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

Rheumatoid Arthritis Clinical Trial

— BIC_RA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03416543
• Other study ID #: RIPH3-RNI17/BIC RA
• Secondary ID: 2017-A02678-4517
• Status: Completed
• Start date: December 13, 2017
• Est. completion date: December 8, 2021

Study information

• Verified date: December 2021
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Production of others cytokines like IL-1B, IL-6, IL-12 and IFN will be checked as well.

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 The first results in PBMC (unpublished yet) show an increase of the production of IL-10 In this study, we are going to first evaluate the cellular composition of synovial fluid from patients with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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 8, 2021
• Est. primary completion date: December 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Gout
• Inflammation
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
France	Rheumatology Department, University Hospital, Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Production of IL-10	Evaluate the production of IL-10 by cells from synovial fluid after the use of a new antibody format	48 hours
Secondary	Production of Il-6	Evaluate the production of IL-6 by cells from synovial fluid after the use of a new antibody format	48 hours
Secondary	Production of IFN	Evaluate the production of IFN by cells from synovial fluid after the use of a new antibody format	48 hours
Secondary	Production of IL1B	Evaluate the production of IL1B by cells from synovial fluid after the use of a new antibody format	48 hours
Secondary	Production of IL12	Evaluate the production of IL12 by cells from synovial fluid after the use of a new antibody format	48 hours