Training immune functions through pharmacotherapeutic conditioning injuvenile idiopathic arthritis - OPTI-MISS

eiden University0 个研究点目标入组 132 人开始时间: 2018年5月23日最近更新: 2018年5月28日

适应症

试验速览

暂无简介。

•- 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

发起方

eiden University