|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 April 2022 |
|
Main ID: |
NCT02903212 |
|
Date of registration:
|
01/09/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis
APO-RA |
|
Scientific title:
|
Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis |
|
Date of first enrolment:
|
March 2023 |
|
Target sample size:
|
22 |
|
Recruitment status: |
Not yet recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02903212 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1/Phase 2
|
|
|
Contacts
|
|
Name:
|
Charline Vauchy, PhD |
|
Address:
|
|
|
Telephone:
|
+33381218875 |
|
Email:
|
cvauchy@chu-besancon.fr |
|
Affiliation:
|
|
|
|
Name:
|
Eric Toussirot, Professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Rhumatology - CHU Besançon |
| |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Arthritis, Rheumatoid
|
|
Intervention(s)
|
|
Biological: Autologous apoptotic cells injection
|
|
Primary Outcome(s)
|
|
Tolerance of apoptotic cells injection
[Time Frame: 12 weeks]
|
|
Secondary ID(s)
|
|
P/2013/196
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|