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Compares treatment options for Rheumatoid Arthritis
Official title 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
ClinicalTrials.gov ID: NCT07554820
What this study is testing
What is Tofacitinib 5 MG?
Tofacitinib 5 MG is an investigational medicine, given as an once-daily, being studied as a potential treatment for rheumatoid arthritis.
Also referred to as statins.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85
You may be able to join 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 likely can't join if
- Known contraindications to statins.
- History of major adverse CV events (e.g., recent myocardial infarction or stroke).
- Pregnancy or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Lahore, Punjab Province, Pakistan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lahore, Punjab Province, Pakistan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.