NCT03775824

Faecal Analyses in Rheumatoid Arthritis Therapy

Faecal Analyses in Rheumatoid Arthritis Therapy: An Prospective Observational Study of the Intestinal Microbiome in Patients With Rheumatoid Arthritis Receiving Immunosuppressive Therapy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the intestinal microbiome and disease activity in patients with rheumatoid arthritis receiving immunosuppressive therapy. Patients will be analysed at two time points in reference to two predefined primary endpoints: * Changes in intestinal microbiome * Response to therapy The investigators want to evaluate if successful treatment of rheumatoid arthritis coincide with specific changes in the gut flora.

Detailed description

Methotrexate (MTX) and tumor necrosis factor (TNF) -inhibitors are two efficient medications for the treatment of rheumatoid arthritis. In a substantial number of cases however, these medications remain ineffective. At present, the scientific community has limited understanding of why some patients are resistant to these medications. The purpose of this study is to understand if the gut flora may associate with treatment response. Recent studies have associated rheumatoid arthritis with intestinal dysbiosis. Specifically, the bacteria Prevotella copri, has been associated with this disease, an observation that has been supported also by mechanistic studies. In patients receiving methotrexate, normalization of dysbiosis has been associated with successful treatment. This study is of observational character and integrated in the routine clinical care of patients with rheumatoid arthritis at the Rheumatology Clinic, Skane University Hospital, Lund, Sweden. Study participants are asked to deliver blood and fecal sampling at two time-points together with clinical evaluation of disease activity. With an estimated inclusion of 50 patients, at least 20 responders and 20 non-responders are expected to be included and to be compared to each other. If successful treatment response in rheumatoid arthritis is associated with specific alterations of the gut flora, these results may guide future studies on the impact of dysbiosis and probiotics on this disease.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	MTX start	Patient prescribed MTX s.c. or p.o. because of active rheumatoid arthritis
DRUG	TNF start	Patient prescribed TNF-inhibitor because of active rheumatoid arthritis

Timeline

• Start date: 2016-08-01
• Primary completion: 2018-11-01
• Completion: 2019-06-01
• First posted: 2018-12-14
• Last updated: 2019-09-16