The present study was designed for the follow up of two groups of patients with JIA, in whom remission was achieved using MTX. In group 1 treatment with MTX will be discontinued as early as 6 months after documentation of remission on medication. In group 2 treatment with MTX will be discontinued later than 12 mpnths after documentation of remission on medication.
Conditions
Interventions
Trade Name: Metotrexato
Product Name: Methotrexate
Pharmaceutical Form: Tablet
Trade Name: Methotrexate
Product Name: Methotrexate
Product Code: L01BA01
Pharmaceutical Form: Solution for injection
Sponsors
Istituto Giannina Gaslini-PRINTO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be included at first confirmation of remission on medication, i.e. after clinically documented inactive disease for at least 3 months (no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; no elevation in ESR or/and CRP attributable to JIA; physician’s global assessment of disease activity indicates no disease activity) (23). At times -3 months patients may be ONLY on a combination of non-steroidal anti-inflammatory drugs (NSAIDs), low-dose steroids (0.2 mg/kg/day or 10 mg/day whichever is lower), and MTX (max 15 mg/m2/week); all the other drugs (eg biologics) must have been withdrawn before this date according to the physician decision. At inclusion into this study patients will be considered being in clinically documented remission on medication 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: Treatment with steroids in the month before remission is first documented. Treatment with biologics, other DMARDs, intraarticular joint injections etc in the 3 months before remission is first documented
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study has the main goal to find out if methotrexate could be safely stopped after 6 months or if it is betterto stop after 12 months of continuous clinical remission;Secondary Objective: Evaluate whether methotrexate therapy should be continued, and how long for, even in the absence of any symptoms. identify risk factors that enable to predict the relapses of the disease.;Primary end point(s): Criteria for definition of remission: 1. No joints with active arthritis 2. No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; 3. No active uveitis (to be defined); 4. No elevation in ESR or/and CRP attributable to JIA (if both are tested, both should be normal); 5. Physician’s global assessment of disease activity indicates no disease activity (i.e. less than VAS scale 1 cm); 6. Clinical Remission On Medication. The criteria for clinical remission must be met for a minimum of six continuous months while the patient is on medication in order for the patient to be considered to be in a state of clinical remission on medication. 7. Clinical Remission Off Medication: the criteria for clinical remission must be met for a minimum of 12 continuous months while off all anti-arthritis and anti-uveitis medication in order for the patient to be considered to be in a state of clinical remission off medication. Definition of flare: Occurrence of any sign of active arthritis and/or active systemic symptoms. | — |
Countries
Denmark, Italy, Spain
Outcome results
None listed