Fexofenadine in Patients With Active Rheumatoid Arthritis

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

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

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Placebo; Drug: Fexofenadine

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Engy Wahsh; Phone Number: 01003095692; Email: engywahsh@o6u.edu.eg
• Study Contact Backup: Name: Ahmed Ismaeel; Phone Number: 01090905827; Email: hoda_cp@yahoo.com

Study Locations

• Egypt
  • Banī Suwayf, Egypt
    • Recruiting
    • Beni-Suef Hospital
    • Contact: ahmed; Phone Number: 01090905827
  • Banī Suwayf, Egypt
    • Recruiting
    • Faculty of Medicine - Beni Suef Hospital
    • Contact: Ahmed, phd; Phone Number: 01090905827

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fexo group	Drug: Fexofenadine; tablet
Placebo Comparator: Placepo	Drug: Placebo; tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACR 20%	improvement criteria (ACR20) response rate based on the count of tender/swollen joints,	at baseline
ACR 20%	improvement criteria (ACR20) response rate based on the count of tender/swollen joints,	at week 12
(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
(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
CRP	the level of CRP	at baseline
CRP	the level of CRP	at week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TNF-α	Serum level Tumor necrosis factor- alpha (TNF-α)	at baseline and at week 12
IL6	Serum level of IL6	at baseline and at week 12

Collaborators and Investigators

• Sponsor: October 6 University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: February 21, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine H1 Antagonists, Non-Sedating; Fexofenadine
• Other Study ID Numbers: FMBSUREC/08052022/Ismaeel

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No