Fexofenadine in Patients With Active Rheumatoid Arthritis

Phase 1

Recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Fexofenadine; Drug: Placebo

• Registration Number: NCT05264025
• Lead Sponsor: October 6 University

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-03-03
• Study Start: 2022-06-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14
• Primary Completion: 2024-04
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fexo group	Fexofenadine	-
Placepo	Placebo	-

Primary Outcome Measures

Name	Time	Method
ACR 20%	at week 12	improvement criteria (ACR20) response rate based on the count of tender/swollen joints,
CRP	at week 12	the level of CRP
(HAQDI)	at week 12	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

Secondary Outcome Measures

Name	Time	Method
TNF-α	at baseline and at week 12	Serum level Tumor necrosis factor- alpha (TNF-α)
NF-κB	at baseline and at week 12	Serum level of NF-κB

Trial Locations

Locations (2)

Beni-Suef Hospital; 🇪🇬 Banī Suwayf, Egypt

Faculty of Medicine - Beni Suef Hospital; 🇪🇬 Banī Suwayf, Egypt