Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis

Phase 4

Recruiting

• Conditions: Takayasu Arteritis
• Interventions: Drug: Tofacitinib 5 MG; Drug: Adalimumab Injection

• Registration Number: NCT05151848
• Lead Sponsor: Chinese SLE Treatment And Research Group

Brief Summary

This is a prospective,open-labelled,multi-center,randomized clinical trial.It compares the clinical efficacy and safety of there 2 drugs in the treatment of relapse active Takayasu's arteritis patients.

Detailed Description

In this study, 100 relapse Takayasu's arteritis patients will be enrolled. Patients are randomized into the adalimumab treatment group and tofacitinib treatment.Patients will also be treated with reduced dose of glucocorticoid at the same time. The primary end point is the percentage of patients who are in complete response at week 12 and maintain in complete response at week 78.

The efficacy will be evaluated at week 12, 24, 36, 52 and 78. If the patient does not respond to one drug at week 24, then the investigator will shift the treatment to another intervention. Safety is also monitored during the study.

Study Timeline

• Study First Submitted: 2021-11-06
• Study First Submitted QC: 2021-11-26
• Study First Posted: 2021-12-09
• Study Start: 2022-01-05
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24
• Primary Completion: 2026-01-15
• Study Completion: 2026-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

1. Patients who failed or intolerant to either adalimumab or tofacitinib;
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. uncontrolled heart failure od renal dysfunction(eGFR<30ml/min);
5. Patients with active infection,including tuberculosis, hepatitis B and C,HIV infection, bacteria or fungal infection;
6. upper GI bleeding 3 months before enrolement;
7. refractory hypertension;
8. Pregnant or intended to be pregnant 3 months after the trial;
9. Severe coronary artery involvement demonstrated by CTA;
10. severe cranial or cervical or renal artery diseases that need surgery;
11. Patients that should not be included by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tofacitinib 5MG group	Tofacitinib 5 MG	Tofacitinib 5mg BID taken orally for 78 weeks.
Adalimumab group	Adalimumab Injection	Adalimumab 40mg injected subcutaneously every 2 weeks for 78 weeks.

Primary Outcome Measures

Name	Time	Method
percentage of patients with complete response	week 78	percentage of patients with complete response at week 78

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with image progression at the end of study	week 78	percentage of patients with progress disease demonstrated by CTA or Doppler at week 78
intervention procedures	78 weeks	percentage of patients who require intervention procedures during the study period
adverse events	78 weeks	safety profile of both Adalimumab and Tofacitinib treatment group
percentage of patients with partial response	week 78	percentage of patients with partial response at week 78

Trial Locations

Locations (4)

Beijing Xuanwu Hospital; 🇨🇳 Beijing, China

The General Hospital of the People's Liberation Army; 🇨🇳 Beijing, China

Beijing Anzhen Hospital; 🇨🇳 Beijing, China

Beijing Shijitan Hospital; 🇨🇳 Beijing, China