Fexofenadine in Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Fexofenadine as Adjunct to Standard Rheumatoid Therapy in Patients With Active Rheumatoid

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05264025
• Other study ID #: FMBSUREC/08052022/Ismaeel
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 1, 2022
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: October 6 University
• Contact: Ahmed Ismaeel
• Phone: 01090905827
• Email: hoda_cp[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rheumatoid arthritis (RA) is an inflammatory autoimmune polyarthritis affecting ∼1% of the world population, resulting in the loss of joint function and progressive structural damage in affected joints. Fexofenadine has been widely used to treat various allergic diseases, like allergic rhinitis, conjunctivitis and chronic idiopathic urticaria. the molecular mechanisms underlying fexofenadine mediated inhibition of TNF-α signalling

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria

• Moderate to severe RA (disease activity score-28 joints: DAS-28 > 3.2) were recruited.

• Age between 18 - 60 years having active disease according to the diagnosis of an experienced rheumatologist, being under treatment with disease-modifying anti-rheumatic drugs (DMARDs), not receiving cytokine inhibitors

• Signing informed consent and willingness of the participant to accept randomization to any assigned treatment arm.

Exclusion Criteria:

• History of biological DMARDS.

• History/presence of acute heart disease, liver and kidney diseases, COPD

• Intolerance or allergy to fexofenadine or methotrexate

• Alcohol abuse

• Any changes in using medication (changing the dosage or type of medicines

• Receive hormone replacement therapy, warfarin, and other anticoagulants

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Fexofenadine
tablet
• Placebo
tablet

Locations

Country	Name	City	State
Egypt	Beni-Suef Hospital	Bani Suwayf
Egypt	Faculty of Medicine - Beni Suef Hospital	Bani Suwayf

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR 20%	improvement criteria (ACR20) response rate based on the count of tender/swollen joints,	at baseline
Primary	ACR 20%	improvement criteria (ACR20) response rate based on the count of tender/swollen joints,	at week 12
Primary	(HAQDI)	HAQ-DI (Health Assessment Score- Disability index), in which patients are asked to rate their capacity to perform 20 activities of daily living (ADL). Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section	at baseline
Primary	(HAQDI)	HAQ-DI (Health Assessment Score- Disability index), in which patients are asked to rate their capacity to perform 20 activities of daily living (ADL). Scoring within each section is from 0 (without any difficulty) to 3 (unable to do). For each section the score given to that section is the worst score within the section	at week 12
Primary	CRP	the level of CRP	at baseline
Primary	CRP	the level of CRP	at week 12
Secondary	TNF-a	Serum level Tumor necrosis factor- alpha (TNF-a)	at baseline and at week 12
Secondary	NF-?B	Serum level of NF-?B	at baseline and at week 12