Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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27 November 2023 |
Main ID: |
NCT05264025 |
Date of registration:
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10/01/2022 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Fexofenadine in Patients With Active Rheumatoid Arthritis
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Scientific title:
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Fexofenadine as Adjunct to Standard Rheumatoid Therapy in Patients With Active Rheumatoid |
Date of first enrolment:
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June 1, 2022 |
Target sample size:
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80 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/ct2/show/NCT05264025 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Ahmed Ismaeel |
Address:
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Telephone:
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01090905827 |
Email:
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hoda_cp@yahoo.com |
Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Fexofenadine
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Drug: Placebo
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Primary Outcome(s)
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ACR 20%
[Time Frame: at week 12]
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CRP
[Time Frame: at baseline]
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ACR 20%
[Time Frame: at baseline]
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CRP
[Time Frame: at week 12]
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(HAQDI)
[Time Frame: at week 12]
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(HAQDI)
[Time Frame: at baseline]
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Secondary Outcome(s)
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TNF-a
[Time Frame: at baseline and at week 12]
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NF-?B
[Time Frame: at baseline and at week 12]
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Secondary ID(s)
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FMBSUREC/08052022/Ismaeel
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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