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

Chinese SLE Treatment And Research Group

Status and phase: Enrolling; Phase 3

Conditions: Takayasu Arteritis

Treatments: Other: Placebo of tofacitinib 5mg; Other: Placebo of prednisolone; Drug: Prednisolone; Drug: Tofacitinib 5 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05749666

CSTAR-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Tofacitinib group

Experimental group

Description:

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

Treatment:

Other: Placebo of prednisolone

Drug: Tofacitinib 5 MG

Prednisolone group

Active Comparator group

Description:

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

Treatment:

Other: Placebo of tofacitinib 5mg

Drug: Prednisolone