Tolerogenic dendritic cell therapy for rheumatoid arthritis. - TOLERANT

niversitair Medisch Centrum Utrecht0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•- Diagnosis of rheumatoid arthritis according to the criteria which were valid
•at time of diagnosis (i.e. 1987 Rheumatoid Arthritis Classification or 2010
•ACR/EULAR RA Classification Criteria).
•- Age 18 years or older
•- Stable dose, for at least 12 weeks, of any combination of disease-modifying
•anti-rheumatic drugs and glucocorticoids (maximum of 7,5 mg per day), with
•exception of those drugs that are part of the exclusion criteria.
•- Disease in remission or in low disease activity, measured by disease activity
•score of 28 joints < 3.2 for at least 12 weeks
•- Able and willing to give informed consent and to comply with the study

•- Intramuscular or intra-articular glucocorticoid injection during 12 weeks
•prior to inclu-sion
•- Use of JAK inhibitors
•- Active or chronic infection (except fungal nail infection)
•- Infection requiring hospitalization or IV antibiotics within 6 weeks of
•- Immunization with live vaccine within 6 weeks of baseline
•- History of malignancy (except treated basal cell carcinoma of skin)
•- Use of other investigational medicinal products within 30 days prior to study
•- Major surgery within 8 weeks of baseline or planned within 12 weeks from
•- Pregnancy, or women planning to become pregnant within the study period, or
•women who are breast feeding
•- Hb<6 mmol/L; neutrophils< 2.00 x10^9/L; platelets <150x10^9/L;
•ALT/ALP>2x upper limit of normal; renal insufficiency (clearance < 60
•ml/min) at screening visit.
•- Poor venous access or medical condition precluding leukapheresis
•- Serious or unstable co-morbidity deemed unsuitable by PI, e.g. COPD, cardiac
•- Individuals of child bearing potential unwilling to use adequate
•contraception for dura-tion of study

发起方

niversitair Medisch Centrum Utrecht