Rheumatoid Arthritis
Conditions
Interventions
Product Name: tolDCB29
Pharmaceutical Form: Suspension for injection in pre-filled syringe
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
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 =65 years) yes F.1.3.1 Number of subjects for this age range 3
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 - Hb2x 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 |
|---|---|
| Main Objective: • Determining the safety (occurrence of adverse events and disease flares) and tolerability of intranodal TolDCB29 administration. • Determining the feasibility of clinical grade TolDCB29 production from RA patient apheresis product ;Secondary Objective: • Demonstrating the qualitative and quantitative effects on HSP70/B29-specific T cells in response to TolDCB29 therapy • Evaluating the general characteristics of immune reactivity in response to TolDCB29 administration ;Primary end point(s): The first primary endpoint is the toxicity of the treatment at 20 weeks after the second TolDCB29 administration, defined as: • The occurrence of severe adverse events from administration of the first dose of TolDCB29 onwards • The occurrence of disease flares, defined as an increase in Disease Activity Score in 28 joints of >1.2 (or >0.6 if the former DAS28 was = 3.2). The second primary endpoint is the feasibility to generate sufficient numbers of TolDCB29 for the planned dose administrations to each participant;Timepoint(s) of evaluation of this end point: 20 weeks after the second TolDCB29 administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The induction and/or activation of HSP70/B29 specific T cells in response to TolDCB29 therapy 2. The general immune reactivity in response to TolDCB29 administration;Timepoint(s) of evaluation of this end point: 4, 8, 12, and 24 weeks after the first TolDCB29 administration | — |
Countries
Netherlands
Contacts
Public ContactPrincipal Investigator
University Medical Center Utrecht
Outcome results
None listed