Fexofenadine in Patients With Active Rheumatoid Arthritis

Study Overview
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Brief Summary
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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

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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Fexofenadine
* Drug: Placebo


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fexo group<br> | Drug: Fexofenadine<br>* tablet<br>|
| Placebo Comparator: Placepo<br> | Drug: Placebo<br>* tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACR 20% | improvement criteria (ACR20) response rate based on the count of tender/swollen joints, | at baseline | 
| ACR 20% | improvement criteria (ACR20) response rate based on the count of tender/swollen joints, | at week 12 | 
| (HAQDI) | 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 | at baseline | 
| (HAQDI) | 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 | at week 12 | 
| CRP | the level of CRP | at baseline | 
| CRP | the level of CRP | at week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNF-α | Serum level Tumor necrosis factor- alpha (TNF-α) | at baseline and at week 12 | 
| NF-κB | Serum level of NF-κB | at baseline and at week 12 |