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

NCT03416543 | Completed

• 3 other identifiers: RIPH3-RNI17/BIC RA2017-A02678-4517 11 16
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Gout; Osteoarthritis

Keywords

Rheumatoid arthritis; Dendritics cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Production of Il-6

  48 hours

• Production of IFN

  48 hours

• Production of IL1B

  48 hours

• Production of IL12

  48 hours

Study Arms (1)

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

Interventions

Puncture OTHER

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

Puncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute arthritis of RA or Gout or with osteoarthritis. Puncture necessary for daily practice (diagnostic or therapeutic)

You may qualify if:

• 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

You may not qualify if:

• Microcrystalline rheumatism other than Gout
• Known SpA
• Septic arthritis
• Biomedicament treatment
• Patient having objected to the processing of his data

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

Rheumatology Department, University Hospital, Tours

Tours, 37044, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

synovial fluid

MeSH Terms

Conditions

Arthritis, Rheumatoid; Gout; Osteoarthritis

Interventions

Punctures

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Denis MULLEMAN, MD-PhD

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: January 31, 2018
• Study Start: December 13, 2017
• Primary Completion: December 8, 2021
• Study Completion: December 8, 2021
• Last Updated: December 23, 2021

Record last verified: 2021-12

Locations

FR (1)