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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Takayasu Arteritis

Intervention / Treatment
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* Drug: Tofacitinib 5 MG
* Drug: Prednisolone
* Other: Placebo of tofacitinib 5mg
* Other: Placebo of prednisolone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tofacitinib group<br>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<br>* Tofacitinib 5 MG BID taken orally for 24 weeks<br>Other: Placebo of prednisolone<br>* Placebo of prednisolone taken daily according to preset tapering protocol for 24 weeks<br>|
| Active Comparator: Prednisolone group<br>Prednisolone taken daily according to preset tapering protocol and placebo of tofacitinib 5mg BID taken orally for 24 weeks | Drug: Prednisolone<br>* Prednisolone taken daily according to preset tapering protocol<br>Other: Placebo of tofacitinib 5mg<br>* Placebo of tofacitinib 5mg BID taken orally for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with complete response | Percentage of patients with complete response at week 24 | week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with partial response | Percentage of patients with partial response at week 24 | 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 | 24 weeks | 
| 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 | 
| 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 | 
| Intervention procedures | Percentage of patients who require intervention procedures during the study period | 24 weeks | 
| Complication of Takayasu's arteritis | Complication of Takayasu's arteritis happened during 24 weeks | 24 weeks | 
| Glucocorticoid toxicity index | Glucocorticoid toxicity index at week 24 which indicate the toxicity of prednisolone. | week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tofacitinib, prednisolone