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NCT05973370CompletedPhase 2

Evaluating the Effect of Ursodeoxycholic Acid in Patients With Rheumatoid Arthritis

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

Source: ClinicalTrials.gov · Last updated 3 Jun 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
60 (actual)
First submitted
23 Jul 2023
Start date
1 May 2023
Primary completion date
30 Nov 2023
Lead sponsor
Tanta University
NCT number
NCT05973370

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 60
  • From 1 May 2023 to the primary completion date, 30 Nov 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients treated with biological therapy such as TNF-α or IL-1β antagonists.
  • Patients who have received an organ transplant.

Other illness

  • 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 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 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 clinically significant hepatic and renal dysfunction or impairment.
  • 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)

Other

  • Pregnant or planning to be pregnant and breast-feeding women
  • Patients who have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis).
  • Patients with electrolyte disturbances (such as hypokalemia, hypomagnesemia, and hypercalcemia) could potentially elevate the risk of digoxin toxicity.
  • Alcohol abuse
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Menoufia University Hospital
Coordinator of this site? Confirm its status
Shibīn al KawmEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.