Completed

Evaluating the Effect of Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis in Egypt

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What is being tested

Placebo

+ Ursodeoxycholic acid (UDCA) 500 mg

Drug
Who is being recruted

Arthritis+6

+ Arthritis, Rheumatoid

+ Autoimmune Diseases

From 18 to 80 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: May 2023
See protocol details

Summary

Principal SponsorTanta University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2023

Actual date on which the first participant was enrolled.

This clinical trial is being conducted to see if a medicine called ursodeoxycholic acid (UDCA) can help reduce inflammation and disease activity in people with rheumatoid arthritis. Rheumatoid arthritis is a condition where the body's immune system attacks its own joints, leading to pain and swelling. The study focuses on patients in Egypt who are already receiving standard treatments for rheumatoid arthritis but still experience varying levels of disease activity. By adding UDCA to their treatment regimen, researchers hope to find an effective way to improve the lives of these patients by potentially reducing joint inflammation and improving overall disease management. In this study, 60 people with rheumatoid arthritis will participate. They will be divided into two groups; one group will receive their usual arthritis medications along with a placebo, while the other group will receive their usual medications plus UDCA at a dose of 500 mg per day. This treatment will continue for 24 weeks. Researchers will conduct medical exams and laboratory tests at the start, then again at 12 weeks and 24 weeks, to assess how well UDCA is working. They will be looking at how UDCA affects inflammation and disease activity in the participants. The study is designed to track the safety and potential benefits of adding UDCA to standard rheumatoid arthritis treatments.

Official TitleEvaluating the Effect of Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis in Egypt
NCT05973370
Principal SponsorTanta University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisArthritis, RheumatoidAutoimmune DiseasesConnective Tissue DiseasesImmune System DiseasesJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSkin and Connective Tissue Diseases

Criteria

8 inclusion criteria required to participate
Diagnosed with rheumatoid arthritis according to the ACR/EULAR 2010 criteria.

Having active rheumatoid arthritis disease activity (the 28-joint disease activity score [DAS28] according to the CRP formula > 2.6).

Aged between 18 and 80 years.

With clear consciousness and able to cooperate with this study.

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19 exclusion criteria prevent from participating
Pregnant or planning to be pregnant and breast-feeding women

Patients suffering from any chronic diseases

Patients with other autoimmune diseases, such as systemic lupus erythematosus, Sjogren's syndrome and mixed connective tissue disease.

Patients who have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis).

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Participants in this arm will receive Placebo with the current DMARDs treatments for rheumatoid arthritis for 24 weeks.

Group II

Active Comparator
Participants in this arm will receive ursodeoxycholic acid (UDCA) 500 mg/day + DMARDs for 24 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Menoufia University Hospital

Shibīn al Kawm, EgyptOpen Menoufia University Hospital in Google Maps
CompletedOne Study Center