Effects of BI 655064, an antagonistic anti-CD40 antibody, on clinical and biomarker variables in patients with active rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase IIa study

Visvanathan Sudha; Daniluk Stefan; Ptaszynski Rafal; Mueller-Ladner Ulf; Ramanujam Meera; Rosenstock Bernd; Eleftheraki Anastasia G.; Vinisko Richard; Petrikova Alena; Kellner Herbert; Dokoupilova Eva; Kwiatkowska Brygida; Alten Rieke; Schwabe Christian; Baum Patrick; Joseph David; Fine Jay S.; Padula Steven J.; Steffgen Juergen

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Effects of BI 655064, an antagonistic anti-CD40 antibody, on clinical and biomarker variables in patients with active rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase IIa study

机译：抗拮抗抗CD40抗体，抗拮抗抗CD40抗体，在活性类风湿性关节炎患者中的临床和生物标志物变量：随机，双盲，安慰剂控制，IIA研究

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Objective To evaluate the safety, efficacy and therapeutic mechanism of BI 655064, an antagonistic anti-CD40 monoclonal antibody, in patients with rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX-IR).

机译：目的探讨BI 655064，拮抗抗CD40单克隆抗体，类风湿性关节炎（RA）患者的安全性，疗效和治疗机制及对甲氨蝶呤（MTX-IR）的不足反应。

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《Annals of the Rheumatic Diseases: A Journal of Clinical Rheumatology and Connective Tissue Research》 |2019年第6期|共7页
作者
Visvanathan Sudha; Daniluk Stefan; Ptaszynski Rafal; Mueller-Ladner Ulf; Ramanujam Meera; Rosenstock Bernd; Eleftheraki Anastasia G.; Vinisko Richard; Petrikova Alena; Kellner Herbert; Dokoupilova Eva; Kwiatkowska Brygida; Alten Rieke; Schwabe Christian; Baum Patrick; Joseph David; Fine Jay S.; Padula Steven J.; Steffgen Juergen;
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作者单位

Boehringer Ingelheim Pharmaceut Inc 90 E Ridge POB 368 Ridgefield CT 06877 USA;

ClinicMed Badurski &

Partners Bialystok Poland;

Justus Liebig Univ Giessen Bad Nauheim Germany;

Boehringer Ingelheim Pharmaceut Inc 90 E Ridge POB 368 Ridgefield CT 06877 USA;

Boehringer Ingelheim Pharma GmbH &

Co KG Biberach Germany;

Boehringer Ingelheim Pharma GmbH &

Co KG Biberach Germany;

Boehringer Ingelheim Pharmaceut Inc 90 E Ridge POB 368 Ridgefield CT 06877 USA;

CTCtr MaVe Olomouc Czech Republic;

Ctr Inflammatory Joint Dis Munich Germany;

Med Plus Sro Uherske Hradiste Czech Republic;

Prof Eleonora Reicher Mem Natl Inst Geriatr Rheum Warsaw Poland;

Schlosspk Klin Berlin Germany;

Auckland Clin Studies Auckland New Zealand;

Boehringer Ingelheim Pharma GmbH &

Co KG Biberach Germany;

Boehringer Ingelheim Pharmaceut Inc 90 E Ridge POB 368 Ridgefield CT 06877 USA;

Boehringer Ingelheim Pharmaceut Inc 90 E Ridge POB 368 Ridgefield CT 06877 USA;

Boehringer Ingelheim Int GmbH Ingelheim Germany;

Boehringer Ingelheim Pharma GmbH &

Co KG Biberach Germany;

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正文语种 eng
中图分类免疫性疾病;
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1. Effects of BI 655064, an antagonistic anti-CD40 antibody, on clinical and biomarker variables in patients with active rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase IIa study [J] . Visvanathan Sudha, Daniluk Stefan, Ptaszynski Rafal, Annals of the Rheumatic Diseases: A Journal of Clinical Rheumatology and Connective Tissue Research . 2019,第6期

机译：抗拮抗抗CD40抗体，抗拮抗抗CD40抗体，在活性类风湿性关节炎患者中的临床和生物标志物变量：随机，双盲，安慰剂控制，IIA研究
2. MOR103, a human monoclonal antibody to granulocyte-macrophage colony-stimulating factor, in the treatment of patients with moderate rheumatoid arthritis: results of a phase Ib/IIa randomised, double-blind, placebo-controlled, dose-escalation trial [J] . Behrens Frank, Tak Paul P., Ostergaard Mikkel, Annals of the Rheumatic Diseases: A Journal of Clinical Rheumatology and Connective Tissue Research . 2015,第6期

机译：MOR103，一种针对粒细胞巨噬细胞集落刺激因子的人单克隆抗体，在中度类风湿关节炎患者的治疗中：Ib / IIa期随机，双盲，安慰剂对照，剂量递增试验的结果
3. Effects of the anti-RANKL antibody denosumab on joint structural damage in patients with rheumatoid arthritis treated with conventional synthetic disease-modifying antirheumatic drugs (DESIRABLE study): a randomised, double-blind, placebo-controlled phase 3 trial [J] . Takeuchi Tsutomu, Tanaka Yoshiya, Soen Satoshi, Annals of the Rheumatic Diseases: A Journal of Clinical Rheumatology and Connective Tissue Research . 2019,第7期

机译：抗rankl抗体Denosumab对常规综合性疾病修饰抗腹炎治疗类风湿性关节炎患者联合结构损伤的影响（理想的研究）：随机，双盲，安慰剂控制第3期试验
4. Clinical studies of immunomodulatory activities of Yunzhi -Danshen in breast cancer and nasopharyngeal carcinoma patients, and Lingzhi-San Miao San in rheumatoid arthritis patients. [D] . Bao, Yixi. 2005

机译：云芝丹参对乳腺癌和鼻咽癌患者及类风湿关节炎灵芝三妙散的免疫调节活性的临床研究。
5. Effects of BI 655064 an antagonistic anti-CD40 antibody on clinical and biomarker variables in patients with active rheumatoid arthritis: a randomised double-blind placebo-controlled phase IIa study [O] . Sudha Visvanathan, Stefan Daniluk, Rafał Ptaszyński, -1

机译：拮抗性抗CD40抗体BI 655064对活动性类风湿关节炎患者的临床和生物标志物变量的影响：一项随机双盲安慰剂对照的IIa期研究
6. Effects of BI 655064, an antagonistic anti-CD40 antibody, on clinical and biomarker variables in patients with active rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase IIa study [O] . Sudha Visvanathan, Stefan Daniluk, Rafał Ptaszyński, 2019

机译：抗拮抗抗CD40抗体，患者对患者的临床和生物标志物变量的影响：随机，双盲，安慰剂控制，相IIA研究

Effects of BI 655064, an antagonistic anti-CD40 antibody, on clinical and biomarker variables in patients with active rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase IIa study

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