juvenile idiopatic arthritis MedDRA version: 9.1 Level: LLT Classification code 10059176 Term: Juvenile idiopathic arthritis
Conditions
Interventions
Trade Name: METHOTREXATE*25CPR 2,5MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Methotrexate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Sponsors
ISTITUTO GIANNINA GASLINI
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: patients who have received an IAC injection in any joint in the three months before enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed