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

Completed

• Conditions: juvenile idiopathic arthritis; 10023213

• Registration Number: NL-OMON40476
• Lead Sponsor: Westfaelische Wilhelm Universitaet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-12-27
• Results First Posted: 2022-02-24
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 33

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 Steroids must have been withdrawn at least 1 month before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.

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.
Patients who are not followed for pharmacovigilance in our anonymized Pharmachild-database.

Study & Design

• Study Type: Interventional
• Study Design: Not specified