CHAMP: Children with Arthritis: Monotherapy or Polytherapy. A multicentre, single-blinded, randomized treat to target, one-year follow-up clinical trial in patients with recent onset Juvenile Idiopathic Arthritis (JIA).

Recruiting

Conditions: arthritis
juvenile idiopathic arthritis
10003816
10023213

Registration Number: NL-OMON53043

Lead Sponsor: Kindergeneeskunde

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

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;

Exclusion Criteria

- Systemic onset Juvenile Idiopathic Arthritis - 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.
- Pregnancydie in meerd

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study is the number of patients in both treatment<br /><br>strategies who have active disease after 6 months of treatment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To compare side effects and tolerability of treatment in both treatment<br /><br>arms<br /><br>- To compare the number of patients that are treated with a TNF inhibitor after<br /><br>12 months of treatment in both arms<br /><br>- To compare the number of patients that need to switch to subcutaneous MTX<br /><br>after 3 months of treatment in both treatment arms<br /><br>- To compare ACR Pedi scores (30, 50, 70, 90) in both treatment groups at 3,<br /><br>6, 9, and 12 months and the number of patients with inactive disease at 3, 9<br /><br>and 12 months of treatment<br /><br>- To compare functional ability and quality of life in both treatment arms<br /><br>- To provide cost-effectiveness data concerning the first year of DMARD therapy<br /><br>in both groups<br /><br>- To identify possible predictors of response such as serologic markers,<br /><br>urinary markers, genetic biomarkers and faecal microbiota</p><br>