rheumatoid arthritis
Conditions
Interventions
Study participants will receive two intranodal injections with the TolDCB29
product with a four week interval. During the first phase of the study dose
escalation is performed, in which the first gr
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes are the occurrence of (serious) adverse events including flares of disease activity in the four treatment groups, and the feasibility of generating sufficient numbers of TolDCB29 from RA patient apheresis product. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are the qualitative and quantitative B29-specific T cell response to treatment and the general immune reactivity to TolDCB29 administration. Our exploratory objective is the impact of the treatment on clinical parameters. | — |
Countries
Netherlands
Outcome results
None listed