Takayasu Arteritis
Conditions
Keywords
Tofacitinib, prednisolone
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.
Interventions
DRUGTofacitinib 5 MG
Tofacitinib 5 MG BID taken orally for 24 weeks
DRUGPrednisolone
Prednisolone taken daily according to preset tapering protocol
OTHERPlacebo of tofacitinib 5mg
Placebo of tofacitinib 5mg BID taken orally for 24 weeks
OTHERPlacebo of prednisolone
Placebo of prednisolone taken daily according to preset tapering protocol for 24 weeks
Sponsors
Chinese SLE Treatment And Research Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with complete response | week 24 | Percentage of patients with complete response at week 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with adverse events due to treatment of tofacitinib | 24 weeks | Percentage of patients with adverse events due to treatment of tofacitinib at week 24 |
| Percentage of patients with adverse events due to treatment of prednisolone | 24 weeks | Percentage of patients with adverse events due to treatment of prednisolone at week 24 |
| Percentage of patients with progression, no change, and improvement in vessel image at the end of study | week 24 | Percentage of patients with progress disease, stable disease, and improved disease demonstrated by CTA, MRI or Doppler at week 24 |
| Percentage of patients with partial response | week 24 | Percentage of patients with partial response at week 24 |
| Complication of Takayasu's arteritis | 24 weeks | Complication of Takayasu's arteritis happened during 24 weeks |
| Glucocorticoid toxicity index | week 24 | Glucocorticoid toxicity index at week 24 which indicate the toxicity of prednisolone. |
| Intervention procedures | 24 weeks | Percentage of patients who require intervention procedures during the study period |
Countries
China
Contacts
Primary ContactXinping Tian, MD
Backup ContactJing Li, MD
Outcome results
None listed