A randomised trial of 6 months versus 12 months withdrawal of methotrexate in patients with Juvenile Idiopathic Arthritis (JIA) in clinical remissio

Completed

• Conditions: Juvenila Idiopathic Arthritis (JIA); Musculoskeletal Diseases; Juvenila idiopathic arthritis

• Registration Number: ISRCTN18186313
• Lead Sponsor: Pediatric Rheumatology International Trials Organisation (PRINTO) (Italy) and Wyeth Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Patients will be included at first confirmation of remission on medication i.e. after clinically documented inactive disease for at least three months (no joints with active arthritis, no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA, no active uveitis, no elevation in Erythrocyte Sedimentation Rate [ESR] and/or C-Reactive Protein [CRP] attributable to JIA, physician?s global assessment of disease activity indicates no disease activity).

At three months, patients may be only be on a combination of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), low-dose steroids (0.2 mg/kg per day or 10 mg per day whichever is lower), and MTX (max 15 mg/m^2 per week); all the other drugs (e.g. biologics) must have been withdrawn before this date according to the physician?s decision.

Before inclusion into this study (study time point 0 months), patients will be considered to be in clinically documented remission on medication. At this time point, all medications other than NSAIDs and MTX with a dose range of 10 to 15 mg/m^2 per week have to be withdrawn. After discontinuation of MTX (study time point 6 i.e. after 6 months in group 1; study time point 12 i.e. after 12 months in group 2) treatment with NSAIDs should be stopped.

Exclusion Criteria

Patients should not have received intra-articular corticosteroids up to three months prior to inclusion

Study & Design

• Study Type: Interventional
• Study Design: Not specified