Evaluating the Effect of Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis

May 30, 2024 updated by: Mariam George Tadros Bolous, Tanta University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Shibīn Al Kawm, Egypt
        • Menoufia University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • Personal willingness and ability to comply with the study follow-up schedule and other requirements of the study protocol.
  • Both male and female will be included
  • All patients receiving non-biological drugs will be also included.
  • Sign an informed consent for the clinical study.

Exclusion Criteria:

  • 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).
  • Patients with a history of, or suspected, demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis).
  • Patients with a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease.
  • Patients treated with biological therapy such as TNF-α or IL-1β antagonists.
  • Patients with infectious or inflammatory diseases, endocrine disorders, any past or current psychiatric or neurological diseases.
  • Patients with cardiovascular diseases such as arrhythmias and acute myocardial infarction.
  • Patients with electrolyte disturbances (such as hypokalemia, hypomagnesemia, and hypercalcemia) could potentially elevate the risk of digoxin toxicity.
  • Patients with clinically significant hepatic and renal dysfunction or impairment.
  • Alcohol abuse
  • Patients with evidence of viral (HBV or HCV), autoimmune hepatitis, and decompensated liver disease.
  • Patients with cancer currently diagnosed or in medical history, if no recovery was achieved.
  • Patients who are allergic to Ursodeoxycholic acid (UDCA)
  • Patients who are unconscious and unable to complete the study.
  • Patients with acute inflammation of the gall bladder or the biliary tract, frequent episodes of biliary colic, and impaired contractility of the gall bladder, will be excluded.
  • Patients with cholestasis, primary biliary cirrhosis, or biliary obstruction will also be excluded.
  • Patients who have received an organ transplant.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Participants in this arm will receive Placebo with the current DMARDs treatments for rheumatoid arthritis for 24 weeks.
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.
Active Comparator: Ursodeoxycholic acid (UDCA)
Participants in this arm will receive ursodeoxycholic acid (UDCA) 500 mg/day + DMARDs for 24 weeks.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in ACR20 response criteria
Time Frame: Baseline, after 12 weeks, after 24 weeks
The American College of Rheumatology (ACR) response criteria (ACR20) for rheumatoid arthritis (RA) has been widely adopted as measures of medication efficacy in clinical trials. The ACR20 response has been the preferred endpoint for clinical trials because it is the response shown to discriminate optimally between active treatment and placebo while identifying a few placebo-treated patients as improved.
Baseline, after 12 weeks, after 24 weeks
Changes from Baseline in DAS28-CRP activity Score
Time Frame: Baseline, after 12 weeks, after 24 weeks
To evaluate the effect of the use of UDCA as an add-on therapy in patients with rheumatoid arthritis by evaluating the change from baseline in the clinical findings as measured by Clinical Disease activity score 28 (DAS28-CRP) scores. A lower DAS28-CRP score from Baseline would mean improvement in disease activity and an increase in DAS28-CRP score from Baseline would mean an increase in disease activity or a worsening in disease activity.
Baseline, after 12 weeks, after 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numbers of participants with treatment-related adverse events
Time Frame: Baseline, after 12 weeks, after 24 weeks
The adverse events in each group will be observed and documented during the whole procedure to show the safety of the treatment.
Baseline, after 12 weeks, after 24 weeks
Changes from baseline Measurement of inflammatory markers (IL-17A, IL-23, HIF-1α, VEGF) at 12 and 24 weeks
Time Frame: Baseline, after 12 weeks, after 24 weeks
Serum IL-17A, IL-23, VEGF and HIF-1α levels (pg/ml) will be measured by means of the human enzyme-linked immunosorbent assay (ELISA) technique according to the manufacturer's protocol.
Baseline, after 12 weeks, after 24 weeks
Changes in ACR50 and ACR70 response criteria
Time Frame: Baseline, after 12 weeks, after 24 weeks
The American College of Rheumatology (ACR) response criteria (ACR50 and 70) for rheumatoid arthritis (RA) have been widely adopted as measures of medication efficacy in clinical trials. The ACR50 and ACR70 responses have been the preferred endpoints for clinical trials because their responses have been shown to discriminate optimally between active treatment and placebo while identifying a few placebo-treated patients as improved.
Baseline, after 12 weeks, after 24 weeks
Changes in EULAR response criteria
Time Frame: Baseline, after 12 weeks, after 24 weeks
The European League Against Rheumatism (EULAR) response criteria for rheumatoid arthritis (RA) has been widely adopted as a measure of medication efficacy in clinical trials.
Baseline, after 12 weeks, after 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Study Chair: Nageh Ahmed El-Mahdy, Professor, Professor of Pharmacology and Toxicology Faculty of Pharmacy, Tanta University
  • Study Director: Enass Yousef Osman, PHD, Lecturer of Pharmacology and toxicology, Faculty of Pharmacy, Tanta University
  • Principal Investigator: Mariam George Tadros Bolous, Master, Assistant Lecturer of Clinical pharmacy, Faculty of Pharmacy, Sinai University
  • Study Chair: Medhat Ismail Abdel Hamid, Professor, Professor of Pharmacology and Toxicology Faculty of Medicine, Al-Azhar University
  • Study Director: Dalia Salah Seif, Associate Professor, Associate Professor of Physical Medicine, Rheumatology and Rehabilitation Faculty of Medicine, Menoufyia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

July 23, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 30, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Effect of UDCA on Rheumatoid

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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