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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 27 November 2023
Main ID:  NCT05264025
Date of registration: 10/01/2022
Prospective Registration: Yes
Primary sponsor: October 6 University
Public title: Fexofenadine in Patients With Active Rheumatoid Arthritis
Scientific title: Fexofenadine as Adjunct to Standard Rheumatoid Therapy in Patients With Active Rheumatoid
Date of first enrolment: June 1, 2022
Target sample size: 80
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/ct2/show/NCT05264025
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).  
Phase:  Phase 1/Phase 2
Countries of recruitment
Egypt
Contacts
Name:     Ahmed Ismaeel
Address: 
Telephone: 01090905827
Email: hoda_cp@yahoo.com
Affiliation: 
Key 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Fexofenadine
Drug: Placebo
Primary Outcome(s)
ACR 20% [Time Frame: at week 12]
CRP [Time Frame: at baseline]
ACR 20% [Time Frame: at baseline]
CRP [Time Frame: at week 12]
(HAQDI) [Time Frame: at week 12]
(HAQDI) [Time Frame: at baseline]
Secondary Outcome(s)
TNF-a [Time Frame: at baseline and at week 12]
NF-?B [Time Frame: at baseline and at week 12]
Secondary ID(s)
FMBSUREC/08052022/Ismaeel
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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