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 (TOFSTAT)

April 21, 2026 updated by: Masooma Hashmat, Shaikh Zayed Hospital, Lahore

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective non randomized Clinical Trial Phase-4 aimed at observing the incidence of MACE in RA patients who have moderate to severe disease activity (as determined by the DAS-28 score) and one or more cardiovascular disease (CVD) risks. The patients included in the study will have non-responsiveness to standard cDMARDs treatment and will be prescribed tofacitinib 5 mg twice daily along with statins 20 mg daily as risk modification versus TNF Inhibitor as standard treatment will be the control group.

METHODOLOGY

  • Initial Assessment:

    • Baseline evaluation including DAS-28 score, lipid profile, and assessment of CVD risk factors (hypertension, diabetes, smoking, cholesterol levels, etc.).
    • Recruitment of patients based on inclusion and exclusion criteria.

  • Intervention:

    • 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: Lipid profile Total cholesterol, LDL, HDL, triglycerides, DAS-28 score, Recording of any CVD events (MACE), Monitoring of any other related complications.

  • Tofacitinib Discontinuation:

    o If a patient experiences a CVD event, tofacitinib will be stopped and documented.

  • Follow up:

    • Monthly visits for a 6 month, during which patient progress and any adverse events will be recorded.
    • If a MACE occurs, treatment with tofacitinib will be discontinued, and the event will be thoroughly documented.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 45000
        • Recruiting
        • Shaikh Zayed Hospital, Lahore
        • Contact:
        • Contact:
        • Principal Investigator:
          • Masooma Hashmat, FCPS
        • Principal Investigator:
          • Aflak Rasheed, FCPS
        • Sub-Investigator:
          • Maira Khalil, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • • RA diagnosis with moderate to severe disease activity, based on DAS-28 despite on > 2 conventional DMARDs.

    • One or more CVD risk factors, such as hypertension, diabetes, smoking, high cholesterol, etc.
    • Age 50 or older.

Exclusion Criteria:

  • Known contraindications to statins.

    • History of major adverse CV events (e.g., recent myocardial infarction or stroke).
    • Pregnancy or breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tofacitinib and statins
In one group tofacitinib (5 mg twice daily) and statins (atorvastatin 20 mg daily) will be added to the treatment regimen of the patients.
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.
Other Names:
  • statins
Active Comparator: control group TNF inhibitor
o In control group TNF inhibitor will be added to the treatment regimen of the patients as part of standard treatment
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.
Other Names:
  • statins

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular Event
Time Frame: 6 months
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.
6 months
Compare Incidence of MACE in two group
Time Frame: 6 months
o The study aim to compare MACE in RA patients treated with tofacitinib and statin versus TNF inhibitors.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effectiveness of tofacitinib in controlling disease activity
Time Frame: 6 months
o To evaluate the effectiveness of tofacitinib in reducing RA disease activity as measured by the DAS-28 score.
6 months
lipid profile
Time Frame: 6 months
o To assess the impact of statins on lipid profile in RA patients on tofacitinib
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaikh Zayed Hospital, Lahore

Investigators

  • Principal Investigator: Masooma Hashmat, FCPS, Shaikh Zayed Hospital, Lahore
  • Study Director: Aflak Rasheed, FCPS, Shaikh Zayed Hospital, Lahore
  • Study Chair: Maira Khalil, MBBS, Shaikh Zayed Hospital, Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-TERC/NHRC-SZH/FB/939

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

9 MONTHS

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Tofacitinib 5 MG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe