Rheumatoid ArthritisPhase 3NCT03770923
Effect of Some Drugs on Rheumatoid Arithritis Activity
A Phase 3 study testing Rupatadine and Montelukast in people with Rheumatoid Arthritis, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Effect of Some Drugs on Rheumatoid Arithritis Activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Rupatadine and Montelukast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to Oct 2027
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatoid arthritis
Who cannot join
- liver or renal disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Sherief Abd-Elsalam
Tanta, 35111
Fedaa Kotkata, Msc
About this study
Official title: Clinical Study Evaluating the Effect of Histamine 1 Receptor Antagonist and Leukotreine Receptor Antagonist on Patients With Rheumatoid Arithritis
Effect of Some Drugs on Rheumatoid Arithritis Activity.
Read the detailed description
The study aims at evaluating the effect of Some Drugs on Rheumatoid Arithritis Activity.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Rupatadine, Montelukast
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RupatadineDrug
Rupatadine 10 mg daily
MontelukastDrug
Montelukast 10 mg daily
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | No intervention |
| Rupatadine | Active comparator | Rupatadine 10 mg once daily. Receives: Drug: Rupatadine |
| Montelukast | Active comparator | Montelukast 10 mg daily Receives: Drug: Montelukast |
What is being measured
The primary outcome is the main question the study is designed to answer.
se level of IL-17
change in level of IL-17
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start1 Oct 2018
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sherief Abd-Elsalam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- Sahar k Hegazy, Prof, Principal investigator, Head of Clinical Pharmacy DepartmentTarek M Mostafa, Prof, Study director, Clinical pharmacy Department- Tanta UniversitySalwa E Abd El-Ghany, Prof, Study chair, Rheumatology Dept. - Tanta UniversityFedaa AK Kotkata, Msc, Study chair, Clinical pharmacy Department-Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770923
- Sponsor's protocol ID
- Rheumatoid Arithritis
- Status last verified
- Dec 2018
- First submitted
- 7 Dec 2018
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mostafa TM, Hegazy SK, El-Ghany SEA, Kotkata FAE. Comparative study evaluating antihistamine versus leukotriene receptor antagonist as adjuvant therapy for rheumatoid arthritis. Eur J Clin Pharmacol. 2021 Dec;77(12):1825-1834. doi: 10.1007/s00228-021-03181-2. Epub 2021 Jul 4.
PubMed 34218304
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Effect of Histamine 1 Receptor Antagonist and Leukotreine Receptor Antagonist on Patients With Rheumatoid Arithritis
- ClinicalTrials.gov ID
- NCT03770923
- Acronym / sponsor ID
- Rheumatoid Arithritis
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 10 Dec 2018 (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.
Effect of Some Drugs on Rheumatoid Arithritis Activity.
Detailed description
The study aims at evaluating the effect of Some Drugs on Rheumatoid Arithritis Activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –No intervention |
| Rupatadine | Active comparator | Drug: RupatadineRupatadine 10 mg once daily. |
| Montelukast | Active comparator | Drug: MontelukastMontelukast 10 mg daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rheumatoid arthritis
Key exclusion criteria (1 listed)
- liver or renal disease
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 |
|---|---|---|
| RupatadineRupatadine 10 mg daily | Drug | Rupatadine |
| MontelukastMontelukast 10 mg daily | Drug | Montelukast |
Primary outcome
se level of IL-17
Time frame: 6 months
change in level of IL-17
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 10 Dec 2018.
- Derived from this study: PubMed 34218304Mostafa TM, Hegazy SK, El-Ghany SEA, Kotkata FAE. Comparative study evaluating antihistamine versus leukotriene receptor antagonist as adjuvant therapy for rheumatoid arthritis. Eur J Clin Pharmacol. 2021 Dec;77(12):1825-1834. doi: 10.1007/s00228-021-03181-2. Epub 2021 Jul 4.
- Individual participant dataSharing planned: Undecided
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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.
Sahar k Hegazy, Prof principal investigator
Head of Clinical Pharmacy Department
Tarek M Mostafa, Prof study director
Clinical pharmacy Department- Tanta University
Salwa E Abd El-Ghany, Prof study chair
Rheumatology Dept. - Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rupatadine and Montelukast in people with Rheumatoid Arthritis, run by Sherief Abd-Elsalam at 1 site 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 1 inclusion and 1 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 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Sherief Abd-Elsalam, Ph D (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
se level of IL-17 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03770923, which also lists 1 linked publication.
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 10 Dec 2018.