Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis (ADATOFTAK)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Takayasu Arteritis
• Intervention / Treatment: Drug: Adalimumab Injection; Drug: Tofacitinib 5 MG

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xinping Tian, MD; Phone Number: 8613691165939 8613691165939; Email: tianxp6@126.com
• Study Contact Backup: Name: Yunjiao Yang, MD; Phone Number: 8613671313079 8613671313079; Email: yangyunjiao81@163.com

Study Locations

• China
  • Beijing, China, 100000
    • Recruiting
    • Beijing Anzhen Hospital
    • Contact: Lili Pan, MD; Phone Number: 13720021786; Email: lilypansxmu@sina.com
    • Contact: Taotao Li, MD; Phone Number: 13621314886; Email: litaotao789@sina.com
  • Beijing, China, 100000
    • Not yet recruiting
    • The General Hospital of the People's Liberation Army
    • Contact: Jian Zhu, MD; Phone Number: 13671105096; Email: jian_jzhu@126.com
    • Contact: Aihua Wan; Phone Number: 13641380248; Email: 284986094@qq.com
  • Beijing, China, 100053
    • Not yet recruiting
    • Beijing Shijitan Hospital
    • Contact: Yuhua Wang, MD; Phone Number: 18610276177; Email: wyhxxtt@163.com
    • Contact: Yawen Shen, MD; Phone Number: 13051581579; Email: songajulia@163.com
  • Beijing, China, 100053
    • Not yet recruiting
    • Beijing Xuanwu Hospital
    • Contact: Yi Zhao, MD; Phone Number: 13501164945; Email: zhaoyi_peking@163.com
    • Contact: Fang Kong, MD; Phone Number: 13051116280; Email: kongfang90@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adalimumab group; Adalimumab 40mg injected subcutaneously every 2 weeks for 78 weeks.	Drug: Adalimumab Injection; Adalimumab Injection injected subcutaneously every other week for 78 weeks; Other Names: An-jian-ning
Active Comparator: Tofacitinib 5MG group; Tofacitinib 5mg BID taken orally for 78 weeks.	Drug: Tofacitinib 5 MG; Tofacitinib 5 MG BID taken orally for 78 weeks; Other Names: An-shu-zheng

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of patients with complete response	percentage of patients with complete response at week 78	week 78

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of patients with partial response	percentage of patients with partial response at week 78	week 78
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
adverse events	safety profile of both Adalimumab and Tofacitinib treatment group	78 weeks
intervention procedures	percentage of patients who require intervention procedures during the study period	78 weeks

Collaborators and Investigators

• Sponsor: Chinese SLE Treatment And Research Group
• Investigators: Principal Investigator: Xiaofeng Zeng, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): January 15, 2026

Study Registration Dates

• First Submitted: November 6, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Vasculitis; Skin Diseases, Vascular; Aortic Diseases; Arteritis; Takayasu Arteritis; Aortic Arch Syndromes; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Protein Kinase Inhibitors; Tumor Necrosis Factor Inhibitors; Janus Kinase Inhibitors; Adalimumab; Tofacitinib
• Other Study ID Numbers: CSTAR-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No