Statins and ARBs on Rheumatoid Activity

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

Tracking Information

• First Submitted Date: December 7, 2018
• First Posted Date: December 10, 2018
• Last Update Posted Date: December 10, 2018
• Actual Study Start Date: October 1, 2018
• Estimated Primary Completion Date: December 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 7, 2018)

Change in disease activity score [ Time Frame: 6 months ]

DAS28-ESR

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Rheumatoid Arthritis

Intervention

• Drug: Angiotensin receptor blockers
  Candesartan
  Other Name: Cansartan
• Drug: Statins
  Atorvastatin
  Other Name: Ator

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 7, 2018): 45
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2026
• Estimated Primary Completion Date: December 1, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Rheumatoid arthritis.

Exclusion Criteria:

• Pregnant or lactating
• Hepatic or renal impairment.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03770702
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Responsible Party: Sherief Abd-Elsalam, Tanta University
• Study Sponsor: Sherief Abd-Elsalam
• Collaborators: Not Provided

Investigators

• 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