Back to resultsStatins and ARBs on Rheumatoid Activity
Primary Purpose
Rheumatoid Arthritis
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Angiotensin receptor blockers
Statins
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Rheumatoid arthritis.
Exclusion Criteria:
- Pregnant or lactating
- Hepatic or renal impairment.
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Control group
Angiotensin receptor blockers
Statins
Arm Description
No intervention
ARB ( Angiotensin receptor blockers) + Traditional therpy.
Statin + Traditional therapy.
Outcomes
Primary Outcome Measures
Change in disease activity score
DAS28-ESR
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03770702
Brief Title
Statins and ARBs on Rheumatoid Activity
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Angiotensin receptor blockers
Arm Type
Active Comparator
Arm Description
ARB ( Angiotensin receptor blockers) + Traditional therpy.
Arm Title
Statins
Arm Type
Active Comparator
Arm Description
Statin + Traditional therapy.
Intervention Type
Drug
Intervention Name(s)
Angiotensin receptor blockers
Other Intervention Name(s)
Cansartan
Intervention Description
Candesartan
Intervention Type
Drug
Intervention Name(s)
Statins
Other Intervention Name(s)
Ator
Intervention Description
Atorvastatin
Primary Outcome Measure Information:
Title
Change in disease activity score
Description
DAS28-ESR
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Rheumatoid arthritis.
Exclusion Criteria:
Pregnant or lactating
Hepatic or renal impairment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, Ph D
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahar K Hegazy, Prof
Organizational Affiliation
Head of Clinical Pharmacy Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tarek M Mostafa, Prof
Organizational Affiliation
Prof of Clinical Pharmacy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Emad M Elshebini, MD
Organizational Affiliation
Rheumatology Dept. - Menoufia University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed HM El-Abd, Msc
Organizational Affiliation
Clinical pharmacy Department-Tanta University
Official's Role
Study Chair
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
ZIP/Postal Code
35111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed El-Abd, Msc
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Statins and ARBs on Rheumatoid Activity
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