RecruitingPhase 1Phase 2NCT05264025

Fexofenadine in Patients With Active Rheumatoid Arthritis

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


Sponsor

October 6 University

Enrollment

80 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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

Interventions

DRUGFexofenadine

tablet

DRUGPlacebo

tablet


Locations(2)

Beni-Suef Hospital

Banī Suwayf, Egypt

Faculty of Medicine - Beni Suef Hospital

Banī Suwayf, Egypt

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NCT05264025


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