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Completed

NCT Number: NCT03416543

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Crystal Arthropathies Genetic Diseases, Inborn Gout Immune System Diseases Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoarthritis Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rheumatology Department, University Hospital, Tours

Tours, 37044, France

About this study

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 The first results in PBMC (unpublished yet) show an increase of the production of IL-10 In this study, we are going to first evaluate the cellular composition of synovial fluid from patients with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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Puncture

Other

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

Primary outcomes

  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 outcomes

  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

  3. Production of IL1B

    Time frame: 48 hours

    Evaluate the production of IL1B by cells from synovial fluid after the use of a new antibody format

  4. Production of IL12

    Time frame: 48 hours

    Evaluate the production of IL12 by cells from synovial fluid after the use of a new antibody format

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: BIC_RA

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jan 31, 2018
Registry last updated
Dec 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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