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

Completed

• Conditions: Osteoarthritis; Rheumatoid Arthritis; Gout
• Interventions: Other: Puncture

• Registration Number: NCT03416543
• Lead Sponsor: University Hospital, Tours

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 The first results in PBMC (unpublished yet) show an increase of the production of IL-10 In this study, we are going to first evaluate the cellular composition of synovial fluid from patients with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

Study Timeline

• Study Start: 2017-12-13
• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-31
• Status Verified: 2021-12
• Primary Completion: 2021-12-08
• Study Completion: 2021-12-08
• Last Update Submitted: 2021-12-22
• Last Update Posted: 2021-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Puncture	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.

Primary Outcome Measures

Name	Time	Method
Production of IL-10	48 hours	Evaluate the production of IL-10 by cells from synovial fluid after the use of a new antibody format

Secondary Outcome Measures

Name	Time	Method
Production of IFN	48 hours	Evaluate the production of IFN by cells from synovial fluid after the use of a new antibody format
Production of Il-6	48 hours	Evaluate the production of IL-6 by cells from synovial fluid after the use of a new antibody format
Production of IL1B	48 hours	Evaluate the production of IL1B by cells from synovial fluid after the use of a new antibody format
Production of IL12	48 hours	Evaluate the production of IL12 by cells from synovial fluid after the use of a new antibody format

Trial Locations

Locations (1)

Rheumatology Department, University Hospital, Tours; 🇫🇷 Tours, France