Juvenile idiopathic arthritis
Conditions
Interventions
Trade Name: Methotrexate
Pharmaceutical Form: Tablet
INN or Proposed INN: METHOTREXATE
Current Sponsor code: METHOTREXATE
Other descriptive name: METHOTREXATE
Concentration unit: mg milligram(s)
Conce
Sponsors
Leiden University Medical Centre
Eligibility
Sex/Gender
All
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study whether polytherapy (methotrexate plus sulfasalazine plus hydroxychloroquine) results in more patients with inactive disease and therefore less patient who have proceeded to treatment with a TNF inhibitor after 6 months of treatment compared to primary MTX monotherapy in children with newly diagnosed JIA.;Secondary Objective: -To compare side effects and tolerability of treatment in both treatment arms -To compare the number of patients that are treated with a TNF inhibitor after 12 months of treatment in both arms - To compare the number of patients that need to switch to subcutaneous MTX after 3 months of treatment in both treatment arms - To compare 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 - To compare functional ability and quality of life in both treatment arms - To provide cost-effectiveness data concerning the first year of DMARD therapy in both groups - To identify possible predictors of response, such as serologic markers, urinary markers, genetic biomarkers and faecal microbiota. ;Primary end point(s): The primary endpoint of the study is the number of patients in both treatment strategies who have inactive disease after 6 months of treatment.;Timepoint(s) of evaluation of this end point: After 6 months of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The number of (serious) adverse events in both study arms throughout the study - The number of patients that are treated with a TNF inhibitor after 12 months of treatment in both treatment arms - The number of patients who need to switch to MTX subcutaneously at 3 months after start of therapy. - ACR pedi scores (30, 50, 70, 90) in both treatment arms at 3, 6, 9 and 12 months and inactive disease after 3, 9 and 12 months of treatment - Functional ability and quality of life in both treatment groups, measured with CHAQ and CHQ questionnaires - Costs of the first year after initiation of treatment in both treatment arms - Biomarkers for disease activity (such as chemokines, cytokines, genetic markers, fecal microbiota) in plasma, urine and feces ;Timepoint(s) of evaluation of this end point: From baseline up to 12 months. | — |
Countries
Netherlands
Contacts
Public ContactD. M. C. Brinkman
Leiden University Medical Centre
Outcome results
None listed