juvenile idiopathic arthritis (JIA) Dutch: juveniele idiopathische artritis (JIA)
Conditions
Interventions
Arm 1: methotrexate monotherapy
Arma 2: combination therapy with methotrexate, sulfasalazine en hydroxychloroquine
Sponsors
Leiden University Medical Centre
Eligibility
Inclusion criteria
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 Beukelman7 - Age between 2-16 years - Treated in one of the Dutch paediatric rheumatology centres - A maximum of 18 months of symptoms
Exclusion criteria
Exclusion criteria: - Systemic onset Juvenile Idiopathic Arthritis - Patients with oligoarticular JIA with mono-arthritis of a knee - Previous treatment with DMARDs (including study medication) or a 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 ¡Ü 5 mmol/l; haematocrit ¡Ü 27%; platelet count ¡Ü 125 x 109 /L; white blood cell count ¡Ü 3.5x 109 /L; serum creatinine ¡Ý 2 times the laboratory¡¯s upper limit of normal; aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) ¡Ý 2 times the laboratory¡¯s upper limit of normal. - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients with inactive disease after 6 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| - Side effects and tolerability of treatment in both treatment arms - Number of patients that are treated with a TNF inhibitor after 12 months of treatment in both arms - The number of patients that need to switch to subcutaneous MTX after 3 months of treatment in both treatment arms - 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 - Functional ability and quality of life in both treatment arms - Cost-effectiveness data concerning the first year of DMARD therapy in both groups - Possible predictors of response, such as serologic and genetic markers | — |
Contacts
Public ContactLeontien van der Aa
Albinusdreef 2
Outcome results
None listed