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Fexofenadine in Patients With Active Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Fexofenadine
Placebo
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Beni-Suef HospitalRecruiting
  • Faculty of Medicine - Beni Suef HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Fexo group

Placepo

Arm Description

Outcomes

Primary Outcome Measures

ACR 20%
improvement criteria (ACR20) response rate based on the count of tender/swollen joints,
ACR 20%
improvement criteria (ACR20) response rate based on the count of tender/swollen joints,
(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
(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
CRP
the level of CRP
CRP
the level of CRP

Secondary Outcome Measures

TNF-α
Serum level Tumor necrosis factor- alpha (TNF-α)
NF-κB
Serum level of NF-κB

Full Information

First Posted
January 10, 2022
Last Updated
March 22, 2023
Sponsor
October 6 University
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1. Study Identification

Unique Protocol Identification Number
NCT05264025
Brief Title
Fexofenadine in Patients With Active Rheumatoid Arthritis
Official Title
Fexofenadine as Adjunct to Standard Rheumatoid Therapy in Patients With Active Rheumatoid
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fexo group
Arm Type
Active Comparator
Arm Title
Placepo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fexofenadine
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
tablet
Primary Outcome Measure Information:
Title
ACR 20%
Description
improvement criteria (ACR20) response rate based on the count of tender/swollen joints,
Time Frame
at baseline
Title
ACR 20%
Description
improvement criteria (ACR20) response rate based on the count of tender/swollen joints,
Time Frame
at week 12
Title
(HAQDI)
Description
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 baseline
Title
(HAQDI)
Description
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 12
Title
CRP
Description
the level of CRP
Time Frame
at baseline
Title
CRP
Description
the level of CRP
Time Frame
at week 12
Secondary Outcome Measure Information:
Title
TNF-α
Description
Serum level Tumor necrosis factor- alpha (TNF-α)
Time Frame
at baseline and at week 12
Title
NF-κB
Description
Serum level of NF-κB
Time Frame
at baseline and at week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Ismaeel
Phone
01090905827
Email
hoda_cp@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Engy Wahsh
Phone
01003095692
Email
engywahsh@o6u.edu.eg
Facility Information:
Facility Name
Beni-Suef Hospital
City
Banī Suwayf
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmed
Phone
01090905827
Facility Name
Faculty of Medicine - Beni Suef Hospital
City
Banī Suwayf
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed, phd
Phone
01090905827

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Fexofenadine in Patients With Active Rheumatoid Arthritis

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