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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Placebo will be administered to the control group for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
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.
Menoufia University Hospital
Shibīn al Kawm, Egypt
Changes in ACR20 response criteria
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.
Time frame: Baseline, after 12 weeks, after 24 weeks
Changes from Baseline in DAS28-CRP activity Score
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.
Time frame: Baseline, after 12 weeks, after 24 weeks
Changes in ACR50 and ACR70 response criteria
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.
Time frame: Baseline, after 12 weeks, after 24 weeks
Changes in EULAR response criteria
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.
Time frame: Baseline, after 12 weeks, after 24 weeks
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Changes from baseline Measurement of inflammatory markers (IL-17A, IL-23, HIF-1α, VEGF) at 12 and 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.
Time frame: Baseline, after 12 weeks, after 24 weeks
Numbers of participants with treatment-related adverse events
The adverse events in each group will be observed and documented during the whole procedure to show the safety of the treatment.
Time frame: Baseline, after 12 weeks, after 24 weeks