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

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ClinicalTrials.gov Identifier: NCT03416543
Recruitment Status : Recruiting
First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief Summary:

First, this study will evaluate, in vitro, the cellular composition of the synovial fluid from patient with rheumatoid arthritis or gout.

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 IL-6 and IFN will be checked as well.


Condition or disease Intervention/treatment
Rheumatoid Arthritis Gout Arthritis 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 The first results in PBMC (unpublished yet) show an increase of the production of IL-10 In this study, we are going to first evaluate the cellular composition of synovial fluid from patients with RA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) Then, we will use this new antibody and evaluate the response by dosing Il-10, IL-6 and IFN.

The aim is to verify in vitro if, with this new drug, it is possible to reverse the inflammation and induce a tolerance.


Study Type : Observational
Estimated Enrollment : 12 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 : January 8, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Puncture
Patient with RA or gout 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Production of Il-6 [ Time Frame: 48 hours ]
    Evaluate the production of IL-6 by cells from synovial fluid after the use of a new antibody format

  2. Production of IFN [ Time Frame: 48 hours ]
    Evaluate the production of IFN by cells from synovial fluid after the use of a new antibody format


Biospecimen Retention:   Samples Without DNA
synovial fluid


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with acute arthritis of RA or Gout. Puncture necessary for daily practice (diagnostic or therapeutic)
Criteria

Inclusion Criteria:

  • Male or female over 18 years old
  • Proven and possible RA or Gout
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416543


Contacts
Contact: Denis MULLEMAN, MD-PhD 02.47.47.59.17 ext +33 denis.mulleman@univ-tours.fr
Contact: Guillaume LE MELEDO 02.47.47.59.17 ext +33 guillaume.lemeledo@etu.univ-tours.fr

Locations
France
Rheumatology department, University Hospital, Tours Recruiting
Tours, France, 37044
Contact: Denis MULLEMAN, MD-PhD    02.47.47.59.17 ext +33    denis.mulleman@univ-tours.fr   
Contact: Guillaume LE MELEDO    02.47.47.59.17 ext +33    guillaume.lemeledo@etu.univ-tours.fr   
Principal Investigator: Denis MULLEMAN, MD-PhD         
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Denis MULLEMAN, MD-PhD University Hospital, Tours

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT03416543     History of Changes
Other Study ID Numbers: RIPH3-RNI17/BIC RA
2017-A02678-45 ( Other Identifier: IdRCB )
17 11 16 ( Other Identifier: CPP )
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Tours:
Rheumatoid arthritis
Dendritics cells

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Antibodies
Immunoglobulins
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs