Arthritis, RheumatoidPhase 1/2APO-RANCT02903212
Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis
A Phase 1/2 study testing Autologous apoptotic cells injection in people with Arthritis, Rheumatoid, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
The aim of the study is to determine the tolerance of apoptotic autologous cells injection in subjects with active rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Autologous apoptotic cells injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
The aim of the study is to determine the tolerance of apoptotic autologous cells injection in subjects with active rheumatoid arthritis.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Autologous apoptotic cells injection
- Keywords
- Apoptotic cells
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous apoptotic cells injectionBiological
cells injection
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis | Experimental | Patients with rheumatoid arthritis. An injection of autologous apoptotic cells is performed on the D0. Receives: Biological: Autologous apoptotic cells injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of apoptotic cells injection
Side effects are taken into account to assess tolerance.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study startMar 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Toussirot, Professor, Principal investigator, Rhumatology - CHU Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903212
- Sponsor's protocol ID
- P/2013/196
- Acronym
- APO-RA
- Status last verified
- Apr 2022
- First submitted
- 1 Sep 2016
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02903212
- Acronym / sponsor ID
- APO-RA / P/2013/196
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Apoptotic cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to determine the tolerance of apoptotic autologous cells injection in subjects with active rheumatoid arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis | Experimental | Biological: Autologous apoptotic cells injectionPatients with rheumatoid arthritis. An injection of autologous apoptotic cells is performed on the D0. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous apoptotic cells injectioncells injection | Biological | Rheumatoid arthritis |
Primary outcome
Tolerance of apoptotic cells injection
Time frame: 12 weeks
Side effects are taken into account to assess tolerance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Toussirot, Professor principal investigator
Rhumatology - CHU Besançon
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous apoptotic cells injection in people with Arthritis, Rheumatoid, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charline Vauchy, PhD (+33381218875, cvauchy@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance of apoptotic cells injection (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.