Pharmacovigilance in Juvenile Idiopathic Arthritis Patients Treated With Biologic Agents and/or Methotrexate
Launched by ISTITUTO GIANNINA GASLINI · Jul 20, 2011
Trial Information
Current as of June 20, 2025
Unknown status
Keywords
ClinConnect Summary
Study Design This is a 3-10 year, international, multicentre, observational, safety and efficacy (response, joint erosion, damage, and treatment adherence) study aimed at collecting prospective safety, tolerability, efficacy, and treatment adherence information on JIA subjects exposed to any biologic agents and MTX, according to local standard of practice.
This is a non-interventional study, where the medicinal products are prescribed as per the investigator's decision. The assignment of the subject to a particular therapeutic strategy is not decided in advance by the study protocol, but f...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Signed written informed consent by subjects and /or parent or legally acceptable representative;
- • JIA (any ILAR category);
- • Subjects receiving biologic agents ± MTX, MTX alone, or NSAIDs and/or steroid injections only as per physician discretion.
- Exclusion Criteria:
- • Contraindications to biologic agents and/or MTX treatment
About Istituto Giannina Gaslini
Istituto Giannina Gaslini is a renowned pediatric research institute located in Genoa, Italy, dedicated to advancing child health through innovative clinical research and high-quality care. As a leading center in pediatric medicine, the institute focuses on a wide range of specialties, including oncology, immunology, and rare diseases. Committed to improving patient outcomes, Istituto Giannina Gaslini actively engages in clinical trials that explore new therapeutic strategies and enhance existing treatments. With a multidisciplinary team of experts, the institute fosters collaboration with national and international partners to contribute to the global body of pediatric medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Genoa, , Italy
Patients applied
Trial Officials
Nicola Ruperto, MD, MPH
Principal Investigator
Istituto G. Gaslini/ PRINTO
PRINTO Member
Study Director
All PRINTO members who will receive ethics committee approval
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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