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

Primary Purpose

Takayasu Arteritis

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tofacitinib 5 MG
Prednisolone
Placebo of tofacitinib 5mg
Placebo of prednisolone
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 focused on measuring Tofacitinib, prednisolone

Eligibility Criteria

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

Inclusion Criteria: Patients aged between 18-65 years old; Fulfilled the classification criteria of Takayasu's arteritis by ACR 1990; Active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018 or Kerr's criteria by NIH; Patients who signed the informed consent form. Exclusion Criteria: Patients who failed or intolerant to either tofacitinib or its similar drugs; Patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits; Not well controlled diabetes; Moderate and severe hyperlipedimia; Patients with history of thrombus; Uncontrolled heart failure od renal dysfunction (eGFR <30ml/min); Patients with active infection, including tuberculosis, hepatitis B and C, HIV infection, bacterial or fungal infection; Upper GI bleeding happened in 3 months before enrollment; Refractory hypertension; Pregnant or intended to be pregnant recently; Severe coronary artery involvement demonstrated by CTA; Severe cranial or cervical or renal artery diseases that need surgery; Patients that should not be included judged by the investigator.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tofacitinib group

Prednisolone group

Arm Description

Tofacitinib 5mg BID taken orally for 24 weeks and placebo of prednisolone taken daily according to preset tapering protocol during same period

Prednisolone taken daily according to preset tapering protocol and placebo of tofacitinib 5mg BID taken orally for 24 weeks

Outcomes

Primary Outcome Measures

Percentage of patients with complete response
Percentage of patients with complete response at week 24

Secondary Outcome Measures

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

Full Information

First Posted
February 19, 2023
Last Updated
February 19, 2023
Sponsor
Chinese SLE Treatment And Research Group
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1. Study Identification

Unique Protocol Identification Number
NCT05749666
Brief Title
Comparison of Tofacitinib and Prednisolone in the Treatment of Active Takayasu's Arteritis
Acronym
TOFGCTAK
Official Title
A Prospective Randomized Double-blinded Controlled Single Center Clinical Study of the Efficacy and Safety for Tofacitinib Compared With Glucocorticoid in the Remission-reduction Treatment of Active Takayasu's Arteritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2023 (Actual)
Primary Completion Date
July 20, 2025 (Anticipated)
Study Completion Date
July 20, 2025 (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, 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tofacitinib group
Arm Type
Experimental
Arm Description
Tofacitinib 5mg BID taken orally for 24 weeks and placebo of prednisolone taken daily according to preset tapering protocol during same period
Arm Title
Prednisolone group
Arm Type
Active Comparator
Arm Description
Prednisolone taken daily according to preset tapering protocol and placebo of tofacitinib 5mg BID taken orally for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Tofacitinib 5 MG
Intervention Description
Tofacitinib 5 MG BID taken orally for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
Prednisolone taken daily according to preset tapering protocol
Intervention Type
Other
Intervention Name(s)
Placebo of tofacitinib 5mg
Intervention Description
Placebo of tofacitinib 5mg BID taken orally for 24 weeks
Intervention Type
Other
Intervention Name(s)
Placebo of prednisolone
Intervention Description
Placebo of prednisolone taken daily according to preset tapering protocol for 24 weeks
Primary Outcome Measure Information:
Title
Percentage of patients with complete response
Description
Percentage of patients with complete response at week 24
Time Frame
week 24
Secondary Outcome Measure Information:
Title
Percentage of patients with partial response
Description
Percentage of patients with partial response at week 24
Time Frame
week 24
Title
Percentage of patients with adverse events due to treatment of tofacitinib
Description
Percentage of patients with adverse events due to treatment of tofacitinib at week 24
Time Frame
24 weeks
Title
Percentage of patients with adverse events due to treatment of prednisolone
Description
Percentage of patients with adverse events due to treatment of prednisolone at week 24
Time Frame
24 weeks
Title
Percentage of patients with progression, no change, and improvement in vessel image at the end of study
Description
Percentage of patients with progress disease, stable disease, and improved disease demonstrated by CTA, MRI or Doppler at week 24
Time Frame
week 24
Title
Intervention procedures
Description
Percentage of patients who require intervention procedures during the study period
Time Frame
24 weeks
Title
Complication of Takayasu's arteritis
Description
Complication of Takayasu's arteritis happened during 24 weeks
Time Frame
24 weeks
Title
Glucocorticoid toxicity index
Description
Glucocorticoid toxicity index at week 24 which indicate the toxicity of prednisolone.
Time Frame
week 24

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; Active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018 or Kerr's criteria by NIH; Patients who signed the informed consent form. Exclusion Criteria: Patients who failed or intolerant to either tofacitinib or its similar drugs; Patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits; Not well controlled diabetes; Moderate and severe hyperlipedimia; Patients with history of thrombus; Uncontrolled heart failure od renal dysfunction (eGFR <30ml/min); Patients with active infection, including tuberculosis, hepatitis B and C, HIV infection, bacterial or fungal infection; Upper GI bleeding happened in 3 months before enrollment; Refractory hypertension; Pregnant or intended to be pregnant recently; Severe coronary artery involvement demonstrated by CTA; Severe cranial or cervical or renal artery diseases that need surgery; Patients that should not be included judged by the investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinping Tian, MD
Phone
+86-13691165939
Email
tianxp6@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Li, MD
Phone
+86-13020061363
Email
lijing6515@pumch.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinping Tian, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinping Tian, MD
Phone
86-13691165939
Email
tianxp6@126.com
First Name & Middle Initial & Last Name & Degree
Shi Rong, MD
Phone
86-13601248311
Email
rongshipumch@126.com
First Name & Middle Initial & Last Name & Degree
XInping Tian, MD

12. IPD Sharing Statement

Learn more about this trial

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

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