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

Shaikh Zayed Hospital, Lahore

Status and phase: Enrolling; Phase 4

Conditions: Major Adverse Cardiac Events; Rheumatoid Arthritis

Treatments: Drug: Tofacitinib 5 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT07554820

01-TERC/NHRC-SZH/FB/939

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Tofacitinib and statins

Experimental group

Description:

In one group tofacitinib (5 mg twice daily) and statins (atorvastatin 20 mg daily) will be added to the treatment regimen of the patients.

Treatment:

Drug: Tofacitinib 5 MG

control group TNF inhibitor

Active Comparator group

Description:

o In control group TNF inhibitor will be added to the treatment regimen of the patients as part of standard treatment

Treatment:

Drug: Tofacitinib 5 MG