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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tofacitinib group | Experimental | Tofacitinib 5mg BID taken orally for 24 weeks and placebo of prednisolone taken daily according to preset tapering protocol during same period |
|
| Prednisolone group | Active Comparator | Prednisolone taken daily according to preset tapering protocol and placebo of tofacitinib 5mg BID taken orally for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib 5 MG | Drug | Tofacitinib 5 MG BID taken orally for 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with complete response | Percentage of patients with complete response at week 24 | week 24 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinping Tian, MD | Contact | +86-13691165939 | tianxp6@126.com | |
| Jing Li, MD | Contact | +86-13020061363 | lijing6515@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xinping Tian, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | 100730 | China |
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| ID | Term |
|---|---|
| D013625 | Takayasu Arteritis |
| ID | Term |
|---|---|
| D001015 | Aortic Arch Syndromes |
| D001018 | Aortic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C479163 | tofacitinib |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Prednisolone |
| Drug |
Prednisolone taken daily according to preset tapering protocol |
|
| Placebo of tofacitinib 5mg | Other | Placebo of tofacitinib 5mg BID taken orally for 24 weeks |
|
| Placebo of prednisolone | Other | Placebo of prednisolone taken daily according to preset tapering protocol for 24 weeks |
|
| 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 |
| D001167 |
| Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |