NCT02981979

Takayasu Arteritis Clinical Trial in China

Comparison of the Efficacy and Safety of Leflunomide Versus Placebo Combined With Basic Prednisone Therapy in Patients With Active Takayasu Arteritis: a Randomized Double-blind Controlled Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Jiang lindi · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy and safety of Leflunomide (LEF) versus placebo combined with prednisone for active Takayasu arteritis (TAK) in Chinese population.

Detailed description

Takayasu arteritis (TAK) is a rare form of large-vessel vasculitis, characterized by immune -induced vascular inflammation, resulting in the stenosis and occlusion of blood vessels \[1\]. TAK is observed predominantly in Asian females under 40 years of age \[2, 3\]. The stenosis or occlusion of blood vessels can cause severe ischemic events (e.g., acute myocardial infarction, stroke, death) involving multiple organs. Patients with TAK experience impaired quality of life \[4\] and face a significantly higher risk of death compared with that in the sex- and age-matched general population, with a standardized mortality ranging from 2.7 to 17.3 \[5, 6, 7\]. Thus, timely and efficacious treatment is important to improve the prognosis in such a young population. Glucocorticoids (GCs) are the first-line therapy for active TAK \[8, 9\]. High-dose GCs are initially efficacious. However, disease recurrence can occur in approximately 60% patients during the GCs tapering \[10, 11\]. Prolonged use of GCs is associated with significant toxicity, including glucose-metabolism disorders, cardiovascular adverse events (AEs), and osteoporosis \[12, 13\]. Therefore, immunosuppressive therapy is required to minimize the dose and duration of GC exposure \[8, 9\]. Conventional immunosuppressants have been recommended as GC-tapering agents for active TAK, whereas biological agents are recommended in refractory cases \[8, 9\]. Most previous studies focused on TAK treatment have been observational, only five randomized clinical trials (RCTs) are found, among which, just one study reported the effect of conventional immunosuppressants mycophenolate \[14, 15, 16, 17, 18\]. Thus, high-quality evidence to support therapeutic options of conventional immunosuppressants is very limited. Leflunomide (LEF) is a conventional immunosuppressant \[19\], which has shown satisfied GC-tapering effects in the treatment of giant cell arteritis, another large vessel vasculitis, in several observational studies \[20, 21, 22\]. In 2012, the first open-label study of 14 TAK patients demonstrated that 70% of patients could achieve at least partial clinical remission, and the GC dose could be reduced by 50% during LEF treatment \[23\]. Since then, several observational cohort or case-control studies have reported the efficacy of LEF for active TAK \[24, 25, 26, 27, 28, 29\]. A most recent study reported a comparable complete response rate of LEF (78%) versus adalimumab (88%) at 15-month follow-up \[30\]. Thus, LEF would be a promising alternative treatment for TAK, but evidence from RCTs is lacking. We conducted this multicenter, randomized, double-blind, placebo-controlled trial to investigate the efficacy and safety of LEF versus placebo combined with prednisone for active TAK, namely "Takayasu arteritis clinical trial in China" (TACTIC; ClinicalTrials.gov identifier: NCT02981979).

Conditions

• Takayasu Arteritis

Interventions

Type	Name	Description
DRUG	Leflunomide(LEF)	Leflunomide: For LEF arm, 20mg per day, p.o. through the whole study. For placebo group, 20mg per day, p.o. from week 25 to week 52.
DRUG	Prednisone Acetate Tablets	Prednisone (5mg/tab): basic therapy, start with 0.6mg/kg/d and maintained for 4 weeks, then reducing 5mg every 2 weeks until 10mg per day.
DRUG	Placebos	2 tabs/d used in placebo arm for the first 24 weeks.

Timeline

• Start date: 2016-12-22
• Primary completion: 2022-05-22
• Completion: 2022-11-22
• First posted: 2016-12-05
• Last updated: 2025-04-24

Locations

6 sites across 1 country: China