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Statins and ARBs on Rheumatoid Activity

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ClinicalTrials.gov Identifier: NCT03770702
Recruitment Status : Recruiting
First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

Study Description
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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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Angiotensin receptor blockers Drug: Statins Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 1, 2025
Estimated Study Completion Date : December 1, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control group
No intervention
Active Comparator: Angiotensin receptor blockers
ARB ( Angiotensin receptor blockers) + Traditional therpy.
 Drug: Angiotensin receptor blockers
Candesartan
Other Name: Cansartan
Active Comparator: Statins
Statin + Traditional therapy.
 Drug: Statins
Atorvastatin
Other Name: Ator


Outcome Measures
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Primary Outcome Measures :
  1. Change in disease activity score [ Time Frame: 6 months ]
    DAS28-ESR


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rheumatoid arthritis.

Exclusion Criteria:

  • Pregnant or lactating
  • Hepatic or renal impairment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03770702


Contacts
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Contact: Sherief Abd-Elsalam, Ph D 00201147773440 sheriefabdelsalam@yahoo.com

Locations
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Egypt
Sherief Abd-Elsalam Recruiting
Tanta, Egypt, 35111
Contact: Ahmed El-Abd, Msc         
Sponsors and Collaborators
Sherief Abd-Elsalam
Investigators
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Principal Investigator: Sahar K Hegazy, Prof Head of Clinical Pharmacy Department
Study Director: Tarek M Mostafa, Prof Prof of Clinical Pharmacy
Study Chair: Emad M Elshebini, MD Rheumatology Dept. - Menoufia University
Study Chair: Ahmed HM El-Abd, Msc Clinical pharmacy Department-Tanta University
More Information
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Responsible Party: Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine, Tanta University
ClinicalTrials.gov Identifier: NCT03770702    
Other Study ID Numbers: Rheumatoid
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action