Fifty-two-week Results from a Phase 3, Randomized, Double-blind, Active-controlled Clinical Trial to Compare BAT1806/BIIB800, a Proposed Tocilizumab Biosimilar, with a Tocilizumab Reference Product in Subjects with Moderate to Severe RA with an Inadequate Response to Methotrexate

被引：0

作者：

Leng, Xiaomei ^{[1
]}

Leszczynski, Piotr ^{[2
]}

Jeka, Slawomir ^{[3
]}

Liu, Shengyun ^{[4
]}

Liu, Huaxiang ^{[5
]}

Miakisz, Malgorzata ^{[6
]}

Gu, Jieruo ^{[7
]}

Kilasonia, Lali ^{[8
]}

Stanislavchuk, Mykola ^{[9
]}

Yang, Xiaolei ^{[10
]}

Zhou, Yinbo ^{[10
]}

Dong, Qingfeng ^{[10
]}

Mitroiu, Marian ^{[11
]}

Addison, Janet ^{[12
]}

Zeng, Xiaofeng ^{[13
]}

机构：

[1] Peking Union Med Coll Hosp, Dept Rheumatol & Clin Immunol, Beijing, Peoples R China

[2] Poznan Univ Med Sci, Dept Rheumatol Rehabil & Internal Med, Poznan, Poland

[3] Univ Hosp 2 Bydgoszcz, Clin & Dept Rheumatol & Connect Tissue Dis, Coll Med UMK, Bydgoszcz, Poland

[4] Zhengzhou Univ, Affiliated Hosp 1, Dept Rheumatol & Immunol, Zhengzhou, Peoples R China

[5] Shandong Univ, Dept Rheumatol, Qilu Hosp, Jinan, Peoples R China

[6] Twoja Przychodnia Ctr Medyczne, Internal Med & Rheumatol, Nowa S ol, Poland

[7] Sun Yat Sen Univ, Affiliated Hosp 3, Dept Rheumatol, Guangzhou, Peoples R China

[8] Tbilisi Heart & Vasc Clin Ltd, Rheumatol, Tbilisi, Georgia

[9] Natl Pirogov Mem Med Univ, Internal Med, Vinnytsia, Ukraine

[10] Biothera Solut Ltd, Res & Dev, Guangzhou, Peoples R China

[11] Biogen Int GmbH, Evidence Generat Biosimilars, Baar, Switzerland

[12] Biogen Idec Ltd, Maidenhead, Berks, England

[13] Chinese Acad Med Sci, Peking Union Med Coll Hosp, Dept Rheumatol, Natl Clin Res Ctr Dermatol & Immunol Dis NCRC DID, Beijing, Peoples R China

来源：

ARTHRITIS & RHEUMATOLOGY | 2022年 / 74卷

关键词：

D O I：

暂无

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

0917

引用

页码：1813 / 1816

页数：4

共 15 条

[1] A PHASE III, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED CLINICAL TRIAL TO COMPARE BAT1806/BIIB800, A PROPOSED TOCILIZUMAB BIOSIMILAR, WITH TOCILIZUMAB REFERENCE PRODUCT IN SUBJECTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE THERAPY
Leng, X.
Leszczynski, P.
Jeka, S.
Liu, S.
Liu, H.
Miakisz, M.
Gu, J.
Kilasonia, L.
Stanislavchuk, M.
Yang, X.
Zhou, Y.
Dong, Q.
Mitroiu, M.
Addison, J.
Zeng, X.
ANNALS OF THE RHEUMATIC DISEASES, 2022, 81 : 388 - 388
[2] A phase 3, randomized, double-blind, active-controlled clinical trial to compare BAT1806/BIIB800, a tocilizumab biosimilar, with tocilizumab reference product in participants with moderate-to-severe rheumatoid arthritis with inadequate response to methotrexate: treatment period 2 analysis (week 24 to week 48)
Leng, Xiaomei
Leszczynski, Piotr
Jeka, Slawomir
Liu, Shengyun
Liu, Huaxiang
Miakisz, Malgorzata
Gu, Jieruo
Kilasonia, Lali
Stanislavchuk, Mykola
Yang, Xiaolei
Zhou, Yinbo
Dong, Qingfeng
Mitroiu, Marian
Addison, Janet
Rezk, Mourad F.
Zeng, Xiaofeng
ARTHRITIS RESEARCH & THERAPY, 2024, 26 (01)
[3] Comparing tocilizumab biosimilar BAT1806/BIIB800 with reference tocilizumab in patients with moderate-to-severe rheumatoid arthritis with an inadequate response to methotrexate: a phase 3, randomised, multicentre, double-blind, active-controlled clinical trial
Leng, Xiaomei
Leszczynski, Piotr
Jeka, Slawomir
Liu, Sheng-Yun
Liu, Huaxiang
Miakisz, Malgorzata
Gu, Jieruo
Kilasonia, Lali
Stanislavchuk, Mykola
Yang, Xiaolei
Zhou, Yinbo
Dong, Qingfeng
Rezk, Mourad
Mitroiu, Marian
Addison, Janet
Zeng, Xiaofeng
LANCET RHEUMATOLOGY, 2024, 6 (01): : e40 - e50
[4] Comparing tocilizumab biosimilar BAT1806/BIIB800 with reference tocilizumab in patients with moderate-to-severe rheumatoid arthritis with an inadequate response to methotrexate: a phase 3, randomised, multicentre, double-blind, active-controlled clinical trial (JAN, 10.1016/S2665-9913(23)00237-0, 2024)
Leng, X.
Leszczynski, P.
Jeka, S.
LANCET RHEUMATOLOGY, 2024, 6 (03): : e140 - e140
[5] A multicenter, double-blind, randomized, parallel-group, active-controlled, phase 3 clinical trial to compare the effectiveness and safety of two botulinum toxin type A formulations for improving moderate to severe glabellar wrinkles in Asians
Choi, Sun Young
Koh, Young Gue
Lee, Yang Won
Son, Hyung Seok
Yoon, Yi Na
Kim, Gyeonghoon
Won, Chonghyun
Cho, Hyesoo
Son, Joo-Sun
Kim, Eun-Kyoung
Kim, Beom Joon
JOURNAL OF DERMATOLOGICAL TREATMENT, 2024, 35 (01)
[6] Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial
Jamshidi, Ahmadreza
Vojdanian, Mahdi
Soroush, Mohsen
Akbarian, Mahmoud
Aghaei, Mehrdad
Hajiabbasi, Asghar
Mirfeizi, Zahra
Khabbazi, Alireza
Alishiri, Gholamhosein
Haghighi, Anousheh
Salimzadeh, Ahmad
Karimzadeh, Hadi
Shirani, Fatemeh
Fard, Mohammad Reza Hatef
Nazarinia, MohammadAli
Soroosh, Soosan
Anjidani, Nassim
Gharibdoost, Farhad
ARTHRITIS RESEARCH & THERAPY, 2022, 24 (01)
[7] Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial
Ahmadreza Jamshidi
Mahdi Vojdanian
Mohsen Soroush
Mahmoud Akbarian
Mehrdad Aghaei
Asghar Hajiabbasi
Zahra Mirfeizi
Alireza Khabbazi
Gholamhosein Alishiri
Anousheh Haghighi
Ahmad Salimzadeh
Hadi Karimzadeh
Fatemeh Shirani
Mohammad Reza Hatef Fard
MohammadAli Nazarinia
Soosan Soroosh
Nassim Anjidani
Farhad Gharibdoost
Arthritis Research & Therapy, 24
[8] A Phase III, Randomized, Double-Blind Clinical Study Comparing SB4, an Etanercept Biosimilar, with Etanercept Reference Product (Enbrel®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (52-week Results)
Vencovsky, Jiri
Sylwestrzak, Anna
Leszczynski, Piotr
Porawska, Wieslawa
Baranauskaite, Asta
Tseluyko, Vira
Zhdan, Vyacheslav
Stasiuk, Barbara
Milasiene, Roma
Barrera Rodriguez, Aaron Alejandro
Cheong, Soo Yeon
Ghil, Jeehoon
Emery, Paul
ARTHRITIS & RHEUMATOLOGY, 2015, 67
[9] A Phase III, Randomized, Double-Blind Clinical Study Comparing SB5, an Adalimumab Biosimilar, with Adalimumab Reference Product (Humira®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (24-week Results)
Weinblatt, Michael E.
Baranauskaite, Asta
Niebrzydowski, Jaroslaw
Dokoupilova, Eva
Zielinska, Agnieszka
Sitek-Ziolkowska, Karina
Jaworski, Janusz
Racewicz, Artur
Pileckyte, Margarita
Jedrychowicz-Rosiak, Krystyna
Zhdan, Vyacheslav
Cheong, Soo Yeon
Ghil, Jeehoon
ARTHRITIS & RHEUMATOLOGY, 2015, 67
[10] A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis
Ahmadreza Jamshidi
Farhad Gharibdoost
Mahdi Vojdanian
Soosan G. Soroosh
Mohsen Soroush
Arman Ahmadzadeh
Mohammad Ali Nazarinia
Mohammad Mousavi
Hadi Karimzadeh
Mohammad Reza Shakibi
Zahra Rezaieyazdi
Maryam Sahebari
Asghar Hajiabbasi
Ali Asghar Ebrahimi
Najmeh Mahjourian
Amin Mohammadinejad Rashti
Arthritis Research & Therapy, 19

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