Arthritis, Rheumatoid
Conditions
Keywords
Apoptotic cells
Brief summary
The aim of the study is to determine the tolerance of apoptotic autologous cells injection in subjects with active rheumatoid arthritis.
Interventions
BIOLOGICALAutologous apoptotic cells injection
cells injection
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of Rheumatoid arthritis * Therapy failure with at least one biological agent from anti-TNF-alpha (etanercept, infliximab, adalimumab, certolizumab and golimumab; 3 months at optimal dose), anti-IL6 (tocilizumab; 3 months); T-cell costimulatory pathway inhibitor (abatacept; 3 months); anti-CD20 (rituximab; 6 months at optimal dose); Anti IL-1 (anakinra; 3 months) * Disease Activity Score (DAS) DAS28 ≥ 3.2 * Subject has provided written informed consent
Exclusion criteria
* Pregnant or lactating women * Inflammatory arthritis other than rheumatoid arthritis * History of invasive cancer * Immunodeficiency (HIV infection, Immunosuppressive therapy) * Active bacterial or viral infections, in particular HCV or HBV. * Surgery not older than 4 weeks. * Unstable comorbidities: uncontrolled diabetes, heart disease, advanced renal or hepatic impairment. * Contraindication to an apheresis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance of apoptotic cells injection | 12 weeks | Side effects are taken into account to assess tolerance. |
Contacts
Primary ContactCharline Vauchy, PhD
Backup ContactElise Robert
Outcome results
None listed