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Association of Leflunomide with Early-Stage Atherosclerotic Lesions in Rheumatoid Arthritis Patients

Association of Leflunomide with Early-Stage Atherosclerotic Lesions in Rheumatoid Arthritis Patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600124299
Enrollment
Unknown
Registered
2026-05-09
Start date
2026-05-16
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subclinical Atherosclerosis

Interventions

Exposed group (leflunomide)
Control group (without leflunomide):None

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 - 75 years old, gender unrestricted; 2. RA diagnosis: Confirmed as rheumatoid arthritis in accordance with the 2010 classification criteria of the American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR). 3. Disease activity: Patients with either active or stable disease are eligible, with a DAS28 score > 2.6 at the time of enrollment.

Exclusion criteria

Exclusion criteria: 1. Combine other severe rheumatic diseases: such as systemic lupus erythematosus, systemic sclerosis, dermatomyositis, etc. 2. Confirmed clinical cardiovascular diseases: History of definite myocardial infarction, unstable angina pectoris, coronary artery revascularization (stent or bypass); definite history of ischemic or hemorrhagic stroke; symptomatic peripheral artery disease; 3. Patients with previous high blood sugar and high blood lipids; at the time of enrollment, fasting blood glucose was >= 7.0 mmol/L and low-density lipoprotein was > 3.4 mmol/L; 4. History of drug use (which may interfere with the atherosclerotic process): Within 3 months prior to enrollment, use of glucocorticoids or non-steroidal anti-inflammatory drugs; within 3 months prior to enrollment, use of or being on any drugs known to significantly affect lipid metabolism or have clear vascular protective effects (statins, fibrates, high-dose fish oil, etc.);

Design outcomes

Primary

MeasureTime frame
The change in carotid intima-media thickness (CIMT) relative to the baseline at 12 months;

Secondary

MeasureTime frame
Changes in the levels of serum TC, TG, HDL-C, LDL-C, blood glucose, insulin, IL-6, CRP, TNF-a.;

Countries

China

Contacts

Public ContactFeng Tingting

Shanghai General Hospital

ycttfeng@163.com+86 21 6324 0090

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026