Status:
UNKNOWN
Tolerogenic Dendritic Cell Therapy for Rheumatoid Arthritis
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Radboud University Medical Center
Utrecht University
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Rationale: In rheumatoid arthritis, immune cells cause joint inflammation and destruction in response to autoantigens. Immunosuppressive therapies offer relief but fail to induce tolerance to autoanti...
Eligibility Criteria
Inclusion
- Diagnosis of rheumatoid arthritis (RA) according to the criteria which were valid at time of diagnosis (i.e. 1987 Rheumatoid Arthritis Classification or 2010 American College of Rheumatology/EULAR RA Classification Criteria)
- Stable dose, for at least 12 weeks, of any combination of disease-modifying antirheumatic 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 for at least 12 weeks (disease activity score of 28 joints \< 3.2)
- Able and willing to give informed consent and to comply with the study protocol
Exclusion
- Intramuscular or intra-articular glucocorticoid injection during 12 weeks prior to inclusion
- 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; alanine aminotransferase or alkaline phosphatase\>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. chronic obstructive pulmonary disease, cardiac failure
- Individuals of child bearing potential unwilling to use adequate contraception for duration the of study
Key Trial Info
Start Date :
August 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05251870
Start Date
August 17 2021
End Date
August 1 2025
Last Update
February 23 2022
Active Locations (3)
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1
Radboud University Medical Centre
Nijmegen, Netherlands
2
University Medical Centre Utrecht
Utrecht, Netherlands
3
Utrecht University
Utrecht, Netherlands