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Completed

NCT Number: NCT03775824

Faecal Analyses in Rheumatoid Arthritis Therapy

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dysbiosis Immune System Diseases Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

MTX start

Drug

Patient prescribed MTX s.c. or p.o. because of active rheumatoid arthritis

Other names: MTX

TNF start

Drug

Patient prescribed TNF-inhibitor because of active rheumatoid arthritis

Other names: TNF

Primary outcomes

  1. Intestinal gut flora in rheumatoid arthritis

    Time frame: Analysis made at study start/baseline

    Intestinal gut flora based on DNA-based microbial analysis of fecal samples

  2. Change in gut flora

    Time frame: Change from baseline Dysbiosis Index Score at 6 months

    Change in Dysbiosis Index Score at follow up compared to baseline.

    The Dysbiosis Index Score measures degree of intestinal dysbiosis on a scale from 1 to 5, where 5 indicates dysbiosis. The Index has been extensively described at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5029765/

  3. Change in disease activity/treatment response at follow up

    Time frame: Change from baseline DAS-28 at 6 months

    Change in Disease Activity Score 28 (DAS-28), an established index of disease activity in rheumatoid arthritis between 0-10, where 10 equals maximum activity.

Secondary outcomes

  1. Adherance to immunosuppressive therapy

    Time frame: Analysis made at 6 months follow up

    Is the patient still prescribed the same immunosuppressant compared to baseline?

  2. Change in intestinal concentration Prevotella

    Time frame: Change from baseline concentration at 6 months

    Alterations in intestinal concentrations of Prevotella bacteria according to polymerase chain reaction (PCR)-based analysis

  3. Change in intestinal concentration Lactobacillus

    Time frame: Change from baseline concentration at 6 months

    Alterations in intestinal concentrations of Lactobacillus bacteria according to PCR-based analysis

  4. Change in intestinal concentration Clostridia

    Time frame: Change from baseline concentration at 6 months

    Alterations in intestinal concentrations of Clostridia bacteria according to PCR-based analysis

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

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

Acronym: FART

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Dec 14, 2018
Registry last updated
Sep 16, 2019

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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