Rheumatoid ArthritisPhase 3NCT03770702
Statins and ARBs on Rheumatoid Activity
A Phase 3 study testing Angiotensin receptor blockers and Statins in people with Rheumatoid Arthritis, run by Sherief Abd-Elsalam at 1 site in Egypt.
Trial summary
Investigational and comparative study between the anti-inflammatory effectof both angiotensin reeptor blockers and statins on rheumatoid arthritis disease activity on Egyptian patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Angiotensin receptor blockers and Statins
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 1 Dec 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rheumatoid arthritis.
Who cannot join
- Pregnant or lactating
- Hepatic or renal impairment.
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
Ahmed El-Abd, Msc
About this study
Official title: Investigational and Comparative Study Between the Anti-inflammatory Effectof Both Angiotensin Reeptor Blockers and Statins on Rheumatoid Arthritis Disease Activity on Egyptian Patients
Investigational and comparative study between the anti-inflammatory effectof both angiotensin reeptor blockers and statins on rheumatoid arthritis disease activity on Egyptian patients
Read the detailed description
The study aims at ivestigating and comparing the anti-inflammatory effectof both angiotensin reeptor blockers and statins on rheumatoid arthritis disease activity on Egyptian patients
- Conditions
- Rheumatoid Arthritis
- Being tested
- Angiotensin receptor blockers, Statins
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin receptor blockersDrug
Also called Cansartan
Candesartan
StatinsDrug
Also called Ator
Atorvastatin
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention |
| Angiotensin receptor blockers | Active comparator | ARB ( Angiotensin receptor blockers) + Traditional therpy. Receives: Drug: Angiotensin receptor blockers |
| Statins | Active comparator | Statin + Traditional therapy. Receives: Drug: Statins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disease activity score
DAS28-ESR
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 completion1 Dec 2025 (estimated)
- Study completion1 Dec 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 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, Prof of Clinical PharmacyEmad M Elshebini, MD, Study chair, Rheumatology Dept. - Menoufia UniversityAhmed HM El-Abd, Msc, Study chair, Clinical pharmacy Department-Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770702
- Sponsor's protocol ID
- Rheumatoid
- 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
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
- Investigational and Comparative Study Between the Anti-inflammatory Effectof Both Angiotensin Reeptor Blockers and Statins on Rheumatoid Arthritis Disease Activity on Egyptian Patients
- ClinicalTrials.gov ID
- NCT03770702
- Acronym / sponsor ID
- Rheumatoid
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Sherief Abd-ElsalamUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (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.
Investigational and comparative study between the anti-inflammatory effectof both angiotensin reeptor blockers and statins on rheumatoid arthritis disease activity on Egyptian patients
Detailed description
The study aims at ivestigating and comparing the anti-inflammatory effectof both angiotensin reeptor blockers and statins on rheumatoid arthritis disease activity on Egyptian patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention |
| Angiotensin receptor blockers | Active comparator | Drug: Angiotensin receptor blockersARB ( Angiotensin receptor blockers) + Traditional therpy. |
| Statins | Active comparator | Drug: StatinsStatin + Traditional therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rheumatoid arthritis.
Key exclusion criteria (2 listed)
- Pregnant or lactating
- Hepatic or renal impairment.
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 |
|---|---|---|
| Angiotensin receptor blockersAlso: CansartanCandesartan | Drug | Angiotensin receptor blockers |
| StatinsAlso: AtorAtorvastatin | Drug | Statins |
Primary outcome
Change in disease activity score
Time frame: 6 months
DAS28-ESR
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.
- 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
Prof of Clinical Pharmacy
Emad M Elshebini, MD study chair
Rheumatology Dept. - Menoufia 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 Angiotensin receptor blockers and Statins 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 2 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?
Change in disease activity score (time frame: 6 months). 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 10 Dec 2018.