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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03775824
Date of registration:	11/12/2018
Prospective Registration:	No
Primary sponsor:	Region Skane
Public title:	Faecal Analyses in Rheumatoid Arthritis Therapy FART
Scientific title:	Faecal Analyses in Rheumatoid Arthritis Therapy: An Prospective Observational Study of the Intestinal Microbiome in Patients With Rheumatoid Arthritis Receiving Immunosuppressive Therapy
Date of first enrolment:	August 1, 2016
Target sample size:	50
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03775824
Study type:	Observational
Study design:
Phase:

Countries of recruitment

Contacts

Name:	Kristofer Andréasson, MD PhD
Address:
Telephone:
Email:
Affiliation:	Skane University Hospital

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: MTX start

Drug: TNF start

Primary Outcome(s)

Change in gut flora [Time Frame: Change from baseline Dysbiosis Index Score at 6 months]

Intestinal gut flora in rheumatoid arthritis [Time Frame: Analysis made at study start/baseline]

Change in disease activity/treatment response at follow up [Time Frame: Change from baseline DAS-28 at 6 months]

Secondary Outcome(s)

Adherance to immunosuppressive therapy [Time Frame: Analysis made at 6 months follow up]

Change in intestinal concentration Lactobacillus [Time Frame: Change from baseline concentration at 6 months]

Change in intestinal concentration Prevotella [Time Frame: Change from baseline concentration at 6 months]

Change in intestinal concentration Clostridia [Time Frame: Change from baseline concentration at 6 months]

Secondary ID(s)

FART1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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