An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis

Active, not recruiting

• Conditions: Juvenile Idiopathic Arthritis

• Registration Number: NCT01357668
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2011-05-19
• Study First Submitted QC: 2011-05-20
• Study First Posted: 2011-05-23
• Study Start: 2013-01-30
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2029-01-02
• Study Completion: 2029-01-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 800

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate of serious infections	10 years
Incidence rate of malignancies	10 years
Incidence rate of autoimmune disorders	10 years

Secondary Outcome Measures

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

Trial Locations

Locations (26)

Local Institution - 0001; 🇺🇸 Princeton, New Jersey, United States

Local Institution - 0026; 🇧🇷 Campinas, São Paulo, Brazil

Local Institution - 0002; 🇦🇹 Innsbruck, Austria

Local Institution - 0010; 🇧🇷 Botucatu, Sao Paulo, Brazil

Local Institution - 0011; 🇨🇦 Montreal, Quebec, Canada

Local Institution - 0012; 🇩🇰 Copenhagen, Denmark

Local Institution - 0025; 🇦🇹 Bregenz, Austria

Local Institution - 0005; 🇫🇷 Paris Cedex 15, France

Local Institution - 0003; 🇩🇪 Bad Bramstedt, Germany

Local Institution - 0015; 🇮🇹 Genova, Italy

Local Institution - 0018; 🇱🇻 Riga, Latvia

Local Institution - 0016; 🇬🇷 Thessaloniki, Greece

Local Institution - 0017; 🇭🇺 Budapest, Hungary

Local Institution - 0014; 🇮🇱 Jerusalem, Israel

Local Institution - 0006; 🇲🇽 Guadalajara, Jalisco, Mexico

Local Institution - 0019; 🇳🇱 Utrecht, Netherlands

Local Institution - 0007; 🇵🇪 Lima, Peru

Local Institution - 0020; 🇵🇹 Lisboa, Portugal

Local Institution - 0023; 🇵🇷 Bayamon, Puerto Rico

Local Institution - 0021; 🇷🇴 Cluj-Napoca, Romania

Local Institution; 🇷🇺 Moscow, Russian Federation

Local Institution - 0024; 🇸🇦 Riyadh 11426, Saudi Arabia

Local Institution - 0022; 🇸🇰 Piestany, Slovakia

Local Institution - 0009; 🇿🇦 Pretoria, Gauteng, South Africa

Local Institution - 0004; 🇪🇸 Barcelona, Spain

Local Institution - 0013; 🇬🇧 Bristol, United Kingdom