Fexofenadine in Patients With Active Rheumatoid Arthritis
ConditionRheumatoid Arthritis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorOctober 6 University
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
History of biological DMARDS.
History/presence of acute heart disease, liver and kidney diseases, COPD
Intolerance or allergy to fexofenadine or methotrexate
Alcohol abuse
Trial design
Design model
Parallel
Treatments tested in this trial
Fexofenadine
Drugtablet
Placebo
Drugtablet
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Fexo groupActive comparator 1 intervention
Group B: PlacepoPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
ACR 20%
improvement criteria (ACR20) response rate based on the count of tender/swollen joints,
Time frame
at baseline2
ACR 20%
improvement criteria (ACR20) response rate based on the count of tender/swollen joints,
Time frame
at week 123
(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
Time frame
at baseline4
(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
Time frame
at week 12Secondary outcomes
1
TNF-α
Serum level Tumor necrosis factor- alpha (TNF-α)
Time frame
at baseline and at week 122
IL6
Serum level of IL6
Time frame
at baseline and at week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov