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To evaluate the efficacy of Brodalumab in axSpA (ankylosing spondylitis [AS] and non-radiographic axial spondyloarthritis [nr-axSpA]) subjects compared to placebo, as measured by the proportion of axSpA subjects achieving an Assessment of SpondyloArthritis international Society (ASAS) 40 response at week 16.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brodalumab | Experimental | Brodalumab administered SC |
|
| Placebo | Placebo Comparator | Placebo administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brodalumab | Drug | Administered Brodalumab by subcutaneous (SC) injection until week 66. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of ASAS 40 in axSpA subjects | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of ASAS 40 in AS subjects | Week 16 | |
| Percentage of ASAS 40 in nr-axSpA subjects | Week 16 | |
| Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP change from baseline in axSpA subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujita Health University Hpspital | Aichi | Japan | ||||
| Tokyo Women's Medical University Yachiyo Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36130275 | Derived | Kim TH, Kishimoto M, Wei JC, Jeong H, Nozaki A, Kobayashi S. Brodalumab, an anti-interleukin-17 receptor A monoclonal antibody, in axial spondyloarthritis: 68-week results from a phase 3 study. Rheumatology (Oxford). 2023 May 2;62(5):1851-1859. doi: 10.1093/rheumatology/keac522. | |
| 33827787 | Derived | Wei JC, Kim TH, Kishimoto M, Ogusu N, Jeong H, Kobayashi S; 4827-006 study group. Efficacy and safety of brodalumab, an anti-IL17RA monoclonal antibody, in patients with axial spondyloarthritis: 16-week results from a randomised, placebo-controlled, phase 3 trial. Ann Rheum Dis. 2021 Aug;80(8):1014-1021. doi: 10.1136/annrheumdis-2020-219406. Epub 2021 Apr 7. |
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| Placebo |
| Drug |
Administered Placebo by subcutaneous (SC) injection until week 16. Administered Brodalumab by SC injection from week 17 until week 66. |
|
| Week 16 |
| Number of adverse events | Up to week 68 |
| Number of patients exposed to anti-KHK4827 antibodies | Pre-dose,Week 16,Week 32,Week 48,Week 68 or End of study |
| Serum KHK4827 concentration | pre-dose、Week 1、Week 2、Week 4、Week 8、Week 12、Week 14、Week 16、Week 24、Week 28、Week 32 |
| Chiba |
| Japan |
| Chihaya Hospital | Fukuoka | Japan |
| Fukuoka University Hospital | Fukuoka | Japan |
| Kyusyu University Hospital | Fukuoka | Japan |
| Hokkaido University Hospital | Hokkaido | Japan |
| Katayama Seikeigeka Rheumatism Clinic | Hokkaido | Japan |
| Hyogo College of Medicine | Hyōgo | Japan |
| Kagawa University Hospital | Kagawa | Japan |
| Kochi Medical School Hospital | Kochi | Japan |
| Sasebo Chuo Hospital | Nagasaki | Japan |
| Tenri Hospital | Nara | Japan |
| Okayama Saiseikai Outpatient Centerl Hospital | Okayama | Japan |
| Okinawa Prefectural Chubu Hospital | Okinawa | Japan |
| Tomishiro Central Hospital | Okinawa | Japan |
| National Hosptal Organization Osaka Minami Medical Center | Osaka | Japan |
| Osaka City General Hospital | Osaka | Japan |
| Osaka City University Hospital | Osaka | Japan |
| Osaka University Hospital | Osaka | Japan |
| Yukioka Hospital | Osaka | Japan |
| Juntendo University Hospital | Tokyo | Japan |
| St.Luke's International Hospital | Tokyo | Japan |
| Toho University Ohashi Medical Center | Tokyo | Japan |
| Toho University Omori Medical Center | Tokyo | Japan |
| Tokyo Women's Medical University Hospital | Tokyo | Japan |
| Pusan National University Hospital | Busan | South Korea |
| Daegu Catholic University Medical Center | Daegu | South Korea |
| Chungnam National University Hospital | Daejeon | South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| Ajou University Hospital | Gyeonggi-do | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | South Korea |
| Inha University Hospital | Incheon | South Korea |
| Hanyang University Seoul Hospital | Seoul | South Korea |
| Konkuk University Medical Center | Seoul | South Korea |
| KyungHee University Hospital | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| The catholic university of korea Seoul St.mary's Hospital | Seoul | South Korea |
| Chang Gung Medical Foundation, Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | Taiwan |
| Kaohsiung Veterans General Hospital | Kaohsiung City | Taiwan |
| China Medical University Hospital | Taichung | Taiwan |
| Chung Shan Medical University Hospital | Taichung | Taiwan |
| Taichung Veterans General Hospital | Taichung | Taiwan |
| National Cheng Kung University Hospital | Tainan | Taiwan |
| Cathay General Hospital | Taipei | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Tri-Service General Hospital | Taipei | Taiwan |
| Chang Gung Medical Foundation, LinKou Chang Gung Memorial Hospital | Taoyuan | Taiwan |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
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| ID | Term |
|---|---|
| C571216 | brodalumab |
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