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

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Osteoarthritis; Gout; Rheumatoid Arthritis

Treatments: Other: Puncture

Study type: Observational

Funder types: Other

Identifiers

NCT03416543

17 11 16 (Other Identifier)

2017-A02678-45 (Other Identifier)

RIPH3-RNI17/BIC RA

Details and patient eligibility

About

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.

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 The first results in PBMC (unpublished yet) show an increase of the production of IL-10 In this study, we are going to first evaluate the cellular composition of synovial fluid from patients with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

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

45 participants in 1 patient group

Puncture

Description:

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.

Treatment:

Other: Puncture