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Clinical Trials/NCT03416543
NCT03416543
Completed
Not Applicable

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

University Hospital, Tours1 site in 1 country45 target enrollmentDecember 13, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rheumatoid Arthritis
Sponsor
University Hospital, Tours
Enrollment
45
Locations
1
Primary Endpoint
Production of IL-10
Status
Completed
Last Updated
4 years ago

Overview

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 The first results in PBMC (unpublished yet) show an increase of the production of IL-10 In this study, we are going to first evaluate the cellular composition of synovial fluid from patients with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

Registry
clinicaltrials.gov
Start Date
December 13, 2017
End Date
December 8, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Production of Il-6(48 hours)
  • Production of IFN(48 hours)
  • Production of IL1B(48 hours)
  • Production of IL12(48 hours)

Study Sites (1)

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