MedTrace Logo

Major Adverse Cardiovascular Events (MACE) in Rheumatoid Arthritis Patient With Moderate to Severe Disease Activity Treated With Tofacitinib and Statins vs TNF Inhibitors: TOFSTAT CLINICAL TRIAL

NCT07554820 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-28

No results posted yet for this study

Summary

The rationale of our study is to observe the incidence of MACE in RA patients treated with tofacitinib along with statins with one or more cardiovascular disease risks.

PRIMARY OBJECTIVE

* To determine the incidence of MACE in Rheumatoid Arthritis patients with moderate to high disease activity and with one or more cardiovascular disease risks, which are non-responsive to standard conventional DMARDs (cDMARDs) treatment and are prescribed Tofacitinib 5 mg twice daily along with statin 20 mg daily versus TNF Inhibitors.
* The study aim to compare MACE in RA patients treated with tofacitinib and statin versus TNF inhibitors.

Conditions

Interventions

DRUG

Tofacitinib 5 MG

* In one group tofacitinib (5 mg twice daily) and statins (atorvastatin 20 mg daily) will be added to the treatment regimen of the patients. * In control group TNF inhibitor will be added to the treatment regimen of the patients as part of standard treatment. * Patients will be followed up monthly for a period of 6 months. * Monthly assessments during follow up will include Lipid profile Total cholesterol, LDL, HDL, triglycerides. DAS-28 score. Recording of any CVD events (MACE). Monitoring of any other related complications.

Sponsors & Collaborators

  • Shaikh Zayed Hospital, Lahore

    lead OTHER

Principal Investigators

  • Masooma Hashmat, FCPS · Shaikh Zayed Hospital, Lahore

  • Aflak Rasheed, FCPS · Shaikh Zayed Hospital, Lahore

  • Maira Khalil, MBBS · Shaikh Zayed Hospital, Lahore

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-06
Primary Completion
2026-08-31
Completion
2026-09-30

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07554820 on ClinicalTrials.gov