED
PMID: 38243722 (View on PubMed)

Related Links

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Other Identifiers

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IM101-240

Identifier Type: -

Identifier Source: org_study_id

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