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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-20

Study Completion Date

2025-07-20

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.

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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.

Conditions

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Takayasu Arteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tofacitinib group

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

Group Type EXPERIMENTAL

Tofacitinib 5 MG

Intervention Type DRUG

Tofacitinib 5 MG BID taken orally for 24 weeks

Placebo of prednisolone

Intervention Type OTHER

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

Prednisolone group

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

Group Type ACTIVE_COMPARATOR

Prednisolone

Intervention Type DRUG

Prednisolone taken daily according to preset tapering protocol

Placebo of tofacitinib 5mg

Intervention Type OTHER

Placebo of tofacitinib 5mg BID taken orally for 24 weeks

Interventions

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Tofacitinib 5 MG

Tofacitinib 5 MG BID taken orally for 24 weeks

Intervention Type DRUG

Prednisolone

Prednisolone taken daily according to preset tapering protocol

Intervention Type DRUG

Placebo of tofacitinib 5mg

Placebo of tofacitinib 5mg BID taken orally for 24 weeks

Intervention Type OTHER

Placebo of prednisolone

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No