Reducing side effects from methotrexate in juvenile arthritis treatment
- Conditions
- Juvenile Idiopathic ArthritisTherapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]
- Registration Number
- EUCTR2018-001571-21-NL
- Lead Sponsor
- eiden University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 132
- 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
- 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 <0.9×109/L, granulocyte count <1.5×109/L and/or thrombocyte count <20 × 109/L.39
- Serum creatinine levels > 150 umol/l or estimated creatinine clearance of < 75%
- Biologicals
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method