search
Back to results

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

Primary Purpose

Takayasu Arteritis

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Adalimumab Injection
Tofacitinib 5 MG
Sponsored by
Chinese SLE Treatment And Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Takayasu Arteritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

  • Beijing Anzhen HospitalRecruiting
  • The General Hospital of the People's Liberation Army
  • Beijing Shijitan Hospital
  • Beijing Xuanwu Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Adalimumab group

Tofacitinib 5MG group

Arm Description

Adalimumab 40mg injected subcutaneously every 2 weeks for 78 weeks.

Tofacitinib 5mg BID taken orally for 78 weeks.

Outcomes

Primary Outcome Measures

percentage of patients with complete response
percentage of patients with complete response at week 78

Secondary Outcome Measures

percentage of patients with partial response
percentage of patients with partial response at 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
adverse events
safety profile of both Adalimumab and Tofacitinib treatment group
intervention procedures
percentage of patients who require intervention procedures during the study period

Full Information

First Posted
November 6, 2021
Last Updated
July 21, 2023
Sponsor
Chinese SLE Treatment And Research Group
search

1. Study Identification

Unique Protocol Identification Number
NCT05151848
Brief Title
Comparison of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis
Acronym
ADATOFTAK
Official Title
An Open-label，Randomized, Controlled, Multicenter Study of Adalimumab and Tofacitinib in the Treatment of Active Takayasu Arteritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
January 15, 2026 (Anticipated)
Study Completion Date
January 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese SLE Treatment And Research Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Takayasu Arteritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
open-label, multicenter,randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adalimumab group
Arm Type
Experimental
Arm Description
Adalimumab 40mg injected subcutaneously every 2 weeks for 78 weeks.
Arm Title
Tofacitinib 5MG group
Arm Type
Active Comparator
Arm Description
Tofacitinib 5mg BID taken orally for 78 weeks.
Intervention Type
Drug
Intervention Name(s)
Adalimumab Injection
Other Intervention Name(s)
An-jian-ning
Intervention Description
Adalimumab Injection injected subcutaneously every other week for 78 weeks
Intervention Type
Drug
Intervention Name(s)
Tofacitinib 5 MG
Other Intervention Name(s)
An-shu-zheng
Intervention Description
Tofacitinib 5 MG BID taken orally for 78 weeks
Primary Outcome Measure Information:
Title
percentage of patients with complete response
Description
percentage of patients with complete response at week 78
Time Frame
week 78
Secondary Outcome Measure Information:
Title
percentage of patients with partial response
Description
percentage of patients with partial response at week 78
Time Frame
week 78
Title
Percentage of patients with image progression at the end of study
Description
percentage of patients with progress disease demonstrated by CTA or Doppler at week 78
Time Frame
week 78
Title
adverse events
Description
safety profile of both Adalimumab and Tofacitinib treatment group
Time Frame
78 weeks
Title
intervention procedures
Description
percentage of patients who require intervention procedures during the study period
Time Frame
78 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged between 18-65 years old; Fulfilled the classification criteria of Takayasu's arteritis by ACR 1990; relapse active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018; Patients who signed the informed consent form. Exclusion Criteria: Patients who failed or intolerant to either adalimumab or tofacitinib; patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits; not well controlled diabetes; uncontrolled heart failure od renal dysfunction(eGFR<30ml/min); Patients with active infection,including tuberculosis, hepatitis B and C,HIV infection, bacteria or fungal infection; upper GI bleeding 3 months before enrolement; refractory hypertension; Pregnant or intended to be pregnant 3 months after the trial; Severe coronary artery involvement demonstrated by CTA; severe cranial or cervical or renal artery diseases that need surgery; Patients that should not be included by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinping Tian, MD
Phone
8613691165939
Ext
8613691165939
Email
tianxp6@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yunjiao Yang, MD
Phone
8613671313079
Ext
8613671313079
Email
yangyunjiao81@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zeng, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anzhen Hospital
City
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lili Pan, MD
Phone
13720021786
Email
lilypansxmu@sina.com
First Name & Middle Initial & Last Name & Degree
Taotao Li, MD
Phone
13621314886
Email
litaotao789@sina.com
Facility Name
The General Hospital of the People's Liberation Army
City
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Zhu, MD
Phone
13671105096
Email
jian_jzhu@126.com
First Name & Middle Initial & Last Name & Degree
Aihua Wan
Phone
13641380248
Email
284986094@qq.com
Facility Name
Beijing Shijitan Hospital
City
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuhua Wang, MD
Phone
18610276177
Email
wyhxxtt@163.com
First Name & Middle Initial & Last Name & Degree
Yawen Shen, MD
Phone
13051581579
Email
songajulia@163.com
Facility Name
Beijing Xuanwu Hospital
City
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Zhao, MD
Phone
13501164945
Email
zhaoyi_peking@163.com
First Name & Middle Initial & Last Name & Degree
Fang Kong, MD
Phone
13051116280
Email
kongfang90@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs