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

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

Status
Not yet recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06108518
Enrollment
70
Registered
2023-10-31
Start date
2024-06-01
Completion date
2024-11-30
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Carvedilol, Hypertension

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 socioeconomic burdens. It is characterized with chronic production of pro-inflammatory cytokines, which lead to cartilage and bone degradation that results in tissue destruction by the patients' immune system (Guo et al., 2018). The high systemic inflammatory burden associated with RA appears to be a key driver of increased CV risk. This inflammatory state is linked to endothelial dysfunction and accelerated atherosclerosis (Giollo et al., 2018). Consequently, RA increases the risk of cardiovascular (CV) mortality by up to 50% compared with the general population and CV disease is the leading cause of death in RA patients. This leads to suggestion that reducing inflammation lowers CV risk in RA (Dijkshoorn et al., 2022). Therapies targeting inflammation remain the mainstay of RA treatment such as non- steroidal anti-inflammatory drugs (NSAIDs), non-biologic and biologic disease-modifying anti-rheumatic drugs (DMARDs), immune-osuppressants, and corticosteroids. However, current treatment strategies have many adverse effects and a significant proportion of RA patients did not effectively respond to them (Aletaha and Smolen., 2018). Consequently, it is crucial to find new therapeutic approaches for the management of inflammation as well as the prevention of cardiovascular complications in rheumatoid arthritis patients. Carvedilol is a non-selective β-blocker with α-adrenergic receptor antagonism properties which has been safely used in treatment of several cardiovascular disorders (Prajapati et al., 2017). Previous animal studies highlights evidences for the promising anti- arthritic effects of carvedilol that could be mediated through attenuation of leukocyte migration, alleviation of oxidative stress and suppression of pro-inflammatory cytokines such as tumor necrosis factor-α (TNF-α) and interlukin-6 (IL-6) and eicosanoids including prostaglandin E2 (PGE2) and leukotriene B4 (LTB4) (Arab and El-Sawalhi, 2013; Ahmed et al., 2017; Osman et al., 2017). Taken together, carvedilol has powerful antioxidant/anti-inflammatory properties; we aimed to investigate its protective potential against arthritis that may add further benefits for its clinical usefulness especially in RA patients with concomitant cardiovascular disorders

Interventions

DRUGCarvedilol

Treatment group will take carvedilol 12.5mg once a day for 2 days; this is increased to 25 mg once a day or 12.5 mg twice a day for 3 months.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Masking description

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

Intervention model description

randomized, double blind placebo controlled parallel study

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in DAS-28-CRP score and the Multidimensional Health Assessment Questionnaire (MDHAQ) scores.12 weekBy the end of the study we should notice decrease in DAS-28-CRP score and the Multidimensional Health Assessment Questionnaire (MDHAQ) scores.

Secondary

MeasureTime frameDescription
change in the serum level of the assessed biological markers12 weekBy the end of the study we should notice decrease in serum level of the assessed biological markers * C-reactive protein (CRP). * 8-hydroxydeoxyguanosine (8-OHdG). * Interlukin-6 (IL-6). * Leukotriene B4 (LTB4

Contacts

Primary ContactYomna Abdelrafea, Bachelor
umna.a.rafea@gmail.com01021683076
Backup ContactDr/Eman Ibrahim, Lecturer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026