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NCT Number: NCT05264025

Fexofenadine in Patients With Active Rheumatoid Arthritis

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beni-Suef Hospital, Banī Suwayf, Egypt

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fexofenadine

Drug

tablet

Placebo

Drug

tablet

Primary outcomes

  1. ACR 20%

    Time frame: at baseline

    improvement criteria (ACR20) response rate based on the count of tender/swollen joints,

  2. ACR 20%

    Time frame: at week 12

    improvement criteria (ACR20) response rate based on the count of tender/swollen joints,

  3. (HAQDI)

    Time frame: at baseline

    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

  4. (HAQDI)

    Time frame: 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

  5. CRP

    Time frame: at baseline

    the level of CRP

  6. CRP

    Time frame: at week 12

    the level of CRP

Secondary outcomes

  1. TNF-α

    Time frame: at baseline and at week 12

    Serum level Tumor necrosis factor- alpha (TNF-α)

  2. IL6

    Time frame: at baseline and at week 12

    Serum level of IL6

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Ismaeel

CONTACT

[email protected]

01090905827

Engy Wahsh

CONTACT

[email protected]

01003095692

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 3, 2022
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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