The aim of the study is to determine the tolerance of apoptotic autologous cells injection in subjects with active rheumatoid arthritis.
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: June 2021
- Biological: Autologous apoptotic cells injection
- cells injection
Arms, Groups and Cohorts
- Experimental: Rheumatoid arthritis
- Patients with rheumatoid arthritis. An injection of autologous apoptotic cells is performed on the D0.
Clinical Trial Outcome Measures
- Tolerance of apoptotic cells injection
- Time Frame: 12 weeks
- Side effects are taken into account to assess tolerance.
Participating in This Clinical Trial
- 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
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- Provider of Information About this Clinical Study
- Overall Official(s)
- Eric Toussirot, Professor, Principal Investigator, Rhumatology – CHU Besançon
- Overall Contact(s)
- Charline Vauchy, PhD, +33381218875, firstname.lastname@example.org
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