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NCT02903212 Clinical Trial

Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

— APO-RA  

Official title:
Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02903212
Other study ID # P/2013/196
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 2023
Est. completion date December 2024

Study information
Verified date April 2022
Source Centre Hospitalier Universitaire de Besancon
Contact Charline Vauchy, PhD
Phone +33381218875
Email cvauchy@chu-besancon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to determine the tolerance of apoptotic autologous cells injection in subjects with active rheumatoid arthritis.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 22
Est. completion date December 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Autologous apoptotic cells injection
cells injection

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome
Type Measure Description Time frame Safety issue
Primary Tolerance of apoptotic cells injection Side effects are taken into account to assess tolerance. 12 weeks
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