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Statins and ARBs on Rheumatoid Activity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 7, 2018
First Posted Date  ICMJE December 10, 2018
Last Update Posted Date December 10, 2018
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date December 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2018)
Change in disease activity score [ Time Frame: 6 months ]
DAS28-ESR
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Statins and ARBs on Rheumatoid Activity
Official Title  ICMJE Investigational and Comparative Study Between the Anti-inflammatory Effectof Both Angiotensin Reeptor Blockers and Statins on Rheumatoid Arthritis Disease Activity on Egyptian Patients
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Angiotensin receptor blockers
    Candesartan
    Other Name: Cansartan
  • Drug: Statins
    Atorvastatin
    Other Name: Ator
Study Arms  ICMJE
  • No Intervention: Control group
    No intervention
  • Active Comparator: Angiotensin receptor blockers
    ARB ( Angiotensin receptor blockers) + Traditional therpy.
    Intervention: Drug: Angiotensin receptor blockers
  • Active Comparator: Statins
    Statin + Traditional therapy.
    Intervention: Drug: Statins
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2018)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2026
Estimated Primary Completion Date December 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Rheumatoid arthritis.

Exclusion Criteria:

  • Pregnant or lactating
  • Hepatic or renal impairment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sherief Abd-Elsalam, Ph D 00201147773440 sheriefabdelsalam@yahoo.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03770702
Other Study ID Numbers  ICMJE Rheumatoid
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sherief Abd-Elsalam, Tanta University
Study Sponsor  ICMJE Sherief Abd-Elsalam
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Tanta University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP