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Trial record 1 of 1 for:    APO-RA
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Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis (APO-RA)

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ClinicalTrials.gov Identifier: NCT02903212
Recruitment Status : Not yet recruiting
First Posted : September 16, 2016
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Biological: Autologous apoptotic cells injection Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rheumatoid arthritis
Patients with rheumatoid arthritis. An injection of autologous apoptotic cells is performed on the D0.
Biological: Autologous apoptotic cells injection
cells injection




Primary Outcome Measures :
  1. Tolerance of apoptotic cells injection [ Time Frame: 12 weeks ]
    Side effects are taken into account to assess tolerance.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02903212


Contacts
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Contact: Charline Vauchy, PhD +33381218875 cvauchy@chu-besancon.fr
Contact: Elise Robert 0381219086 e1robert@chu-besancon.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Eric Toussirot, Professor Rhumatology - CHU Besançon
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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02903212    
Other Study ID Numbers: P/2013/196
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Besancon:
Apoptotic cells
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases