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

Takayasu Arteritis Clinical Trial

— ADATOFTAK  

Official title:

An Open-label，Randomized, Controlled, Multicenter Study of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05151848
• Other study ID #: CSTAR-007
• Status: Recruiting
• Phase: Phase 4
• Start date: January 5, 2022
• Est. completion date: January 15, 2026

Study information

• Verified date: July 2023
• Source: Chinese SLE Treatment And Research Group
• Contact: Xinping Tian, MD
• Phone: 8613691165939
• Email: tianxp6[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 15, 2026
• Est. primary completion date: January 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arteritis
• Takayasu Arteritis

Intervention

Drug:
• Adalimumab Injection
Adalimumab Injection injected subcutaneously every other week for 78 weeks
• Tofacitinib 5 MG
Tofacitinib 5 MG BID taken orally for 78 weeks

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing
China	Beijing Shijitan Hospital	Beijing
China	Beijing Xuanwu Hospital	Beijing
China	The General Hospital of the People's Liberation Army	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese SLE Treatment And Research Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients with complete response	percentage of patients with complete response at week 78	week 78
Secondary	percentage of patients with partial response	percentage of patients with partial response at week 78	week 78
Secondary	Percentage of patients with image progression at the end of study	percentage of patients with progress disease demonstrated by CTA or Doppler at week 78	week 78
Secondary	adverse events	safety profile of both Adalimumab and Tofacitinib treatment group	78 weeks
Secondary	intervention procedures	percentage of patients who require intervention procedures during the study period	78 weeks