NCT05264025

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Jun 2022

Longer than P75 for phase_1 rheumatoid-arthritis

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

3.5 years

First QC Date

January 10, 2022

Last Update Submit

July 28, 2025

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (6)

  • ACR 20%

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

    at baseline

  • ACR 20%

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

    at week 12

  • (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

    at baseline

  • (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

    at week 12

  • CRP

    the level of CRP

    at baseline

  • CRP

    the level of CRP

    at week 12

Secondary Outcomes (2)

  • TNF-α

    at baseline and at week 12

  • IL6

    at baseline and at week 12

Study Arms (2)

Fexo group

ACTIVE COMPARATOR
Drug: Fexofenadine

Placepo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

FexofenadineDRUG

tablet

Fexo group
PlaceboDRUG

tablet

Placepo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beni-Suef Hospital

Banī Suwayf, Egypt

RECRUITING

Faculty of Medicine - Beni Suef Hospital

Banī Suwayf, Egypt

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

fexofenadine

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Ahmed Ismaeel

CONTACT

01090905827hoda_cp@yahoo.com

Engy Wahsh

CONTACT

01003095692engywahsh@o6u.edu.eg

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of clinical pharmacy

Study Record Dates

First Submitted

January 10, 2022

First Posted

March 3, 2022

Study Start

June 1, 2022

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP

Locations

EG(2)