NCT02903212

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
6.5 years until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

1.3 years

First QC Date

September 1, 2016

Last Update Submit

April 5, 2022

Conditions

Arthritis, Rheumatoid

Keywords

Apoptotic cells

Outcome Measures

Primary Outcomes (1)

  • Tolerance of apoptotic cells injection

    Side effects are taken into account to assess tolerance.

    12 weeks

Study Arms (1)

Rheumatoid arthritis

EXPERIMENTAL

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

Biological: Autologous apoptotic cells injection

Interventions

Autologous apoptotic cells injectionBIOLOGICAL

cells injection

Rheumatoid arthritis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Eric Toussirot, Professor

    Rhumatology - CHU Besançon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charline Vauchy, PhD

CONTACT

+33381218875cvauchy@chu-besancon.fr

Elise Robert

CONTACT

0381219086e1robert@chu-besancon.fr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 16, 2016

Study Start

March 1, 2023

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share