A randomised trial of 6 months versus 12 months withdrawal of methotrexate in patiebts with juvenile idiopathic arthritis in clinical remission.Ensayo aleatorizado de retirada de Metotrexate a los 6 meses versus a los 12 meses, en pacientes con Artritis Idiopática Juvenil (AIJ) en remisión clínica - MTX withdrawal study

• Conditions: 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.

• Registration Number: EUCTR2005-001086-34-ES
• Lead Sponsor: Istituto Giannina Gaslini-PRINTO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-20
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

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or 10 mg/day whichever is lower), and MTX (max 15 mg/m2/week); all the other drugs (eg biologics) must have been withdrawn before this date according to the physician decision.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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified