Comparison of Tofacitinib and Prednisolone in the Treatment of Active Takayasu's Arteritis

Phase 3

Recruiting

• Conditions: Takayasu Arteritis
• Interventions: Drug: Tofacitinib 5 MG; Drug: Prednisolone; Other: Placebo of prednisolone; Other: Placebo of tofacitinib 5mg

• Registration Number: NCT05749666
• Lead Sponsor: Chinese SLE Treatment And Research Group

Brief Summary

This is a prospective, double-blinded, single center, randomized clinical trial. It compares the clinical efficacy and safety of thees 2 drugs in the treatment of active Takayasu's arteritis patients.

Detailed Description

In this study, 40 Takayasu's arteritis patients with active disease will be enrolled. Patients are randomized into the tofacitinib treatment group and prednisolone treatment group. Patients will follow the same reduction steps for prednisolone and its placebo. The primary end point is the percentage of patients who are in complete response at week 24.

The efficacy will be evaluated at week 4, 12 and 24. Safety is also monitored during the study.

Study Timeline

• Study Start: 2023-01-20
• Status Verified: 2023-02
• Study First Submitted: 2023-02-19
• Study First Submitted QC: 2023-02-19
• Last Update Submitted: 2023-02-19
• Study First Posted: 2023-03-01
• Last Update Posted: 2023-03-01
• Primary Completion: 2025-07-20
• Study Completion: 2025-07-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients aged between 18-65 years old;
2. Fulfilled the classification criteria of Takayasu's arteritis by ACR 1990;
3. Active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018 or Kerr's criteria by NIH;
4. Patients who signed the informed consent form.

Exclusion Criteria

1. Patients who failed or intolerant to either tofacitinib or its similar drugs;
2. Patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits;
3. Not well controlled diabetes;
4. Moderate and severe hyperlipedimia;
5. Patients with history of thrombus;
6. Uncontrolled heart failure od renal dysfunction (eGFR <30ml/min);
7. Patients with active infection, including tuberculosis, hepatitis B and C, HIV infection, bacterial or fungal infection;
8. Upper GI bleeding happened in 3 months before enrollment;
9. Refractory hypertension;
10. Pregnant or intended to be pregnant recently;
11. Severe coronary artery involvement demonstrated by CTA;
12. Severe cranial or cervical or renal artery diseases that need surgery;
13. Patients that should not be included judged by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tofacitinib group	Tofacitinib 5 MG	Tofacitinib 5mg BID taken orally for 24 weeks and placebo of prednisolone taken daily according to preset tapering protocol during same period
Tofacitinib group	Placebo of prednisolone	Tofacitinib 5mg BID taken orally for 24 weeks and placebo of prednisolone taken daily according to preset tapering protocol during same period
Prednisolone group	Placebo of tofacitinib 5mg	Prednisolone taken daily according to preset tapering protocol and placebo of tofacitinib 5mg BID taken orally for 24 weeks
Prednisolone group	Prednisolone	Prednisolone taken daily according to preset tapering protocol and placebo of tofacitinib 5mg BID taken orally for 24 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of patients with complete response	week 24	Percentage of patients with complete response at week 24

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with adverse events due to treatment of tofacitinib	24 weeks	Percentage of patients with adverse events due to treatment of tofacitinib at week 24
Percentage of patients with progression, no change, and improvement in vessel image at the end of study	week 24	Percentage of patients with progress disease, stable disease, and improved disease demonstrated by CTA, MRI or Doppler at week 24
Percentage of patients with partial response	week 24	Percentage of patients with partial response at week 24
Percentage of patients with adverse events due to treatment of prednisolone	24 weeks	Percentage of patients with adverse events due to treatment of prednisolone at week 24
Intervention procedures	24 weeks	Percentage of patients who require intervention procedures during the study period
Glucocorticoid toxicity index	week 24	Glucocorticoid toxicity index at week 24 which indicate the toxicity of prednisolone.
Complication of Takayasu's arteritis	24 weeks	Complication of Takayasu's arteritis happened during 24 weeks

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China