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The main objective of this study is to evaluate the efficacy of upadacitinib in combination with a corticosteroid taper regimen compared to placebo in combination with a corticosteroid taper regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 2: Placebo for Upadacitinib | Experimental | Participants will be administered placebo once daily (QD) along with prednisolone. |
|
| Arm 1: Upadacitinib | Experimental | Participants will be administered updadacitinib once daily (QD) along with prednisolone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upadacitinib | Drug | Upadacitinib will be administered as oral tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Relapse of Takayasu Arteritis (TAK) From Baseline through End of the Double-Blind (DB) Period | Relapse of TAK is defined as the presence of signs or symptoms as judged by the investigator for at least 2 of the following categories: objective systemic symptoms, subjective systemic symptoms, elevated inflammation markers, vascular signs and symptoms, or ischemic symptoms OR where the criteria are met based on one category per protocol definition of relapse of TAK. | Up to occurrence of 40 events (approximately 52 months) |
| Number of Participants with Adverse Events (AEs) | An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Up to approximately 58 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Relapse of Takayasu Arteritis (TAK) by Kerr Criteria From Baseline through End of the DB Period | Kerr criteria for relapse are defined as the presence of signs or symptoms as judged by the investigator for at least 2 of the following categories: objective or subjective systemic symptoms, elevated inflammation markers, vascular or ischemic signs and symptoms, or worsening in imaging assessment due to TAK. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundación Sanatorio Guemes /ID# 249675 | Ciudad Autonoma Buenos Aires | Buenos Aires | 1180 | Argentina | ||
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Placebo for Upadacitinib | Drug | Placebo for upadacitinib will be administered as oral tablet |
|
| Prednisolone | Drug | Prednisolone will be administered as oral tablet |
|
| Up to occurrence of 40 events (approximately 52 months) |
| Time to Worsening of Imaging Assessment Due to Takayasu Arteritis (TAK) From Baseline through End of the DB Period | Imaging with computed tomography angiogram (CTA). | Up to occurrence of 40 events (approximately 52 months) |
| Hospital Italiano La Plata /ID# 249269 |
| La Plata |
| Buenos Aires |
| 1900 |
| Argentina |
| SER - Servicos Especializados em Reumatologia da Bahia /ID# 243125 | Salvador | Estado de Bahia | 40150-150 | Brazil |
| CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 242517 | Juiz de Fora | Minas Gerais | 36010-570 | Brazil |
| CETI - Centro de Estudos em Terapias Inovadoras /ID# 242502 | Curitiba | Paraná | 80030-110 | Brazil |
| LMK Sevicos Medicos S/S /ID# 240645 | Porto Alegre | Rio Grande do Sul | 90480-000 | Brazil |
| Hospital do Rim /ID# 240380 | São Paulo | 04038-002 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao /ID# 241175 | São Paulo | 05403-000 | Brazil |
| Xuanwu Hospital Capital Medical University /ID# 248104 | Beijing | Beijing Municipality | 100053 | China |
| Guangdong Provincial Peoples Hospital /ID# 248350 | Guangzhou | Guangdong | 510080 | China |
| Shenzhen People's Hospital /ID# 248347 | Shenzhen | Guangdong | 518020 | China |
| First Affiliated Hospital of China Medical University /ID# 248107 | Shenyang | Liaoning | 110001 | China |
| Zhongshan Hospital Fudan University /ID# 247159 | Shanghai | Shanghai Municipality | 200032 | China |
| Chiba University Hospital /ID# 214932 | Chiba | Chiba | 260-8677 | Japan |
| Ehime University Hospital /ID# 215424 | Toon-shi | Ehime | 791-0295 | Japan |
| Maebashi Red Cross Hospital /ID# 230513 | Maebashi | Gunma | 371-0811 | Japan |
| Duplicate_Hokkaido University Hospital /ID# 215066 | Sapporo | Hokkaido | 060-8648 | Japan |
| University of Tsukuba Hospital /ID# 215318 | Tsukuba | Ibaraki | 305-8576 | Japan |
| Kagawa University Hospital /ID# 214776 | Kita-gun | Kagawa-ken | 761-0793 | Japan |
| St Marianna University School Of Medicine /ID# 214535 | Kawasaki-shi | Kanagawa | 216-8511 | Japan |
| Yokohama City University Hospital /ID# 214345 | Yokohama | Kanagawa | 236-0004 | Japan |
| Duplicate_Kyoto University Hospital /ID# 215128 | Kyoto | Kyoto | 606-8507 | Japan |
| Tohoku University Hospital /ID# 214066 | Sendai | Miyagi | 9808574 | Japan |
| Miyagi Children's Hospital /ID# 248390 | Sendai | Miyagi | 989-3126 | Japan |
| Nagano Red Cross Hospital /ID# 214537 | Nagano | Nagano | 380-8582 | Japan |
| Duplicate_Nagasaki University Hospital /ID# 215683 | Nagasaki | Nagasaki | 852-8501 | Japan |
| Okayama University Hospital /ID# 214499 | Okayama | Okayama-ken | 700-8558 | Japan |
| National Hospital Organization Osaka Minami Medical Center /ID# 228779 | Kawachinagano Shi | Osaka | 586-8521 | Japan |
| Kindai University Hospital /ID# 216491 | Sakai-shi | Osaka | 590-0197 | Japan |
| National Cerebral and Cardiovascular Center /ID# 214061 | Suita-shi | Osaka | 564-8565 | Japan |
| Juntendo University Hospital /ID# 214292 | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Institute of Science Tokyo Hospital /ID# 214138 | Bunkyo-ku | Tokyo | 113-8519 | Japan |
| St. Lukes International Hospital /ID# 214067 | Chuo-ku | Tokyo | 104-8560 | Japan |
| Duplicate_Keio University Hospital /ID# 214905 | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| National Center for Global Health and Medicine /ID# 214931 | Shinjuku-ku | Tokyo | 162-8655 | Japan |
| Duplicate_Tokyo Women's Medical University Hospital /ID# 215129 | Shinjuku-ku | Tokyo | 162-8666 | Japan |
| Seoul National University Hospital /ID# 213844 | Seoul | Seoul Teugbyeolsi | 03080 | South Korea |
| Hanyang University Seoul Hospital /ID# 213842 | Seoul | Seoul Teugbyeolsi | 04763 | South Korea |
| Gangnam Severance Hospital /ID# 229543 | Seoul | Seoul Teugbyeolsi | 06273 | South Korea |
| The Catholic University of Korea, Seoul St. Marys Hospital /ID# 214566 | Seoul | Seoul Teugbyeolsi | 06591 | South Korea |
| Yonsei University Health System Severance Hospital /ID# 215643 | Seoul | 03722 | South Korea |
| Hacettepe University Faculty of Medicine /ID# 239845 | Ankara | 06100 | Turkey (Türkiye) |
| Ankara Univ Medical Faculty /ID# 240015 | Ankara | 06590 | Turkey (Türkiye) |
| Akdeniz University Faculty /ID# 239847 | Antalya | 06100 | Turkey (Türkiye) |
| Basaksehir Cam ve Sakura Sehir Hastanesi /ID# 239846 | Istanbul | 34480 | Turkey (Türkiye) |
| Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 239844 | Istanbul | 34899 | Turkey (Türkiye) |
| Ege University Medical Faculty /ID# 240139 | Izmir | 35040 | Turkey (Türkiye) |
| Necmettin Erbakan Universitesi /ID# 239848 | Meram Konya | 42080 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D013625 | Takayasu Arteritis |
| ID | Term |
|---|---|
| D001015 | Aortic Arch Syndromes |
| D001018 | Aortic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000613732 | upadacitinib |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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