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This is a prospective,open-labelled,multi-center,randomized clinical trial.It compares the clinical efficacy and safety of there 2 drugs in the treatment of relapse active Takayasu's arteritis patients.
In this study, 100 relapse Takayasu's arteritis patients will be enrolled. Patients are randomized into the adalimumab treatment group and tofacitinib treatment.Patients will also be treated with reduced dose of glucocorticoid at the same time. The primary end point is the percentage of patients who are in complete response at week 12 and maintain in complete response at week 78.
The efficacy will be evaluated at week 12, 24, 36, 52 and 78. If the patient does not respond to one drug at week 24, then the investigator will shift the treatment to another intervention. Safety is also monitored during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab group | Experimental | Adalimumab 40mg injected subcutaneously every 2 weeks for 78 weeks. |
|
| Tofacitinib 5MG group | Active Comparator | Tofacitinib 5mg BID taken orally for 78 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab Injection | Drug | Adalimumab Injection injected subcutaneously every other week for 78 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients with complete response | percentage of patients with complete response at week 78 | week 78 |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of patients with partial response | percentage of patients with partial response at week 78 | week 78 |
| Percentage of patients with image progression at the end of study | percentage of patients with progress disease demonstrated by CTA or Doppler at week 78 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinping Tian, MD | Contact | 8613691165939 | 8613691165939 | tianxp6@126.com |
| Yunjiao Yang, MD | Contact | 8613671313079 | 8613671313079 | yangyunjiao81@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaofeng Zeng, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Recruiting | Beijing | 100000 | 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 |
|---|---|
| D000068879 | Adalimumab |
| C479163 | tofacitinib |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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open-label, multicenter,randomized trial
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| Tofacitinib 5 MG | Drug | Tofacitinib 5 MG BID taken orally for 78 weeks |
|
|
| week 78 |
| adverse events | safety profile of both Adalimumab and Tofacitinib treatment group | 78 weeks |
| intervention procedures | percentage of patients who require intervention procedures during the study period | 78 weeks |
| The General Hospital of the People's Liberation Army | Not yet recruiting | Beijing | 100000 | China |
|
| Beijing Shijitan Hospital | Not yet recruiting | Beijing | 100053 | China |
|
| Beijing Xuanwu Hospital | Not yet recruiting | Beijing | 100053 | China |
|
| D001167 |
| Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |