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

Sponsor

Chinese SLE Treatment And Research Group (Other)

Overall Status

Recruiting

CT.gov ID

NCT05749666

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Takayasu Arteritis	Drug: Tofacitinib 5 MG Drug: Prednisolone Other: Placebo of tofacitinib 5mg Other: Placebo of prednisolone	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 20, 2023

Anticipated Primary Completion Date :

Jul 20, 2025

Anticipated Study Completion Date :

Jul 20, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tofacitinib group Tofacitinib 5mg BID taken orally for 24 weeks and placebo of prednisolone taken daily according to preset tapering protocol during same period	Drug: Tofacitinib 5 MG Tofacitinib 5 MG BID taken orally for 24 weeks Other: Placebo of prednisolone Placebo of prednisolone taken daily according to preset tapering protocol for 24 weeks
Active Comparator: Prednisolone group Prednisolone taken daily according to preset tapering protocol and placebo of tofacitinib 5mg BID taken orally for 24 weeks	Drug: Prednisolone Prednisolone taken daily according to preset tapering protocol Other: Placebo of tofacitinib 5mg Placebo of tofacitinib 5mg BID taken orally for 24 weeks

Arm

Intervention/Treatment

Experimental: Tofacitinib group

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

Drug: Tofacitinib 5 MG

Tofacitinib 5 MG BID taken orally for 24 weeks

Other: Placebo of prednisolone

Placebo of prednisolone taken daily according to preset tapering protocol for 24 weeks

Active Comparator: Prednisolone group

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

Drug: Prednisolone

Prednisolone taken daily according to preset tapering protocol

Other: Placebo of tofacitinib 5mg

Placebo of tofacitinib 5mg BID taken orally for 24 weeks

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of patients with partial response [week 24]
Percentage of patients with partial response at week 24
Percentage of patients with adverse events due to treatment of tofacitinib [24 weeks]
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 [24 weeks]
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 [week 24]
Percentage of patients with progress disease, stable disease, and improved disease demonstrated by CTA, MRI or Doppler at week 24
Intervention procedures [24 weeks]
Percentage of patients who require intervention procedures during the study period
Complication of Takayasu's arteritis [24 weeks]
Complication of Takayasu's arteritis happened during 24 weeks
Glucocorticoid toxicity index [week 24]
Glucocorticoid toxicity index at week 24 which indicate the toxicity of prednisolone.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.