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 | Recruiting Phase 4 DMC

• 1 other identifier: 01-TERC/NHRC-SZH/FB/939
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Rheumatoid Arthritis; Major Adverse Cardiac Events

Keywords

rheumatoid arthritis, Major adverse cardiac event, tofacitinib

Outcome Measures

Primary Outcomes (2)

• Major Adverse Cardiovascular Event

  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

  o The study aim to compare MACE in RA patients treated with tofacitinib and statin versus TNF inhibitors.

  6 months

Secondary Outcomes (2)

• effectiveness of tofacitinib in controlling disease activity

  6 months

• lipid profile

  6 months

Study Arms (2)

Tofacitinib and statins

EXPERIMENTAL

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

control group TNF inhibitor

ACTIVE COMPARATOR

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

Interventions

Tofacitinib 5 MG DRUG

* 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.

Also known as: statins

Tofacitinib and statins; control group TNF inhibitor

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shaikh Zayed Hospital, Lahore: lead

Study Sites (1)

Shaikh Zayed Hospital, Lahore

Lahore, Punjab Province, 45000, Pakistan

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Cardiovascular Diseases

Interventions

tofacitinib; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Masooma Hashmat, FCPS

  Shaikh Zayed Hospital, Lahore

  PRINCIPAL INVESTIGATOR

• Aflak Rasheed, FCPS

  Shaikh Zayed Hospital, Lahore

  STUDY DIRECTOR

• Maira Khalil, MBBS

  Shaikh Zayed Hospital, Lahore

  STUDY CHAIR

Central Study Contacts

Masooma Hashmat, FCPS Rheumatology

CONTACT

+923353053304; masoomahashmat@gmail.com

Aflak Rasheed, FCPS Rheumatology

CONTACT

+923009476913; aflakrasheed@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR.

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: December 6, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 MONTHS

Locations

PA (1)