Liver Fibrosis and Gut Microbiota in Patients With Psoriasis Vulgaris and Rheumatoid Arthritis on Methotrexate

Rheumatoid Arthritis Clinical Trial

Official title:

A Comparison Study of Liver Fibrosis and Its Association With Gut Microbiota in Patients With Psoriasis Vulgaris and Rheumatoid Arthritis on Methotrexate

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04493762
• Other study ID #: UW19-839
• Status: Not yet recruiting
• Start date: August 13, 2020
• Est. completion date: December 11, 2022

Study information

• Verified date: July 2020
• Source: The University of Hong Kong
• Contact: Sze-Man Wong, MSc, MRCP
• Phone: +852 22555154
• Email: wongsm11[@]ha.org.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

While methotrexate (MTX) remains a treatment of choice for patients with rheumatoid arthritis (RA), psoriasis (PsO) and psoriatic arthritis (PsA), long-term MTX use has been shown to be associated with liver fibrosis and cirrhosis in these patients. In addition, gut dysbiosis has been found to be associated with liver fibrosis and cirrhosis via the gut-liver axis, underscoring the potential role of gut microbiota and bacterial translocation in the pathogenesis of chronic liver diseases in these patients.

In this study, we aim to assess the prevalence of advanced liver fibrosis or cirrhosis among these patients on MTX treatment compared to those without, using transient elastography. We also aim to identify the possible risk factor(s) for advanced liver fibrosis or cirrhosis among them. Further, we aim to characterize the difference in fecal microbiota patterns among these three groups of patients.

Using a cross-sectional, prospective cohort design, this study will enroll approximately 600 eligible patients, including 300 patients with PsO/PsA and 300 patients with RA, to examine the following hypotheses:

1. Patients on higher cumulative dose of MTX will have higher prevalence of advanced liver fibrosis or cirrhosis compared to those on lower cumulative dose of MTX;

2. Patients with MTX use will have higher prevalence of advanced liver fibrosis or cirrhosis compared to those without MTX use;

3. The fecal microbiota composition will be different between patients with and without MTX treatment; and

4. The fecal microbiota composition will be different between patients with and without advanced fibrosis/cirrhosis while on MTX treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: December 11, 2022
• Est. primary completion date: December 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Age between 18 to 85 years

• Have regular follow up in Dermatology/ Rheumatology clinics of Queen Mary Hospital

• Diagnosed with PsO/PsA or RA

• Chinese ethnicity

Exclusion Criteria:

• Age below 18 years or above 85 years

• Known decompensated cirrhosis

• Pregnancy or breastfeeding

• Unstable medical illness or active infection

• Unable to provide written consent

• Unable to adhere to the protocol

• Unable to read and/or write Chinese language

• On anticoagulant/ antiplatelet treatment

• Abnormal platelet count <150

• Known disease/condition with prolonged INR/bleeding tendency

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Fibrosis
• Fibrosis, Liver
• Liver Cirrhosis
• Psoriasis
• Psoriasis Vulgaris
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients with advanced liver fibrosis or cirrhosis	We will measure the number of patients with significant fibrosis (defined as having liver stiffness = 7.5 kPa in transient elastography), and among those who undergo biopsy, the number of patients whose biopsy specimen is of Roenigk grades 3b or 4	At the time of the assessment procedure
Primary	The type and abundance of fecal microbiota patterns	We will measure the type and abundance of various bacteria/viruses in specimens; alpha diversity within a specimen and beta diversity between groups of specimen; specific taxa that differ significantly between groups; and metabolic profiles and functional pathways associated with change in gut microbiota	At the time of the assessment procedure
Secondary	The risk factors of liver fibrosis	Risk factors to be examined will include demographic variables such as age and gender, cumulative dose of MTX, gut dysbiosis, duration of disease, co-morbidities, hepatic steatosis, liver stiffness, and other potential factors	At the time of the assessment procedure