Clinical Study Evaluating the Effect of Carvedilol in Patients With Active Rheumatoid Arthritis

Carvedilol in active RA

This study aims at investigating the possible efficacy and safety of carvedilol as an adjunctive therapy in patients with active rheumatoid arthritis and hypertension.

2024-06-01

2024-10-01

2024-11-01

Not yet recruiting

Early phase I

70

Inclusion Criteria: * 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 Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized, double blind placebo controlled parallel study', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The blindness will be maintained by the similarity between the placebo and carvedilol tablets. The patients will be randomized by a neutral researcher using sealed envelope method with assigned code into two groups', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}

2024-04-16