AzTrials
AzTrials

Rheumatoid ArthritisEarly Phase 1NCT06108518

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

A Early Phase 1 study testing Carvedilol in people with Rheumatoid Arthritis, run by Tanta University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Carvedilol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
No sites listed yet
Study dates
1 Jun 2024to Nov 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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

Trial locations and contacts

No sites are listed yet.

Yomna Abdelrafea, Bachelor contact

01021683076

umna.a.rafea@gmail.com

Dr/Eman Ibrahim, Lecturer contact

About this study

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

Read the 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

Being tested
Carvedilol
Keywords
Carvedilol, Hypertension
Medical subject headings
Arthritis, Rheumatoid, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarvedilolDrug

    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.

Study groups in NCT06108518
Study groupRoleWhat they receive
Control groupPlacebo comparatorGroup1 (Placebo group; n=35) which will receive the standard treatment for RA plus placebo tablet for 3 months.
Receives: Drug: Carvedilol
Treatment groupActive comparatorGroup 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.
Receives: Drug: Carvedilol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in DAS-28-CRP score and the Multidimensional Health Assessment Questionnaire (MDHAQ) scores.

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

    Measured: 12 week

Secondary outcomes (1)

  1. change in the serum level of the assessed biological markers

    By 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

    Measured: 12 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2023
  2. Study start1 Jun 2024 (estimated)
  3. Primary completionOct 2024 (estimated)
  4. Study completionNov 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized, double blind placebo controlled parallel study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06108518
Sponsor's protocol ID
Carvedilol in active RA
Status last verified
Apr 2024
First submitted
25 Oct 2023
Last updated
16 Apr 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Ahmed YM, Messiha BA and Abo-Saif AA. Granisetron and carvedilol can protect experimental rats against adjuvant-induced arthritis. Immunopharmacol Immunotoxicol., 2017; 39(2):97-104. Aletaha D, and Smolen JS. Diagnosis and Management of Rheumatoid Arthritis: A Review. JAMA. 2018; 320 (13):1360-1372. Aletaha D, Neogi T, Silman AJ, et al. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62(9):2569-2581. Arab HH and El-Sawalhi MM. Carvedilol alleviates adjuvant-induced arthritis and subcutaneous air pouch edema: Modulation of oxidative stress and inflammatory mediators. Toxicol Appl Pharmacol., 2013;268(2):241-248. Dijkshoorn B, Raadsen R and Nurmohamed MT. Cardiovascular Disease Risk in Rheumatoid Arthritis Anno 2022. J Clin Med., 2022 ;11(10):2704. El Miedany Y, El Gaafary M, Youssef SS, et al. Validity of the Developed Arabic Multidimensional Health Assessment Questionnaire for use in standard clinical care of patients with rheumatic diseases. Int J Rheum Dis., 2008; 11:224-236. Giollo A, Bissell LA and Buch MH. Cardiovascular outcomes of patients with rheumatoid arthritis prescribed disease modifying anti-rheumatic drugs: A review. Expert Opin Drug Saf., 2018 ;17(7):697-708. Guo Q, Wang Y, Xu D, et al. Rheumatoid arthritis: Pathological mechanisms and modern pharmacologic therapies. Bone Res., 2018; 6:15.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Carvedilol in people with Rheumatoid Arthritis, run by Tanta University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yomna Abdelrafea, Bachelor (01021683076, umna.a.rafea@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in DAS-28-CRP score and the Multidimensional Health Assessment Questionnaire (MDHAQ) scores. (time frame: 12 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06108518, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in