Rheumatoid ArthritisBIC_RANCT03416543
Effect of a New BI-specifiC Antibody Towards Dendritic Cells on Inflammation in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Gout, run by University Hospital, Tours at 1 site in France.
Trial summary
First, this study will evaluate, in vitro, the cellular composition of the synovial fluid from patient with rheumatoid arthritis, gout or osteoarthritis. Then samples will be test with a new format of bispecific antibody targeting dendritic cells. The production of IL-10 will be the principal criteria of judgment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Gout, Osteoarthritis
- What is being tested?
- Puncture
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2017to 8 Dec 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute arthritis of RA or Gout or with osteoarthritis. Puncture necessary for daily practice (diagnostic or therapeutic)
Who may be able to join
- Male or female over 18 years old
- Proven and possible RA or Gout or osteoarthritis
- Arthritis accessible to a puncture
- Necessary puncture for diagnosis or therapeutic
Who cannot join
- Microcrystalline rheumatism other than Gout
- Known SpA
- Septic arthritis
- Biomedicament treatment
- Patient having objected to the processing of his data
Trial locations and contacts
1 site in 1 country.
About this study
First, this study will evaluate, in vitro, the cellular composition of the synovial fluid from patient with rheumatoid arthritis, gout or osteoarthritis.
Then samples will be test with a new format of bispecific antibody targeting dendritic cells. The production of IL-10 will be the principal criteria of judgment. Production of others cytokines like IL-1B, IL-6, IL-12 and IFN will be checked as well.
Read the detailed description
Rheumatoid arthritis (RA) is one of the most common autoimmune disease in adult. It exists several drugs but none target dendritic cells even if it seems they play a major role in the physiopathology.
One of the unit of research of Tours recently develop a new format of bispecific antibody which target dendritic cells. The first results in PBMC (unpublished yet) show an increase of the production of IL-10 In this study, we are going to first evaluate the cellular composition of synovial fluid from patients with RA and patients with gout (for the comparison, because the inflammatory mechanisms are different) and with osteoarthritis (comparison with a non inflammatory disease) Then, we will use this new antibody and evaluate the response by dosing Il-10, IL-6, IL-12, IL1B and IFNy The aim is to verify in vitro if, with this new drug, it is possible to reverse the inflammation and induce a tolerance.
- Conditions
- Rheumatoid Arthritis, Gout, Osteoarthritis
- Being tested
- Puncture
- Keywords
- Rheumatoid arthritis, Dendritics cells
- Medical subject headings
- Arthritis, Rheumatoid, Gout, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PunctureOther
Puncture necessary for daily practice in patients with acute arthritis of RA or Gout or osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| Puncture | Patient with RA or gout or osteoarthritis and performing a puncture. The aim is evaluate the cellular composition of synovial fluid then evaluate the response to a new BI-specifiC Antibody Towards Dendritic Cells. Receives: Other: Puncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Production of IL-10
Evaluate the production of IL-10 by cells from synovial fluid after the use of a new antibody format
Measured: 48 hours
Secondary outcomes (4)
Production of Il-6
Evaluate the production of IL-6 by cells from synovial fluid after the use of a new antibody format
Measured: 48 hours
Production of IFN
Evaluate the production of IFN by cells from synovial fluid after the use of a new antibody format
Measured: 48 hours
Production of IL1B
Evaluate the production of IL1B by cells from synovial fluid after the use of a new antibody format
Measured: 48 hours
Production of IL12
Evaluate the production of IL12 by cells from synovial fluid after the use of a new antibody format
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start13 Dec 2017
- Primary completion8 Dec 2021
- Study completion8 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Denis MULLEMAN, MD-PhD, Principal investigator, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416543
- Sponsor's protocol ID
- RIPH3-RNI17/BIC RA
- Other IDs
- 2017-A02678-45, 17 11 16
- Acronym
- BIC_RA
- Status last verified
- Dec 2021
- First submitted
- 24 Jan 2018
- Last updated
- 23 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a New BI-specifiC Antibody Towards Dendritic Cells on Inflammation in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03416543
- Acronym / sponsor ID
- BIC_RA / RIPH3-RNI17/BIC RA
- Conditions
- Rheumatoid Arthritis, Gout, Osteoarthritis
- Keywords
- Rheumatoid arthritis, Dendritics cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 13 Dec 2017 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 31 Jan 2018 (actual)
- 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.
First, this study will evaluate, in vitro, the cellular composition of the synovial fluid from patient with rheumatoid arthritis, gout or osteoarthritis.
Then samples will be test with a new format of bispecific antibody targeting dendritic cells. The production of IL-10 will be the principal criteria of judgment. Production of others cytokines like IL-1B, IL-6, IL-12 and IFN will be checked as well.
Detailed description
Rheumatoid arthritis (RA) is one of the most common autoimmune disease in adult. It exists several drugs but none target dendritic cells even if it seems they play a major role in the physiopathology.
One of the unit of research of Tours recently develop a new format of bispecific antibody which target dendritic cells. The first results in PBMC (unpublished yet) show an increase of the production of IL-10 In this study, we are going to first evaluate the cellular composition of synovial fluid from patients with RA and patients with gout (for the comparison, because the inflammatory mechanisms are different) and with osteoarthritis (comparison with a non inflammatory disease) Then, we will use this new antibody and evaluate the response by dosing Il-10, IL-6, IL-12, IL1B and IFNy The aim is to verify in vitro if, with this new drug, it is possible to reverse the inflammation and induce a tolerance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Puncture | – | Other: PuncturePatient with RA or gout or osteoarthritis and performing a puncture. The aim is evaluate the cellular composition of synovial fluid then evaluate the response to a new BI-specifiC Antibody Towards Dendritic Cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute arthritis of RA or Gout or with osteoarthritis. Puncture necessary for daily practice (diagnostic or therapeutic)
Key inclusion criteria (4 listed)
- Male or female over 18 years old
- Proven and possible RA or Gout or osteoarthritis
- Arthritis accessible to a puncture
- Necessary puncture for diagnosis or therapeutic
Key exclusion criteria (5 listed)
- Microcrystalline rheumatism other than Gout
- Known SpA
- Septic arthritis
- Biomedicament treatment
- Patient having objected to the processing of his data
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 |
|---|---|---|
| PuncturePuncture necessary for daily practice in patients with acute arthritis of RA or Gout or osteoarthritis | Other | Puncture |
Primary outcome
Production of IL-10
Time frame: 48 hours
Evaluate the production of IL-10 by cells from synovial fluid after the use of a new antibody format
4 secondary outcomes
Production of Il-6
Time frame: 48 hours
Production of IFN
Time frame: 48 hours
Production of IL1B
Time frame: 48 hours
Production of IL12
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
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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.
Denis MULLEMAN, MD-PhD principal investigator
University Hospital, Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Gout, run by University Hospital, Tours at 1 site in France.
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 5 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: finished, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Production of IL-10 (time frame: 48 hours). 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 23 Dec 2021.