Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT06108518
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06108518
Study Brief:
Protocol Section:
NCT06108518