Faecal Analyses in Rheumatoid Arthritis Therapy

NCT03775824 | Completed

• 1 other identifier: FART1
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Keywords

microbiome; methotrexate; tnf-inhibitor; dysbiosis

Outcome Measures

Primary Outcomes (3)

• Intestinal gut flora in rheumatoid arthritis

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

  Analysis made at study start/baseline

• Change in gut flora

  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 from baseline Dysbiosis Index Score at 6 months

• Change in disease activity/treatment response at follow up

  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.

  Change from baseline DAS-28 at 6 months

Secondary Outcomes (4)

• Adherance to immunosuppressive therapy

  Analysis made at 6 months follow up

• Change in intestinal concentration Prevotella

  Change from baseline concentration at 6 months

• Change in intestinal concentration Lactobacillus

  Change from baseline concentration at 6 months

• Change in intestinal concentration Clostridia

  Change from baseline concentration at 6 months

Study Arms (2)

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.

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

Drug: TNF start

Interventions

MTX start DRUG

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

Also known as: MTX

MTX start

TNF start DRUG

Patient prescribed TNF-inhibitor because of active rheumatoid arthritis

Also known as: TNF

TNF start

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead

Related Publications (3)

• Andreasson K, Alrawi Z, Persson A, Jonsson G, Marsal J. Intestinal dysbiosis is common in systemic sclerosis and associated with gastrointestinal and extraintestinal features of disease. Arthritis Res Ther. 2016 Nov 29;18(1):278. doi: 10.1186/s13075-016-1182-z.

  PMID: 27894337 BACKGROUND

• Zhang X, Zhang D, Jia H, Feng Q, Wang D, Liang D, Wu X, Li J, Tang L, Li Y, Lan Z, Chen B, Li Y, Zhong H, Xie H, Jie Z, Chen W, Tang S, Xu X, Wang X, Cai X, Liu S, Xia Y, Li J, Qiao X, Al-Aama JY, Chen H, Wang L, Wu QJ, Zhang F, Zheng W, Li Y, Zhang M, Luo G, Xue W, Xiao L, Li J, Chen W, Xu X, Yin Y, Yang H, Wang J, Kristiansen K, Liu L, Li T, Huang Q, Li Y, Wang J. The oral and gut microbiomes are perturbed in rheumatoid arthritis and partly normalized after treatment. Nat Med. 2015 Aug;21(8):895-905. doi: 10.1038/nm.3914. Epub 2015 Jul 27.

  PMID: 26214836 BACKGROUND

• Pianta A, Arvikar SL, Strle K, Drouin EE, Wang Q, Costello CE, Steere AC. Two rheumatoid arthritis-specific autoantigens correlate microbial immunity with autoimmune responses in joints. J Clin Invest. 2017 Aug 1;127(8):2946-2956. doi: 10.1172/JCI93450. Epub 2017 Jun 26.

  PMID: 28650341 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Faecal and blood samples from study participants are stored in a biorepository.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Dysbiosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Kristofer Andréasson, MD PhD

  Skane University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 14, 2018
• Study Start: August 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: June 1, 2019
• Last Updated: September 16, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share