Psoriasis VulgarisNCT04493762
Liver Fibrosis and Gut Microbiota in Patients With Psoriasis Vulgaris and Rheumatoid Arthritis on Methotrexate
An observational study of Psoriasis Vulgaris and Rheumatoid Arthritis, run by The University of Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Psoriasis Vulgaris, Rheumatoid Arthritis, Fibrosis, Liver
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 13 Aug 2020to 11 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who have regular follow up in Dermatology/ Rheumatology clinics of Queen Mary Hospital, with a diagnosis of PsO/PsA and/or RA will be identified and screened for eligibility.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Unable to read and/or write Chinese language
- On anticoagulant/ antiplatelet treatment
- Abnormal platelet count <150
- Known disease/condition with prolonged INR/bleeding tendency
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Comparison Study of Liver Fibrosis and Its Association With Gut Microbiota in Patients With Psoriasis Vulgaris and Rheumatoid Arthritis on Methotrexate
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.
Read more
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:
- 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;
- Patients with MTX use will have higher prevalence of advanced liver fibrosis or cirrhosis compared to those without MTX use;
- The fecal microbiota composition will be different between patients with and without MTX treatment; and
- The fecal microbiota composition will be different between patients with and without advanced fibrosis/cirrhosis while on MTX treatment.
- Conditions
- Psoriasis Vulgaris, Rheumatoid Arthritis, Fibrosis, Liver
- Keywords
- Methotrexate, Microbiota
- Medical subject headings
- Arthritis, Rheumatoid, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PSO/PSA | Patients diagnosed with psoriasis or psoriatic arthritis | |
| RA | Patients diagnosed with rheumatoid arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the time of the assessment procedure
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
Measured: At the time of the assessment procedure
Secondary outcomes (1)
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
Measured: At the time of the assessment procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start13 Aug 2020 (estimated)
- Primary completion12 Dec 2021 (estimated)
- Study completion11 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sze-Man Wong, Queen Mary Hospital, Hong Kong
- Investigators
- Sze-Man Wong, MSc, MRCP, Principal investigator, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493762
- Sponsor's protocol ID
- UW19-839
- Status last verified
- Jul 2020
- First submitted
- 15 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Study of Liver Fibrosis and Its Association With Gut Microbiota in Patients With Psoriasis Vulgaris and Rheumatoid Arthritis on Methotrexate
- ClinicalTrials.gov ID
- NCT04493762
- Acronym / sponsor ID
- UW19-839
- Conditions
- Psoriasis Vulgaris, Rheumatoid Arthritis, Fibrosis, Liver
- Keywords
- Methotrexate, Microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 13 Aug 2020 (estimated)
- Primary completion
- 12 Dec 2021 (estimated)
- Study completion
- 11 Dec 2022 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- Patients with MTX use will have higher prevalence of advanced liver fibrosis or cirrhosis compared to those without MTX use;
- The fecal microbiota composition will be different between patients with and without MTX treatment; and
- The fecal microbiota composition will be different between patients with and without advanced fibrosis/cirrhosis while on MTX treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSO/PSA | – | –Patients diagnosed with psoriasis or psoriatic arthritis |
| RA | – | –Patients diagnosed with rheumatoid arthritis |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who have regular follow up in Dermatology/ Rheumatology clinics of Queen Mary Hospital, with a diagnosis of PsO/PsA and/or RA will be identified and screened for eligibility.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of patients with advanced liver fibrosis or cirrhosis
Time frame: At the time of the assessment procedure
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
The type and abundance of fecal microbiota patterns
Time frame: At the time of the assessment procedure
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
1 secondary outcome
The risk factors of liver fibrosis
Time frame: At the time of the assessment procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sze-Man Wong, MSc, MRCP principal investigator
Queen Mary Hospital, Hong Kong
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriasis Vulgaris and Rheumatoid Arthritis, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sze-Man Wong, MSc, MRCP (+852 22555154, wongsm11@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with advanced liver fibrosis or cirrhosis (time frame: At the time of the assessment procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.