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

NCT06108518 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: Carvedilol in active RA
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Keywords

Carvedilol; Hypertension

Outcome Measures

Primary Outcomes (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.

  12 week

Secondary Outcomes (1)

• change in the serum level of the assessed biological markers

  12 week

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Drug: Carvedilol

Treatment group

ACTIVE COMPARATOR

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.

Drug: Carvedilol

Interventions

Carvedilol 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.

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid; Hypertension

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Dr/Tarek Mohamed, Professor

  Tanta University

  STUDY DIRECTOR

Central Study Contacts

Yomna Abdelrafea, Bachelor

CONTACT

01021683076; umna.a.rafea@gmail.com

Dr/Eman Ibrahim, Lecturer

CONTACT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: randomized, double blind placebo controlled parallel study

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: June 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04