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
Overview
- Phase
- Phase 3
- Intervention
- Tofacitinib 5 MG
- Conditions
- Takayasu Arteritis
- Sponsor
- Chinese SLE Treatment And Research Group
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Percentage of patients with complete response
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
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.
Investigators
Xinping Tian
Professor of Medicine
Chinese SLE Treatment And Research Group
Eligibility Criteria
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;
Arms & Interventions
Tofacitinib group
Tofacitinib 5mg BID taken orally for 24 weeks and placebo of prednisolone taken daily according to preset tapering protocol during same period
Intervention: Tofacitinib 5 MG
Tofacitinib group
Tofacitinib 5mg BID taken orally for 24 weeks and placebo of prednisolone taken daily according to preset tapering protocol during same period
Intervention: Placebo of prednisolone
Prednisolone group
Prednisolone taken daily according to preset tapering protocol and placebo of tofacitinib 5mg BID taken orally for 24 weeks
Intervention: Prednisolone
Prednisolone group
Prednisolone taken daily according to preset tapering protocol and placebo of tofacitinib 5mg BID taken orally for 24 weeks
Intervention: Placebo of tofacitinib 5mg
Outcomes
Primary Outcomes
Percentage of patients with complete response
Time Frame: week 24
Percentage of patients with complete response at week 24
Secondary Outcomes
- Percentage of patients with adverse events due to treatment of tofacitinib(24 weeks)
- Percentage of patients with progression, no change, and improvement in vessel image at the end of study(week 24)
- Percentage of patients with partial response(week 24)
- Percentage of patients with adverse events due to treatment of prednisolone(24 weeks)
- Intervention procedures(24 weeks)
- Glucocorticoid toxicity index(week 24)
- Complication of Takayasu's arteritis(24 weeks)