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

Primary Purpose

Arthritis, Rheumatoid

Status

Not yet recruiting

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Autologous apoptotic cells injection

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Apoptotic cells

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rheumatoid arthritis

Arm Description

Patients with rheumatoid arthritis. An injection of autologous apoptotic cells is performed on the D0.

Outcomes

Primary Outcome Measures

Tolerance of apoptotic cells injection

Side effects are taken into account to assess tolerance.

Secondary Outcome Measures

Full Information

NCT ID

NCT02903212

First Posted

September 1, 2016

Last Updated

April 5, 2022

Sponsor

Centre Hospitalier Universitaire de Besancon

1. Study Identification

Unique Protocol Identification Number

NCT02903212

Brief Title

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

Acronym

APO-RA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

March 2023 (Anticipated)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Rheumatoid

Keywords

Apoptotic cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rheumatoid arthritis

Arm Type

Experimental

Arm Description

Patients with rheumatoid arthritis. An injection of autologous apoptotic cells is performed on the D0.

Intervention Type

Biological

Intervention Name(s)

Autologous apoptotic cells injection

Intervention Description

cells injection

Primary Outcome Measure Information:

Title

Tolerance of apoptotic cells injection

Description

Side effects are taken into account to assess tolerance.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Charline Vauchy, PhD

Phone

+33381218875

cvauchy@chu-besancon.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Elise Robert

Phone

0381219086

e1robert@chu-besancon.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric Toussirot, Professor

Organizational Affiliation

Rhumatology - CHU Besançon

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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