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

NCT05264025 Phase 1/Phase 2 RECRUITING

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

Details

Lead sponsor	October 6 University
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	80
Start date	2022-06-01
Completion	2026-01

Conditions

• Rheumatoid Arthritis

Interventions

• Fexofenadine
• Placebo

Primary outcomes

• ACR 20% — at baseline
  improvement criteria (ACR20) response rate based on the count of tender/swollen joints,
• ACR 20% — at week 12
  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
• (HAQDI) — at week 12
  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
• CRP — at week 12
  the level of CRP

Countries

Egypt