A randomized, double-blind, and placebo-controlled multicenter clinical trial of a novel cytotoxic T-lymphocyte antigen-4 fusion protein, Leining, in Chinese active rheumatoid arthritis patients with an inadequate response to methotrexate

To assess the clinical efficacy as well as safety profiles of Leining, a novel cytotoxic T-lymphocyte antigen-4 fusion protein, versus placebo in the treatment of Chinese active rheumatoid arthritis (RA) patients with an inadequate clinical response to methotrexate (MTX). In this 24-week, randomized...

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Bibliographic Details
Published in:Rheumatology international 2014-11, Vol.34 (11), p.1519-1527
Main Authors: Fan, Wei, Zhao, Dong-bao, Hu, Shao-Xian, Xu, Hu-ji, Zhang, Xiao, Zhang, Miu-jia, Chen, Zhi-wei, Zhang, Feng-xiao, Zhu, Ping, Li, Xin-fu, Bi, Li-qi, Zhou, Bin, Bao, Chun-de
Format: Article
Language:English
Subjects:
Adult
Antirheumatic Agents - adverse effects
Antirheumatic Agents - therapeutic use
Arthritis, Rheumatoid - diagnosis
Arthritis, Rheumatoid - drug therapy
Arthritis, Rheumatoid - ethnology
Arthritis, Rheumatoid - immunology
Asian Continental Ancestry Group
Blood Sedimentation
China - epidemiology
Disability Evaluation
Double-Blind Method
Female
Humans
Immunoconjugates - adverse effects
Immunoconjugates - therapeutic use
Immunosuppressive Agents - adverse effects
Immunosuppressive Agents - therapeutic use
Male
Medicine
Medicine & Public Health
Methotrexate - adverse effects
Methotrexate - therapeutic use
Middle Aged
Original Article
Recombinant Fusion Proteins - adverse effects
Recombinant Fusion Proteins - therapeutic use
Remission Induction
Rheumatology
Severity of Illness Index
Time Factors
Treatment Outcome
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Summary:To assess the clinical efficacy as well as safety profiles of Leining, a novel cytotoxic T-lymphocyte antigen-4 fusion protein, versus placebo in the treatment of Chinese active rheumatoid arthritis (RA) patients with an inadequate clinical response to methotrexate (MTX). In this 24-week, randomized, double-blind, placebo-controlled multicenter study, a total of 440 Chinese patients with active RA with an inadequate response to MTX were randomly assigned to receive Leining (10 mg/kg) or placebo. Clinical response was assessed using the American College of Rheumatology 20 % improvement criteria ACR20, ACR50, and ACR70, with ACR20 as the primary major endpoints. Disease activity scores in 28 joints with erythrocyte sedimentation rate assessment (DAS28-ESR) were used to evaluate disease activity. After 24 weeks of treatment, significantly more patients in Leining group achieved ACR20 response than those in placebo group (70.61 vs. 46.36 %; p  
ISSN:0172-8172
1437-160X
DOI:10.1007/s00296-014-2989-z