Juvenile Idiopathic Arthritis Clinical Trial
Official title:
An Observational Registry of Abatacept in Patients With Juvenile Idiopathic Arthritis
NCT number | NCT01357668 |
Other study ID # | IM101-240 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 30, 2013 |
Est. completion date | January 2, 2029 |
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.
Status | Recruiting |
Enrollment | 800 |
Est. completion date | January 2, 2029 |
Est. primary completion date | January 2, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 17 Years |
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) |
Country | Name | City | State |
---|---|---|---|
Austria | Local Institution - 0002 | Innsbruck | |
Brazil | Local Institution - 0010 | Botucatu | Sao Paulo |
Canada | Local Institution - 0011 | Montreal | Quebec |
Denmark | Local Institution - 0012 | Copenhagen | |
France | Local Institution - 0005 | Paris Cedex 15 | |
Germany | Local Institution - 0003 | Bad Bramstedt | |
Greece | Local Institution - 0016 | Thessaloniki | |
Hungary | Local Institution - 0017 | Budapest | |
Israel | Local Institution - 0014 | Jerusalem | |
Italy | Local Institution - 0015 | Genova | |
Latvia | Local Institution - 0018 | Riga | |
Mexico | Local Institution - 0006 | Guadalajara | Jalisco |
Netherlands | Local Institution - 0019 | Utrecht | |
Peru | Local Institution - 0007 | Lima | |
Portugal | Local Institution - 0020 | Lisboa | |
Puerto Rico | Local Institution - 0023 | Bayamon | |
Romania | Local Institution - 0021 | Cluj-Napoca | |
Russian Federation | Local Institution | Moscow | |
Saudi Arabia | Local Institution - 0024 | Riyadh 11426 | |
Slovakia | Local Institution - 0022 | Piestany | |
South Africa | Local Institution - 0009 | Pretoria | Gauteng |
Spain | Local Institution - 0004 | Barcelona | |
United Kingdom | Local Institution - 0013 | Bristol | |
United States | Bristol-Myers Squibb, Active | Princeton | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States, Austria, Brazil, Canada, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Latvia, Mexico, Netherlands, Peru, Portugal, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Slovakia, South Africa, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence rate of serious infections | 10 years | ||
Primary | Incidence rate of malignancies | 10 years | ||
Primary | Incidence rate of autoimmune disorders | 10 years | ||
Secondary | Number of serious adverse events | 10 years | ||
Secondary | Number of targeted infections (Epstein-Barr virus, cytomegalovirus, papilloma virus, herpes zoster, tuberculosis and opportunistic infections) | 10 years |
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