Status:
UNKNOWN
Pharmacovigilance in Juvenile Idiopathic Arthritis Patients Treated With Biologic Agents and/or Methotrexate
Lead Sponsor:
Istituto Giannina Gaslini
Collaborating Sponsors:
Members of the PRINTO network (PRINTO at www.printo.it)
Conditions:
Juvenile Idiopathic Arthritis
Eligibility:
All Genders
6-30 years
Brief Summary
BACKGROUND: Juvenile idiopathic arthritis (JIA) is the most common chronic paediatric rheumatic disease (PRD) and an important cause of short and long-term disability. Although none of the available d...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- Contraindications to biologic agents and/or MTX treatment
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
9000 Patients enrolled
Trial Details
Trial ID
NCT01399281
Start Date
December 1 2011
End Date
December 1 2021
Last Update
March 5 2018
Active Locations (1)
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1
IRCCS G. Gaslini
Genoa, Italy, 16147