Faecal Analyses in Rheumatoid Arthritis Therapy (FART)

Region Skane

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: MTX start; Drug: TNF start

Study type: Observational

Funder types: Other

Identifiers

NCT03775824

FART1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Rheumatoid arthritis according to the 2010 classification criteria
• About to start methotrexate or TNF-inhibitor because of active disease

Exclusion criteria

• Failure to understand protocol
• A history of alcohol abuse
• Concomitant inflammatory bowel disease
• Any history of diverticulitis
• A history of failure to comply with prescribed medication
• Ongoing biological therapy

Trial design

50 participants in 2 patient groups

MTX start

Description:

Patients with active rheumatoid arthritis who are either naive to methotrexate, or have not used this medicine in the last year and who are about to start therapy with methotrexate i.v. or s.c.

Treatment:

Drug: MTX start

TNF start

Description:

Patients with active rheumatoid arthritis who are either naive to TNF-inhibitors, or have not used this medicine in the last year and who are about to start therapy with any of the following (biosimilars included); infliximab, adalimumab, etanercept, certolizumab or golimumab

Treatment:

Drug: TNF start