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NCT04493762
Liver Fibrosis and Gut Microbiota in Patients With Psoriasis Vulgaris and Rheumatoid Arthritis on Methotrexate
trial in Psoriasis Vulgaris in 600 participants. Status unknown.
12 December 2021
Quick facts
| Lead sponsor | The University of Hong Kong |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 600 |
| Start date | 13 August 2020 |
| Primary completion | 12 December 2021 |
| Estimated completion | 11 December 2022 |
Conditions studied
- Psoriasis Vulgaris — all drugs for Psoriasis Vulgaris →
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
- Fibrosis, Liver — all drugs for Fibrosis, Liver →
Sponsor
The University of Hong Kong
Who can join
Adults 18 to 85, any sex, with Psoriasis Vulgaris or Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04493762
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04493762 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The University of Hong Kong
- Last refreshed: 30 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04493762.
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