CHAMP Trial: comparing monotherapy and polytherapy treatment strategies in newly diagnosed juvenile idiopathic arthritis.

Phase 1

• Conditions: Juvenile idiopathic arthritis; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2014-003260-20-NL
• Lead Sponsor: eiden University Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-17
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

- Patients with persistent or extended oligoarticular JIA, RF-negative polyarticular JIA, RF-positive polyiarticular JIA, psoriatic JIA, enthesitis- related JIA or undifferentiated JIA according to ILAR Classification criteria
-Active synovitis
-Requiring DMARD therapy according to the treating pediatric rheumatologist. In case of persistent oligoarticular JIA this means patients with poor clinical prognostic factors, for example according to Beukelman
-Age between 2-16 years
-Treated in one of the Dutch paediatric rheumatology centers
-A maximum of 18 months of symptoms

Are the trial subjects under 18? yes
Number of subjects for this age range: 130
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

- Systemic onset Juvenile Idiopathic Arthritis
- JIA with monoarthritis of a knee
-Previous treatment with DMARDs (including study medication) or biological
-Any concurrent illness that would constitute an increased risk for side effects of medication, is associated with an increased risk for severe infections or in the opinion of the treating physician is a contraindication for treatment with any of the initial therapies or participation in the trial as such.
-Current or prior history of blood dyscrasias. Abnormal safety baseline blood test e.g. haemoglobin = 5 mmol/l; haematocrit = 27%; platelet count = 125 x 109 /L; white blood cell count = 3.5x 109 /L; serum creatinine = 2 times the laboratory’s upper limit of normal; aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) = 2 times the laboratory’s upper limit of normal.
-Pregnancy

Study & Design

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