Rheumatoid Arthritis
Conditions
Brief 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
Interventions
DRUGFexofenadine
tablet
DRUGPlacebo
tablet
Sponsors
October 6 University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ACR 20% | at baseline | improvement criteria (ACR20) response rate based on the count of tender/swollen joints, |
| (HAQDI) | 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 |
| CRP | at baseline | the level of CRP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TNF-α | at baseline and at week 12 | Serum level Tumor necrosis factor- alpha (TNF-α) |
| IL6 | at baseline and at week 12 | Serum level of IL6 |
Countries
Egypt
Contacts
Primary ContactAhmed Ismaeel
Backup ContactEngy Wahsh
Outcome results
None listed