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Effect of a New BI-specifiC Antibody Towards Dendritic Cells on Inflammation in Rheumatoid Arthritis

Effect of a New BI-specifiC Antibody Towards Dendritic Cells on Inflammation in Rheumatoid Arthritis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03416543
Acronym
BIC_RA
Enrollment
45
Registered
2018-01-31
Start date
2017-12-13
Completion date
2021-12-08
Last updated
2021-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis, Gout, Osteoarthritis

Keywords

Rheumatoid arthritis, Dendritics cells

Brief 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. 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 The first results in PBMC (unpublished yet) show an increase of the production of IL-10 In this study, we are going to first evaluate the cellular composition of synovial fluid from patients with RA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.

Interventions

Puncture necessary for daily practice in patients with acute arthritis of RA or Gout or osteoarthritis

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Microcrystalline rheumatism other than Gout * Known SpA * Septic arthritis * Biomedicament treatment * Patient having objected to the processing of his data

Design outcomes

Primary

MeasureTime frameDescription
Production of IL-1048 hoursEvaluate the production of IL-10 by cells from synovial fluid after the use of a new antibody format

Secondary

MeasureTime frameDescription
Production of Il-648 hoursEvaluate the production of IL-6 by cells from synovial fluid after the use of a new antibody format
Production of IFN48 hoursEvaluate the production of IFN by cells from synovial fluid after the use of a new antibody format
Production of IL1B48 hoursEvaluate the production of IL1B by cells from synovial fluid after the use of a new antibody format
Production of IL1248 hoursEvaluate the production of IL12 by cells from synovial fluid after the use of a new antibody format

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026