Using fexofenadine to treat active rheumatoid arthritis
Official title: Fexofenadine as Adjunct to Standard Rheumatoid Therapy in Patients With Active Rheumatoid
Run by October 6 University · NCT05264025 · Data updated 2026-11-12
This study is testing if fexofenadine, a medication usually for allergies, can help people with active rheumatoid arthritis feel better by reducing inflammation.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | October 6 University Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 2 sites (Banī Suwayf and 1 other locations) |
| Status | Recruiting |
| Started | June 1, 2022 |
| Main results expected | December 2025 |
| Study ends | January 2026 |
| Registry record updated | July 31, 2025 |
| Trial ID | NCT05264025 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 60 with moderate to severe rheumatoid arthritis who are currently receiving DMARDs.
✕Probably not a fit
Patients with a history of biological DMARDs or those with certain comorbidities like heart disease or liver conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of fexofenadine, a medication commonly used for allergic conditions, on patients with active rheumatoid arthritis (RA). The study aims to assess the drug's ability to inhibit TNF-α signaling, which is involved in the inflammatory processes of RA. Participants will be randomly assigned to receive either fexofenadine or a placebo while being monitored for changes in disease activity. The trial includes individuals aged 18 to 60 with moderate to severe RA who are currently on disease-modifying anti-rheumatic drugs but not on cytokine inhibitors.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for managing inflammation in rheumatoid arthritis.
How similar studies have gone: While fexofenadine is primarily known for treating allergic conditions, its application in rheumatoid arthritis is novel and has not been extensively tested in similar studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Beni-Suef Hospital
Banī Suwayf, Egypt Recruiting -
Faculty of Medicine - Beni Suef Hospital
Banī Suwayf, Egypt Recruiting
Study contacts
- Study coordinator: Ahmed Ismaeel
- Email: hoda_cp@yahoo.com
- Phone: 01090905827
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.