Prevention of disease flares by risk-adapted stratification of therapy withdrawal in juvenile idiopathic arthritis (JIA)

• Conditions: juvenile idiopathic arthritis; MedDRA version: 16.1Level: LLTClassification code 10059177Term: Juvenile arthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-003956-18-NL
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-13
• Last Update Posted: 12 May 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

Patients with polyarticular course of any JIA subcategory (including extended oligoarthritis and polyarticular course of systemic JIA without systemic features) will be included at first confirmation of remission on medication, i.e. after clinically documented inactive disease (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) for at least 6 months. Alternatively patients can be enrolled until 12 months (+/- 6 weeks) to ensure access to the study after 6 months of inactive disease. At the time remission is documented, patients may be ONLY on non-steroidal anti-inflammatory drugs (NSAIDs) plus DMARDs and/or biologics at a stable dose. Only approved medication is allowed during the study. Steroids must have been withdrawn at least 1 month before remission is documented. Intraarticular joint injections should not have been performed 6 months before remission is documented. 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: 70
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 with persistent oligoarthritis subtype or systemic JIA having systemic features (within 1 year prior to inclusion) are excluded.
In addition, patients may not have received treatment with steroids in the month before remission is first documented or treatment with intraarticular joint injections etc. in the 6 months before remission is first documented.
Patient with a history of uveitis or macrophage activation syndrome are excluded.
Patients may also not be included if withdrawal of any biological drug has ever been unsuccessful in the past.

Study & Design

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