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
Recruiting
Phase 4
Interventional Study
Rheumatoid Arthritis
Major Adverse Cardiac Events
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 50 – 85
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- Shaikh Zayed Hospital, Lahore · Other
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About This Trial
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 D…
Trial Locations
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Eligibility Criteria
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…
Contacts