Training immune functions through pharmacotherapeutic conditioning in juvenile idiopathic arthritis

Phase 3

Withdrawn

Conditions: Juvenile idiopathic arthritis / Juvenile Arthritis
10003816

Registration Number: NL-OMON46548

Lead Sponsor: niversiteit Leiden

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 132

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.

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 <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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameter is the difference in percentage of patients who<br /><br>experience MTX intolerance as defined by the Methotrexate Intolerance Severity<br /><br>Score (MISS) with a cut-off score of * 6 between the control and intervention<br /><br>(conditioning) groups.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are achieving low disease activity as measured by<br /><br>the Juvenile Arthritis Disease Activity Score (JADAS < 3), side effects as<br /><br>determined by liver function and gastrointestinal bleeding, laboratory<br /><br>assessments (e.g., cytokine levels and myeloid-related proteins and MTX<br /><br>polyglutamates), and self-report outcomes as assessed by validated scales about<br /><br>pain and burden of disease. </p><br>