Comparison of the efficacy of intrarticular corticosteroid therapy administered alone or in combination with methotrexate in children with juvenile idiopatic arthritis: a phase II, randomized acticely controlled, multicenter trial - ND
- Conditions
- juvenile idiopatic arthritisMedDRA version: 9.1Level: LLTClassification code 10059176Term: Juvenile idiopathic arthritis
- Registration Number
- EUCTR2008-006741-70-IT
- Lead Sponsor
- ISTITUTO GIANNINA GASLINI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
patients with AIG by ILAR criteria
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
patients who have received an IAC injection in any joint in the three months before enrollment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate wheter the concomitant administration of methotrexate leads to a significant prolongation of the efficacy of intrarticular corticosteroid therapy in children with oligoarticular-onset juvenile idiopatic arthritis;Secondary Objective: duration of clinical remission defined as the time interval between the IAC injection and the recurrence of the signs of active synovitis or in case of no recurrence the last follow up visit;Primary end point(s): clinical remission
- Secondary Outcome Measures
Name Time Method