An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 800
- 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
- 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 & 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 (59)
Local Institution - 0060
🇺🇸Little Rock, Arkansas, United States
Local Institution - 0001
🇺🇸Princeton, New Jersey, United States
Local Institution - 0059
🇺🇸Cincinnati, Ohio, United States
Local Institution - 0025
🇦🇹Bregenz, Austria
Local Institution - 0002
🇦🇹Innsbruck, Austria
Local Institution - 0032
🇦🇹Vienna, Austria
Local Institution - 0010
🇧🇷Botucatu, Sao Paulo, Brazil
Local Institution - 0028
🇧🇷São Paulo, SAO Paulo, Brazil
Local Institution - 0026
🇧🇷Campinas, São Paulo, Brazil
Local Institution - 0027
🇧🇷Rio De Janeiro, Brazil
Local Institution - 0029
🇨🇦Calgary, Alberta, Canada
Local Institution - 0011
🇨🇦Montreal, Quebec, Canada
Local Institution - 0035
🇩🇰Aarhus, Midtjylland, Denmark
Local Institution - 0012
🇩🇰Copenhagen, Denmark
Local Institution - 0040
🇫🇷Clermont-ferrand, Puy-de-Dôme, France
Local Institution - 0005
🇫🇷Paris Cedex 15, France
Local Institution - 0041
🇫🇷Toulouse cedex 9, France
Local Institution - 0003
🇩🇪Bad Bramstedt, Germany
Local Institution - 0030
🇩🇪Berlin, Germany
Local Institution - 0034
🇩🇪Freiburg, Germany
Local Institution - 0031
🇩🇪Hamburg, Germany
Local Institution - 0033
🇩🇪Heidelberg, Germany
Local Institution - 0016
🇬🇷Thessaloniki, Greece
Local Institution - 0017
🇭🇺Budapest, Hungary
Local Institution - 0014
🇮🇱Jerusalem, Israel
Local Institution - 0042
🇮🇹Firenze, Italy
Local Institution - 0015
🇮🇹Genova, Italy
Local Institution - 0043
🇮🇹Naples, Italy
Local Institution - 0045
🇮🇹Napoli, Italy
Local Institution - 0044
🇮🇹Padova, Italy
Local Institution - 0046
🇮🇹Trento, Italy
Local Institution - 0018
🇱🇻Riga, Latvia
Local Institution - 0006
🇲🇽Guadalajara, Jalisco, Mexico
Local Institution - 0047
🇳🇱Rotterdam, Netherlands
Local Institution - 0019
🇳🇱Utrecht, Netherlands
Local Institution - 0048
🇳🇴Tromso, Norway
Local Institution - 0049
🇳🇴Trondheim, Norway
Local Institution - 0007
🇵🇪Lima, Peru
Local Institution - 0050
🇵🇪Lima, Peru
Local Institution - 0020
🇵🇹Lisboa, Portugal
Local Institution - 0023
🇵🇷Bayamon, Puerto Rico
Local Institution - 0056
🇵🇷Bayamon, Puerto Rico
Local Institution - 0021
🇷🇴Cluj-Napoca, Romania
Local Institution - 0051
🇷🇺Moscow, Russian Federation
Local Institution
🇷🇺Moscow, Russian Federation
Local Institution - 0053
🇷🇺Saint-Petersburg, Russian Federation
Local Institution - 0052
🇷🇺Saratov, Russian Federation
Local Institution - 0055
🇸🇦Jeddah, Saudi Arabia
Local Institution - 0024
🇸🇦Riyadh 11426, Saudi Arabia
Local Institution - 0022
🇸🇰Piestany, Slovakia
Local Institution - 0009
🇿🇦Pretoria, Gauteng, South Africa
Local Institution - 0057
🇿🇦Panorama, Cape Town, Western CAPE, South Africa
Local Institution - 0058
🇿🇦Pretoria, South Africa
Local Institution - 0036
🇪🇸Sant Joan Despí, Barcelona, Spain
Local Institution - 0004
🇪🇸Barcelona, Spain
Local Institution - 0038
🇪🇸Madrid, Spain
Local Institution - 0037
🇪🇸Murcia, Spain
Local Institution - 0039
🇪🇸Valencia, Spain
Local Institution - 0013
🇬🇧Bristol, United Kingdom