Fexofenadine in Patients With Active Rheumatoid Arthritis

• Sponsor: October 6 University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05264025
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 10.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Fexofenadine; Drug: Placebo	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Fexofenadine as Adjunct to Standard Rheumatoid Therapy in Patients With Active Rheumatoid
• Anticipated Study Start Date: Apr 1, 2022
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fexo group	Drug: Fexofenadine; tablet
Placebo Comparator: Placepo	Drug: Placebo; tablet

Outcome Measures

Primary Outcome Measures

1. ACR 20% [at baseline]

   improvement criteria (ACR20) response rate based on the count of tender/swollen joints,

2. ACR 20% [at week 12]

   improvement criteria (ACR20) response rate based on the count of tender/swollen joints,

3. (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

4. (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

5. CRP [at baseline]

   the level of CRP

6. CRP [at week 12]

   the level of CRP

Secondary Outcome Measures

1. TNF-α [at baseline and at week 12]

   Serum level Tumor necrosis factor- alpha (TNF-α)

2. NF-κB [at baseline and at week 12]

   Serum level of NF-κB

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• October 6 University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: engy wahsh, lecturer of clinical pharmacy, October 6 University
• ClinicalTrials.gov Identifier: NCT05264025
• Other Study ID Numbers: PR-PH-22
• First Posted: Mar 3, 2022
• Last Update Posted: Mar 3, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Fexofenadine

Study Results

No Results Posted as of Mar 3, 2022