Rheumatoid ArthritisPhase 1/2NCT05264025
Fexofenadine in Patients With Active Rheumatoid Arthritis
A Phase 1/2 study testing Fexofenadine in people with Rheumatoid Arthritis, run by October 6 University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Fexofenadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jun 2022to Jan 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites, 2 recruiting
- Recruiting
Beni-Suef Hospital
Banī Suwayf
ahmed, 01090905827
- Recruiting
Faculty of Medicine - Beni Suef Hospital
Banī Suwayf
Ahmed, phd, 01090905827
About this study
Official title: Fexofenadine as Adjunct to Standard Rheumatoid Therapy in Patients With Active Rheumatoid
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
- Conditions
- Rheumatoid Arthritis
- Being tested
- Fexofenadine, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FexofenadineDrug
tablet
PlaceboDrug
tablet
| Study group | Role | What they receive |
|---|---|---|
| Fexo group | Active comparator | Not described Receives: Drug: Fexofenadine |
| Placepo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR 20%
improvement criteria (ACR20) response rate based on the count of tender/swollen joints,
Measured: at baseline
ACR 20%
improvement criteria (ACR20) response rate based on the count of tender/swollen joints,
Measured: 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
Measured: 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
Measured: at week 12
CRP
the level of CRP
Measured: at baseline
CRP
the level of CRP
Measured: at week 12
Secondary outcomes (2)
TNF-α
Serum level Tumor necrosis factor- alpha (TNF-α)
Measured: at baseline and at week 12
IL6
Serum level of IL6
Measured: at baseline and at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start1 Jun 2022
- Primary completionDec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, engy wahsh, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264025
- Sponsor's protocol ID
- FMBSUREC/08052022/Ismaeel
- Status last verified
- Jul 2025
- First submitted
- 10 Jan 2022
- Last updated
- 31 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fexofenadine as Adjunct to Standard Rheumatoid Therapy in Patients With Active Rheumatoid
- ClinicalTrials.gov ID
- NCT05264025
- Acronym / sponsor ID
- FMBSUREC/08052022/Ismaeel
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fexo group | Active comparator | Drug: Fexofenadine |
| Placepo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fexofenadinetablet | Drug | Fexo group |
| Placebotablet | Drug | Placepo |
Primary outcome
ACR 20%
Time frame: at baseline
improvement criteria (ACR20) response rate based on the count of tender/swollen joints,
ACR 20%
Time frame: at week 12
improvement criteria (ACR20) response rate based on the count of tender/swollen joints,
(HAQDI)
Time frame: 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)
Time frame: 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
Time frame: at baseline
the level of CRP
CRP
Time frame: at week 12
the level of CRP
2 secondary outcomes
TNF-α
Time frame: at baseline and at week 12
IL6
Time frame: at baseline and at week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fexofenadine in people with Rheumatoid Arthritis, run by October 6 University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Ismaeel (01090905827, hoda_cp@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACR 20% (time frame: at baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.