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Faecal Analyses in Rheumatoid Arthritis Therapy (FART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775824
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Kristofer Andreasson, Region Skane

Tracking Information
First Submitted Date December 11, 2018
First Posted Date December 14, 2018
Last Update Posted Date September 16, 2019
Actual Study Start Date August 1, 2016
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 19, 2018)
  • 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
  • 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/
  • 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.
Original Primary Outcome Measures
 (submitted: December 11, 2018)
  • 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
  • Change in gut flora [ Time Frame: Change from baseline Dysbiosis Index Score at 6 months ]
    Change in intestinal gut flora assessed by Dysbiosis Index Score at follow up compared to baseline
  • Change in disease activity/treatment response at follow up [ Time Frame: Change from baseline DAS-28 at 6 months ]
    Change in rheumatoid arthritis disease activity based on Disease Activity Score 28 (DAS-28), a Composite index of disease activity between 0-10, where 10 equals maximum activity
Change History
Current Secondary Outcome Measures
 (submitted: December 19, 2018)
  • Adherance to immunosuppressive therapy [ Time Frame: Analysis made at 6 months follow up ]
    Is the patient still prescribed the same immunosuppressant compared to baseline?
  • 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
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: December 11, 2018)
  • Drug survival [ Time Frame: Analysis made at 6 months follow up ]
    Patient still taking drug at follow up
  • Change in concentration of specific gut bacteria [ Time Frame: Change from baseline concentration at 6 months ]
    Alterations in intestinal concentrations of the following bacteria; Prevotella, Lactobacillus and Clostridia
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Faecal Analyses in Rheumatoid Arthritis Therapy
Official Title Faecal Analyses in Rheumatoid Arthritis Therapy: An Prospective Observational Study of the Intestinal Microbiome in Patients With Rheumatoid Arthritis Receiving Immunosuppressive Therapy
Brief 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Faecal and blood samples from study participants are stored in a biorepository.
Sampling Method Non-Probability Sample
Study Population

This study encompasses consecutive patients with rheumatoid arthritis who by their physician at the Rheumatology Clinic, Skåne University Hospital, have been prescribed any of the predefined drugs.

Patients who are willing to comply with the study protocoll are included.

The study population is consequently not a sample, but encompasses a majority of patients being prescribed theses medications at our University clinic.

Condition Rheumatoid Arthritis
Intervention
  • Drug: MTX start
    Patient prescribed MTX s.c. or p.o. because of active rheumatoid arthritis
    Other Name: MTX
  • Drug: TNF start
    Patient prescribed TNF-inhibitor because of active rheumatoid arthritis
    Other Name: TNF
Study Groups/Cohorts
  • MTX start
    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.
    Intervention: Drug: MTX start
  • TNF start
    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
    Intervention: Drug: TNF start
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: December 11, 2018)
50
Original Estimated Enrollment Same as current
Actual Study Completion Date June 1, 2019
Actual Primary Completion Date November 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03775824
Other Study ID Numbers FART1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Kristofer Andreasson, Region Skane
Study Sponsor Region Skane
Collaborators Not Provided
Investigators
Principal Investigator: Kristofer Andréasson, MD PhD Skane University Hospital
PRS Account Region Skane
Verification Date September 2019