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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Takayasu Arteritis
• Intervention / Treatment: Drug: Tofacitinib 5 MG; Other: Placebo of prednisolone; Drug: Prednisolone; Other: Placebo of tofacitinib 5mg

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xinping Tian, MD; Phone Number: +86-13691165939; Email: tianxp6@126.com
• Study Contact Backup: Name: Jing Li, MD; Phone Number: +86-13020061363; Email: lijing6515@pumch.cn

Study Locations

• China
  • Beijing, China, 100730
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Shi Rong, MD; Phone Number: 86-13601248311; Email: rongshipumch@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese SLE Treatment And Research Group
• Investigators: Principal Investigator: Xinping Tian, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2023
• Primary Completion (Anticipated): July 20, 2025
• Study Completion (Anticipated): July 20, 2025

Study Registration Dates

• First Submitted: February 19, 2023
• First Submitted That Met QC Criteria: February 19, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 19, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Tofacitinib; prednisolone
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Vasculitis; Skin Diseases, Vascular; Aortic Diseases; Arteritis; Takayasu Arteritis; Aortic Arch Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Protein Kinase Inhibitors; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Tofacitinib
• Other Study ID Numbers: CSTAR-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No