Status:
NOT_YET_RECRUITING
Clinical Study Evaluating the Effect of Carvedilol in Patients With Active Rheumatoid Arthritis
Lead Sponsor:
Tanta University
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
Brief Summary
This study aims at investigating the possible efficacy and safety of carvedilol as an adjunctive therapy in patients with active rheumatoid arthritis and hypertension.
Detailed Description
heumatoid arthritis (RA) is a chronic systemic autoimmune disease that primarily affects the lining of the synovial joints and is associated with progressive disability, premature death, and socioecon...
Eligibility Criteria
Inclusion
- Patients with active rheumatoid arthritis (not in remission) according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria i.e 28 joints disease activity score (DAS-28) \>2.6.
- Patients with hypertension who are candidate to carvidolol.
- Age range between 18 and 60 years old.
- The studywillbecarriedoutbetween June 2023 and June 2025.
- Both sexes.
- Sex ratio, body mass index (BMI), age, disease activity, and disease duration matched patients.
- Patients receive matched doses of standard treatment including methotrexate, non-steroidal anti-inflammatory drugs, selective cyclooxygenase-2 inhibitors, acetaminophen, and low dose of oral corticosteroids (prednisolone \< 15 mg) will be allowed to be enrolled the trial.
- Intravenous, intra-articular or intramuscular corticosteroids; intra-articular hyaluronate sodium and biological DMARDs will not be permitted less than 4 weeks before the first dose of carvedilol.
Exclusion
- Patients with congestive heart failure, other heart disease (arrhythmia, ischemic heart disease including angina and myocardial infarction).
- Patients with other inflammatory diseases and active infection.
- Patients with glaucoma.
- Patients with asthma, COPD, other lung diseases.
- Patients with hepatic and biliary diseases.
- Patients with chronic renal failure or those on dialysis.
- Patients with peripheral intermittent claudication and peripheral circulatory disorders.
- Patients receiving oral pednisolone greater than 15 mg/day.
- Patients receiving biological DMARDs.
- Patients with hypersensitivity to carvedilol.
- Patients using antioxidants.
- Pregnant and lactating females.
- Patients receiving digitalis, anti-arrhythmic (amiodarone, propafenone) MAOI, cyclosporine, calcium channel blockers (verapamil, deltiazem), beta blockers, other antihypertensive medications hepatic microsomal enzymes inducers or inhibitors (phenytoin, rifampin, valoproate), oral hypoglycemic and insulin to avoid potential pharmacodynamics
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06108518
Start Date
June 1 2024
End Date
November 1 2024
Last Update
April 16 2024
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