Tolerogenic dendritic cell therapy for rheumatoid arthritis.

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

- 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
protocol

Exclusion Criteria

- 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
baseline
- 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
entry
- Major surgery within 8 weeks of baseline or planned within 12 weeks from
baseline
- 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
failure
- Individuals of child bearing potential unwilling to use adequate
contraception for dura-tion of study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcomes are the occurrence of (serious) adverse events including<br /><br>flares of disease activity in the four treatment groups, and the feasibility of<br /><br>generating sufficient numbers of TolDCB29 from RA patient apheresis product. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are the qualitative and quantitative B29-specific T cell<br /><br>response to treatment and the general immune reactivity to TolDCB29<br /><br>administration. Our exploratory objective is the impact of the treatment on<br /><br>clinical parameters. </p><br>