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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2024-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study Evaluating the Safety and Efficacy of Cura-100 in Subjects With Rheumatoid Arthritis and Osteoarthritis

NCT00455208

Rheumatoid Arthritis Osteoarthritis

UNKNOWN PHASE1/PHASE2

An Observational Study to Describe in Routine Clinical Practice the Treatment Patterns of Usage of Biological DMARDs in RA Patients.

NCT02590562

Rheumatoid Arthritis

COMPLETED

Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)

NCT01557322

Rheumatoid Arthritis

COMPLETED

An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy

NCT01664117

Rheumatoid Arthritis

COMPLETED

Treatment for Subjects With Active Rheumatoid Arthritis (RA)

NCT00110903

Rheumatoid Arthritis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, double blind placebo controlled parallel study

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Group1 (Placebo group; n=35) which will receive the standard treatment for RA plus placebo tablet for 3 months.

Group Type PLACEBO_COMPARATOR

Carvedilol

Intervention Type DRUG

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.

Treatment group

Group 2 (Carvedilol group; n=35) which will receive the standard treatment for RA plus 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.

Group Type ACTIVE_COMPARATOR

Carvedilol

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Carvedilol

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No