NCT03770702

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at below P25 for phase_3 rheumatoid-arthritis

Timeline
6mo left

Started Oct 2018

Longer than P75 for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Oct 2018Dec 2026

Study Start

First participant enrolled

October 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2018

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

December 10, 2018

Status Verified

December 1, 2018

Enrollment Period

7.2 years

First QC Date

December 7, 2018

Last Update Submit

December 7, 2018

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Change in disease activity score

    DAS28-ESR

    6 months

Study Arms (3)

Control group

NO INTERVENTION

No intervention

Angiotensin receptor blockers

ACTIVE COMPARATOR

ARB ( Angiotensin receptor blockers) + Traditional therpy.

Drug: Angiotensin receptor blockers

Statins

ACTIVE COMPARATOR

Statin + Traditional therapy.

Drug: Statins

Interventions

Angiotensin receptor blockersDRUG

Candesartan

Also known as: Cansartan
Angiotensin receptor blockers
StatinsDRUG

Atorvastatin

Also known as: Ator
Statins

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid arthritis.

You may not qualify if:

  • Pregnant or lactating
  • Hepatic or renal impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, 35111, Egypt

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Angiotensin Receptor AntagonistsHydroxymethylglutaryl-CoA Reductase InhibitorsORANGE protein, Arabidopsis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAnticholesteremic AgentsHypolipidemic AgentsAntimetabolitesEnzyme InhibitorsLipid Regulating AgentsTherapeutic Uses

Study Officials

  • Sahar K Hegazy, Prof

    Head of Clinical Pharmacy Department

    PRINCIPAL INVESTIGATOR

  • Tarek M Mostafa, Prof

    Prof of Clinical Pharmacy

    STUDY DIRECTOR

  • Emad M Elshebini, MD

    Rheumatology Dept. - Menoufia University

    STUDY CHAIR

  • Ahmed HM El-Abd, Msc

    Clinical pharmacy Department-Tanta University

    STUDY CHAIR

Central Study Contacts

Sherief Abd-Elsalam, Ph D

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

December 7, 2018

First Posted

December 10, 2018

Study Start

October 1, 2018

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

December 10, 2018

Record last verified: 2018-12

Locations

EG(1)