Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis
NCT ID: NCT02903212
Last Updated: 2022-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
22 participants
INTERVENTIONAL
2023-03-31
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rheumatoid arthritis
Patients with rheumatoid arthritis. An injection of autologous apoptotic cells is performed on the D0.
Autologous apoptotic cells injection
cells injection
Interventions
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Autologous apoptotic cells injection
cells injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Principal Investigators
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Eric Toussirot, Professor
Role: PRINCIPAL_INVESTIGATOR
Rhumatology - CHU Besançon
Central Contacts
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Other Identifiers
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P/2013/196
Identifier Type: -
Identifier Source: org_study_id
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