Children with arthritis: monotherapy or polytherapy?
- Conditions
- juvenile idiopathic arthritis (JIA)Dutch: juveniele idiopathische artritis (JIA)
- Registration Number
- NL-OMON29408
- Lead Sponsor
- eiden University Medical Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- 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
Exclusion Criteria
- Systemic onset Juvenile Idiopathic Arthritis
- Patients with oligoarticular JIA with mono-arthritis of a knee
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The number of patients with inactive disease after 6 months of treatment
- Secondary Outcome Measures
Name Time Method - Side effects and tolerability of treatment in both treatment arms<br /><br>- Number of patients that are treated with a TNF inhibitor after 12 months of treatment in both arms<br /><br>- The number of patients that need to switch to subcutaneous MTX after 3 months of treatment in both treatment arms<br /><br>- ACR Pedi scores (30, 50, 70, 90) and clinical JADAS scores in both treatment groups at 3, 6, 9, and 12 months and the number of patients with inactive disease at 3, 9 and 12 months of treatment<br /><br>- Functional ability and quality of life in both treatment arms<br /><br>- Cost-effectiveness data concerning the first year of DMARD therapy in both groups <br /><br>- Possible predictors of response, such as serologic and genetic markers <br><br> <br>