Rheumatoid ArthritisPhase 4TOFSTATNCT07554820
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
A Phase 4 study testing Tofacitinib 5 MG in people with Rheumatoid Arthritis and Major Adverse Cardiac Events, run by Shaikh Zayed Hospital, Lahore at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Rheumatoid Arthritis, Major Adverse Cardiac Events
- What is being tested?
- Tofacitinib 5 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Dec 2025to 30 Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- Known contraindications to statins.
- History of major adverse CV events (e.g., recent myocardial infarction or stroke).
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Shaikh Zayed Hospital, Lahore
Lahore, Punjab Province, 45000
Masooma Hashmat, FCPS, +923353053304, masoomahashmat@gmail.com
Aflak Rasheed, FCPS, +923009476913 ext. Hashmat, aflakrasheed@yahoo.com
About this study
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.
Read the 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:
- 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.
- Conditions
- Rheumatoid Arthritis, Major Adverse Cardiac Events
- Being tested
- Tofacitinib 5 MG
- Keywords
- rheumatoid arthritis, Major adverse cardiac event, tofacitinib
- Medical subject headings
- Arthritis, Rheumatoid, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib 5 MGDrug
Also called 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.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Tofacitinib 5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Compare Incidence of MACE in two group
- The study aim to compare MACE in RA patients treated with tofacitinib and statin versus TNF inhibitors.
Measured: 6 months
Secondary outcomes (2)
effectiveness of tofacitinib in controlling disease activity
- To evaluate the effectiveness of tofacitinib in reducing RA disease activity as measured by the DAS-28 score.
Measured: 6 months
lipid profile
- To assess the impact of statins on lipid profile in RA patients on tofacitinib
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start6 Dec 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaikh Zayed Hospital, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masooma Hashmat, Shaikh Zayed Hospital, Lahore
- Investigators
- Masooma Hashmat, FCPS, Principal investigator, Shaikh Zayed Hospital, LahoreAflak Rasheed, FCPS, Study director, Shaikh Zayed Hospital, LahoreMaira Khalil, MBBS, Study chair, Shaikh Zayed Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554820
- Sponsor's protocol ID
- 01-TERC/NHRC-SZH/FB/939
- Acronym
- TOFSTAT
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- TOFSTAT / 01-TERC/NHRC-SZH/FB/939
- Conditions
- Rheumatoid Arthritis, Major Adverse Cardiac Events
- Keywords
- rheumatoid arthritis, Major adverse cardiac event, tofacitinib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shaikh Zayed Hospital, LahoreUniversity, hospital or other
- Study start
- 6 Dec 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model 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.
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib and statins | Experimental | Drug: Tofacitinib 5 MGIn one group tofacitinib (5 mg twice daily) and statins (atorvastatin 20 mg daily) will be added to the treatment regimen of the patients. |
| control group TNF inhibitor | Active comparator | Drug: Tofacitinib 5 MGo In control group TNF inhibitor will be added to the treatment regimen of the patients as part of standard treatment |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • RA diagnosis with moderate to severe disease activity, based on DAS-28 despite on > 2 conventional DMARDs.
Key exclusion criteria (3 listed)
- Known contraindications to statins.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tofacitinib 5 MGAlso: 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. * 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. | Drug | Tofacitinib and statins, control group TNF inhibitor |
Primary outcome
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.
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.
2 secondary outcomes
effectiveness of tofacitinib in controlling disease activity
Time frame: 6 months
lipid profile
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Masooma Hashmat, FCPS principal investigator
Shaikh Zayed Hospital, Lahore
Aflak Rasheed, FCPS study director
Shaikh Zayed Hospital, Lahore
Maira Khalil, MBBS study chair
Shaikh Zayed Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tofacitinib 5 MG in people with Rheumatoid Arthritis and Major Adverse Cardiac Events, run by Shaikh Zayed Hospital, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Masooma Hashmat, FCPS Rheumatology (+923353053304, masoomahashmat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Event (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.