Juvenile Idiopathic Arthritis
Conditions
Interventions
Trade Name: Methotrexate
Product Name: Methotrexate
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Leiden University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age between 4 to 17 years (at the time of JIA diagnosis); - Diagnosed with JIA by their physician as defined by the ILAR-classification; - Able to speak or understand Dutch; - Patients (or parents/guardians of the patient under the age of 12) are able to give informed consent; - Achieve a good MTX response based on the JADAS (Juvenile Arthritis Disease Activity Score) assessing inactive disease scores at 6 months after MTX onset, with a score of 3 or lower or based on the pediatric rheumatologist's opinion. Are the trial subjects under 18? yes Number of subjects for this age range: 132 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: - DMARD use at the moment of inclusion; or MTX experience previously - Alternative route of MTX administration than oral (e.g. subcutaneous) - Concomitant treatment with an experimental drug or procedure interfering with this study purposes - Systemic JIA - Development of uveitis which needs to be treated with a DMARD - Elevated hepatic enzyme levels (serum aspartate transaminase [AST], serum alanine transaminase [ALT] > 2 times normal value) - Bone marrow suppression as lymphocyte count 150 umol/l or estimated creatinine clearance of < 75% - Biologicals
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study’s objective is to reduce MTX related side effects with pharmacotherapeutic conditioning, by using variable reinforcement principles in patients with JIA. Pharmacotherapeutic conditioning enables to alternate standard MTX dosing with lower MTX doses, by utilizing learning effects (conditioning). By this, children with JIA will be less affected by MTX related side effects, without compromising for its therapeutic efficacy. A reduction in side effects will be assessed by intolerance percentages as defined by a cutoff score of = 6 on the Methotrexate Intolerance Severity Score (MISS) questionnaire.;Secondary Objective: Secondary outcome measures are achieving low disease activity as measured by the Juvenile Arthritis Disease Activity Score (JADAS < 3), side effects as determined by liver function and gastrointestinal bleeding, laboratory assessments (e.g., cytokine levels and myeloid-related proteins and MTX polyglutamates), and self-report outcomes as assessed by validated scales about pain and burden of disease.;Primary end point(s): The primary outcome parameter is the difference in percentage of patients who experience MTX intolerance as defined by the Methotrexate Intolerance Severity Score (MISS) with a cut-off score of = 6 between the control and intervention (conditioning) groups, after 9 months of interventon. The primary outcome measure MISS will be measured at month 15. The study will close with an end-of-study visit at month 18 where early flare-ups and side effects will be monitored.;Timepoint(s) of evaluation of this end point: Month 15: Primary outcome measure, MISS | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Month 15: Secondary outcome measures: side effects as determined by liver function and gastrointestinal bleeding, laboratory assessments (e.g., cytokine levels and myeloid-related proteins and MTX polyglutamates), and self-report outcomes as assessed by validated scales about pain and burden of disease. Month 18: Follow-up;Timepoint(s) of evaluation of this end point: Month 15 and 18 | — |
Countries
Netherlands
Contacts
Public ContactInstitute of Psychology
Leiden University
Outcome results
None listed