Fexofenadine in Patients With Active Rheumatoid Arthritis

October 6 University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Fexofenadine

Study type: Interventional

Funder types: Other

Identifiers

NCT05264025

FMBSUREC/08052022/Ismaeel

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Fexo group

Active Comparator group

Treatment:

Drug: Fexofenadine

Placepo

Placebo Comparator group

Treatment:

Drug: Placebo