NCT05973370

Evaluating the Effect of Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the potential therapeutic effects of the secondary bile acid ursodeoxycholic acid (UDCA) on synovial inflammation and disease activity when administered as add-on treatments to the current DMARDs treatment for rheumatoid arthritis patients with variant disease activity.

Detailed description

This study is a randomized, open-labeled, controlled prospective study to evaluate the potential therapeutic effects of the secondary bile acid ursodeoxycholic acid (UDCA) on synovial inflammation and disease activity when administered as add-on treatments to the current DMARDs treatments for rheumatoid arthritis patients with variant disease activity. The study population will be rheumatoid arthritis patients attending the Physical Medicine, Rheumatology, and Rehabilitation Department at Menoufia University Hospital in Menoufia, Egypt. A total of 60 rheumatoid arthritis patients who met the inclusion criteria will be enrolled in this study. The 60 participants will be divided into 30 rheumatoid arthritis patients who will receive placebo + the current DMARDs treatments of rheumatoid arthritis for 24 weeks and serve as the control group, and 30 rheumatoid arthritis patients who will receive DMARDs + ursodeoxycholic acid (UDCA) 500 mg/day for 24 weeks. Clinical examinations and laboratory parameters will be performed and measured at the beginning of the study, 12 weeks and 24 weeks after randomization to evaluate the efficacy of UDCA in the treatment of rheumatoid arthritis.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo will be administered to the control group for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
DRUG	Ursodeoxycholic acid (UDCA) 500 mg	All subjects will receive Ursodeoxycholic acid (UDCA) administered at 500 mg/day for 24 weeks as an addon treatment to the current DMARDs treatments for rheumatoid arthritis.

Timeline

• Start date: 2023-05-01
• Primary completion: 2023-11-30
• Completion: 2024-05-30
• First posted: 2023-08-02
• Last updated: 2024-06-03

Locations

1 site across 1 country: Egypt