Study of the Articular Microbiota in Rheumatoid Arthritis.

NCT04056234 | Completed

• 1 other identifier: CHU BX 2011/12
• Study Type: observational
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The cause of rheumatoid arthritis (RA) remains unknown, although major advances have been done these last ten years in the comprehension of its pathophysiology. The aim of this study is to described a synovial microbiota specific for rheumatoid arthritis.

Conditions

Rheumatoid Arthritis; Synovial Disorder; Arthrosis

Keywords

Translocation; Synovial microbiota

Outcome Measures

Primary Outcomes (2)

• Presence of bacterial DNA by 16s PCR

  Detection by 16s PCR of DNA of bacterial origin in synovial fluid specimens

  At the screening

• Presence of a characteristic microbiota

  Research of a characteristic microbiota of rheumatoid arthritis

  At the screening

Study Arms (2)

Rheumatoid arthritis group

Patients with rheumatoid arthritis

Procedure: Joint puncture

Control group

Patients with osteoarthritis / joint effusion.

Procedure: Joint puncture

Interventions

Joint puncture PROCEDURE

Patient requiring joint puncture for diagnostic or therapeutic reasons.

Control group; Rheumatoid arthritis group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a pilot study. The number of subjets will be 12 RA patients and 6 controls suffering from osteoarthritis.

You may qualify if:

• patients presenting with RA according to ACR87 and ACR/EULAR 2010 criteria
• patients presenting with RA anti-citrullinated peptide antibodies positive
• patients presenting with active RA, characterized by at least one synovitis
• patients presenting with an arthritis requiring arthrocentesis and synovial fluid collection for diagnostic or therapeutic purpose
• patients giving agreement to participate to the study and to sign informed consent.

You may not qualify if:

• patients suffering from osteoarthritis
• patients presenting with joint effusion justifying an arthrocentesis and synovial fluid collection for diagnostic of therapeutic purpose
• patients giving agreement to participate to the study and to sign informed consent
• Patients presenting with another arthropathy than anti-citrullinated peptide antibodies positive RA or osteoarthritis
• Patients not requiring arthrocentesis for medical reasons
• Patients refusing to sign informed consent
• Patients presenting with understanding problems due to language or cognitive reasons.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

The joint fluid samples will be obtained from residues of samples taken for diagnostic or therapeutic purposes.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoarthritis

Interventions

Arthrocentesis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Emilie SHIPLEY, Dr

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 14, 2019
• Study Start: February 21, 2012
• Primary Completion: February 22, 2013
• Study Completion: February 22, 2013
• Last Updated: August 14, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share