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

Takayasu Arteritis Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05749666
• Other study ID #: CSTAR-009
• Status: Recruiting
• Phase: Phase 3
• Start date: January 20, 2023
• Est. completion date: July 20, 2025

Study information

• Verified date: February 2023
• Source: Chinese SLE Treatment And Research Group
• Contact: Xinping Tian, MD
• Phone: +86-13691165939
• Email: tianxp6[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 20, 2025
• Est. primary completion date: July 20, 2025
• 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. Active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018 or Kerr's criteria by NIH;

4. Patients who signed the informed consent form.

Exclusion Criteria:

1. Patients who failed or intolerant to either tofacitinib or its similar drugs;

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. Moderate and severe hyperlipedimia;

5. Patients with history of thrombus;

6. Uncontrolled heart failure od renal dysfunction (eGFR <30ml/min);

7. Patients with active infection, including tuberculosis, hepatitis B and C, HIV infection, bacterial or fungal infection;

8. Upper GI bleeding happened in 3 months before enrollment;

9. Refractory hypertension;

10. Pregnant or intended to be pregnant recently;

11. Severe coronary artery involvement demonstrated by CTA;

12. Severe cranial or cervical or renal artery diseases that need surgery;

13. Patients that should not be included judged by the investigator.

Related Conditions & MeSH terms

• Arteritis
• Takayasu Arteritis

Intervention

Drug:
• Tofacitinib 5 MG
Tofacitinib 5 MG BID taken orally for 24 weeks
• Prednisolone
Prednisolone taken daily according to preset tapering protocol

Other:
• Placebo of tofacitinib 5mg
Placebo of tofacitinib 5mg BID taken orally for 24 weeks
• Placebo of prednisolone
Placebo of prednisolone taken daily according to preset tapering protocol for 24 weeks

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	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 24	week 24
Secondary	Percentage of patients with partial response	Percentage of patients with partial response at week 24	week 24
Secondary	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	24 weeks
Secondary	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	24 weeks
Secondary	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	week 24
Secondary	Intervention procedures	Percentage of patients who require intervention procedures during the study period	24 weeks
Secondary	Complication of Takayasu's arteritis	Complication of Takayasu's arteritis happened during 24 weeks	24 weeks
Secondary	Glucocorticoid toxicity index	Glucocorticoid toxicity index at week 24 which indicate the toxicity of prednisolone.	week 24