Clinical Trials in Spain / NCT01357668
Active, not recruiting
Observational
An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis
NCT01357668 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Juvenile Idiopathic Arthritis
Study 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.
Eligibility
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).
Primary outcome measure(s)
- Incidence rate of serious infections — 10 years
- Incidence rate of malignancies — 10 years
- Incidence rate of autoimmune disorders — 10 years
Trial sites (59)
| Facility | City | Region | Status |
|---|---|---|---|
| Local Institution - 0060 | Little Rock | Arkansas | |
| Local Institution - 0001 | Princeton | New Jersey | |
| Local Institution - 0059 | Cincinnati | Ohio | |
| Local Institution - 0025 | Bregenz | Austria | |
| Local Institution - 0002 | Innsbruck | Austria | |
| Local Institution - 0032 | Vienna | Austria | |
| Local Institution - 0010 | Botucatu | São Paulo | |
| Local Institution - 0026 | Campinas | São Paulo | |
| Local Institution - 0028 | São Paulo | São Paulo | |
| Local Institution - 0027 | Rio de Janeiro | Brazil | |
| Local Institution - 0029 | Calgary | Alberta | |
| Local Institution - 0011 | Montreal | Quebec | |
| Local Institution - 0035 | Aarhus | Central Jutland | |
| Local Institution - 0012 | Copenhagen | Denmark | |
| Local Institution - 0040 | Clermont-Ferrand | Puy-de-Dôme | |
| Local Institution - 0005 | Paris | France | |
| Local Institution - 0041 | Toulouse | France | |
| Local Institution - 0003 | Bad Bramstedt | Germany | |
| Local Institution - 0030 | Berlin | Germany | |
| Local Institution - 0034 | Freiburg im Breisgau | 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 | Florence | Italy | |
| Local Institution - 0015 | Genova | Italy | |
| Local Institution - 0043 | Naples | Italy | |
| Local Institution - 0045 | Naples | Italy | |
| Local Institution - 0044 | Padova | Italy | |
| Local Institution - 0046 | Trento | Italy | |
| Local Institution - 0018 | Riga | Latvia | |
| Local Institution - 0006 | Guadalajara | Jalisco | |
| Local Institution - 0047 | Rotterdam | Netherlands | |
| Local Institution - 0019 | Utrecht | Netherlands | |
| Local Institution - 0048 | Tromsø | Norway | |
| Local Institution - 0049 | Trondheim | Norway | |
| Local Institution - 0007 | Lima | Peru | |
| Local Institution - 0050 | Lima | Peru | |
| Local Institution - 0020 | Lisbon | Portugal |
+ 19 more sites — see the full list on the official registry below.
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT01357668 on ClinicalTrials.gov ↗ ← All trials in Spain