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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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