Evaluating the Effect of Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis in Egypt
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Changes from Baseline in DAS28-CRP activity Score
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Control
Participants in this arm will receive Placebo with the current DMARDs treatments for rheumatoid arthritis for 24 weeks.
Intervention: Placebo (Drug)
Ursodeoxycholic acid (UDCA)
Participants in this arm will receive ursodeoxycholic acid (UDCA) 500 mg/day + DMARDs for 24 weeks.
Intervention: Ursodeoxycholic acid (UDCA) 500 mg (Drug)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Numbers of participants with treatment-related adverse events(Baseline, after 12 weeks, after 24 weeks)
- Changes in ACR50 and ACR70 response criteria(Baseline, after 12 weeks, after 24 weeks)
- Changes in EULAR response criteria(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(Baseline, after 12 weeks, after 24 weeks)
Investigators
Mariam George Tadros Bolous
Assistant Lecturer of Clinical pharmacy, Faculty of Pharmacy, Sinai University
Tanta University