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

Sponsor

University Hospital, Tours (Other)

Overall Status

Completed

CT.gov ID

NCT03416543

Collaborator

(none)

Enrollment

Location

47.8

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis Gout Osteoarthritis	Other: Puncture

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 The first results in PBMC (unpublished yet) show an increase of the production of IL-10 In this study, we are going to first evaluate the cellular composition of synovial fluid from patients with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

Study Type:

Observational

Actual Enrollment :

45 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 13, 2017

Actual Primary Completion Date :

Dec 8, 2021

Actual Study Completion Date :

Dec 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.	Other: Puncture Puncture necessary for daily practice in patients with acute arthritis of RA or Gout or osteoarthritis

Arm

Intervention/Treatment

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.

Other: Puncture

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

Outcome Measures

Primary Outcome Measures

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

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 IFN [48 hours]
Evaluate the production of IFN 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rheumatology Department, University Hospital, Tours	Tours		France	37044

Sponsors and Collaborators

University Hospital, Tours

Investigators

Principal Investigator: Denis MULLEMAN, MD-PhD, University Hospital, Tours

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Tours

ClinicalTrials.gov Identifier:

NCT03416543

Other Study ID Numbers:

RIPH3-RNI17/BIC RA
2017-A02678-45
17 11 16

First Posted:

Jan 31, 2018

Last Update Posted:

Dec 23, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Tours

Rheumatoid arthritis

Dendritics cells

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Inflammation

Study Results

No Results Posted as of Dec 23, 2021