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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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| Published in: | Rheumatology international 2014-11, Vol.34 (11), p.1519-1527 |
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| container_title | Rheumatology international |
| container_volume | 34 |
| creator | 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 |
| description | 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
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| doi_str_mv | 10.1007/s00296-014-2989-z |
| format | article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_1616073741</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>3470662421</sourcerecordid><originalsourceid>FETCH-LOGICAL-c394t-a741dd4b25e101a73656dc73b5a48d233bbacab352cd81f85d3faa13d3dd0cbf3</originalsourceid><addsrcrecordid>eNp1UctuEzEUtRCIhsIHsEGW2MZgj-eRLKuIlxSJTZHYjfy4k3Hlsae2p23y0XwDt0pBbNhc6_q8bB1C3gr-QXDefcycV9uWcVGzarvZstMzshK17Jho-c_nZMVFV7ENjgvyKucbjnvb8pfkoqrbTjRcrMivK5pUsHFyJ7BrauOiPTDtXcANATp7ZUBHZmIoKXoPlk6LL85AKJCoQaYzytOSHM44UEVDvANPzbHEEh-codfMH6d5jHgD6FncAQKr6bBkFwOdUyzgwprucbpwWFMX6G50ATKyTXF3QNMIy6RKdJaqVMbkist0VsXhIzK9d2VEX9QpC7eLwpQEeY4BDUqkE5QxlgQPCLwmLwblM7x5Oi_Jj8-frndf2f77l2-7qz0zclsXprpaWFvrqgHBhepk27TWdFI3qt7YSkqtlVFaNpWxGzFsGisHpYS00lpu9CAvyfuzL_7udoFc-pu4pICRvWixnU5iArLEmWVSzDnB0M_JTSode8H7x4b7c8M9Ntw_NtyfUPPuyXnRE9i_ij-VIqE6EzJC4QDpn-j_uv4GYNC5fA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1616073741</pqid></control><display><type>article</type><title>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</title><source>Springer Link</source><creator>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</creator><creatorcontrib>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</creatorcontrib><description><![CDATA[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
< 0.001). Similarly, ACR50 and ACR70 responses of Leining group were significantly higher than those of placebo group (40.30 vs. 22.73 %;
p
< 0.001 and 16.67 vs. 7.27 %;
p
< 0.05, respectively). DAS28-ESR in Leining group was significantly reduced compared to that in placebo group, with greater clinically meaningful (>1.2 unit) improvement (54.85 vs. 29.09 %,
p
< 0.05). Both the rates of remission (DAS28-ESR < 2.6) and low disease activity (DAS28-ESR < 3.2) were greater in the Leining group than those in the placebo group (12.42 vs. 2.73 %;
p
< 0.05 and 15.45 vs. 2.73 %;
p
< 0.05 respectively). The overall incidence of adverse events was similar in both Leining and placebo groups. No neutralizing antibodies were detected. Leining demonstrated clinically meaningful efficacy compared with placebo in Chinese patients with active RA despite MTX therapy. Administration of Leining in combination with MTX for 24 weeks was well tolerated.]]></description><identifier>ISSN: 0172-8172</identifier><identifier>EISSN: 1437-160X</identifier><identifier>DOI: 10.1007/s00296-014-2989-z</identifier><identifier>PMID: 24671501</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer Berlin Heidelberg</publisher><subject>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</subject><ispartof>Rheumatology international, 2014-11, Vol.34 (11), p.1519-1527</ispartof><rights>Springer-Verlag Berlin Heidelberg 2014</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c394t-a741dd4b25e101a73656dc73b5a48d233bbacab352cd81f85d3faa13d3dd0cbf3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27922,27923</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24671501$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Fan, Wei</creatorcontrib><creatorcontrib>Zhao, Dong-bao</creatorcontrib><creatorcontrib>Hu, Shao-Xian</creatorcontrib><creatorcontrib>Xu, Hu-ji</creatorcontrib><creatorcontrib>Zhang, Xiao</creatorcontrib><creatorcontrib>Zhang, Miu-jia</creatorcontrib><creatorcontrib>Chen, Zhi-wei</creatorcontrib><creatorcontrib>Zhang, Feng-xiao</creatorcontrib><creatorcontrib>Zhu, Ping</creatorcontrib><creatorcontrib>Li, Xin-fu</creatorcontrib><creatorcontrib>Bi, Li-qi</creatorcontrib><creatorcontrib>Zhou, Bin</creatorcontrib><creatorcontrib>Bao, Chun-de</creatorcontrib><title>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</title><title>Rheumatology international</title><addtitle>Rheumatol Int</addtitle><addtitle>Rheumatol Int</addtitle><description><![CDATA[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
< 0.001). Similarly, ACR50 and ACR70 responses of Leining group were significantly higher than those of placebo group (40.30 vs. 22.73 %;
p
< 0.001 and 16.67 vs. 7.27 %;
p
< 0.05, respectively). DAS28-ESR in Leining group was significantly reduced compared to that in placebo group, with greater clinically meaningful (>1.2 unit) improvement (54.85 vs. 29.09 %,
p
< 0.05). Both the rates of remission (DAS28-ESR < 2.6) and low disease activity (DAS28-ESR < 3.2) were greater in the Leining group than those in the placebo group (12.42 vs. 2.73 %;
p
< 0.05 and 15.45 vs. 2.73 %;
p
< 0.05 respectively). The overall incidence of adverse events was similar in both Leining and placebo groups. No neutralizing antibodies were detected. Leining demonstrated clinically meaningful efficacy compared with placebo in Chinese patients with active RA despite MTX therapy. Administration of Leining in combination with MTX for 24 weeks was well tolerated.]]></description><subject>Adult</subject><subject>Antirheumatic Agents - adverse effects</subject><subject>Antirheumatic Agents - therapeutic use</subject><subject>Arthritis, Rheumatoid - diagnosis</subject><subject>Arthritis, Rheumatoid - drug therapy</subject><subject>Arthritis, Rheumatoid - ethnology</subject><subject>Arthritis, Rheumatoid - immunology</subject><subject>Asian Continental Ancestry Group</subject><subject>Blood Sedimentation</subject><subject>China - epidemiology</subject><subject>Disability Evaluation</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Humans</subject><subject>Immunoconjugates - adverse effects</subject><subject>Immunoconjugates - therapeutic use</subject><subject>Immunosuppressive Agents - adverse effects</subject><subject>Immunosuppressive Agents - therapeutic use</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Methotrexate - adverse effects</subject><subject>Methotrexate - therapeutic use</subject><subject>Middle Aged</subject><subject>Original Article</subject><subject>Recombinant Fusion Proteins - adverse effects</subject><subject>Recombinant Fusion Proteins - therapeutic use</subject><subject>Remission Induction</subject><subject>Rheumatology</subject><subject>Severity of Illness Index</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>0172-8172</issn><issn>1437-160X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><recordid>eNp1UctuEzEUtRCIhsIHsEGW2MZgj-eRLKuIlxSJTZHYjfy4k3Hlsae2p23y0XwDt0pBbNhc6_q8bB1C3gr-QXDefcycV9uWcVGzarvZstMzshK17Jho-c_nZMVFV7ENjgvyKucbjnvb8pfkoqrbTjRcrMivK5pUsHFyJ7BrauOiPTDtXcANATp7ZUBHZmIoKXoPlk6LL85AKJCoQaYzytOSHM44UEVDvANPzbHEEh-codfMH6d5jHgD6FncAQKr6bBkFwOdUyzgwprucbpwWFMX6G50ATKyTXF3QNMIy6RKdJaqVMbkist0VsXhIzK9d2VEX9QpC7eLwpQEeY4BDUqkE5QxlgQPCLwmLwblM7x5Oi_Jj8-frndf2f77l2-7qz0zclsXprpaWFvrqgHBhepk27TWdFI3qt7YSkqtlVFaNpWxGzFsGisHpYS00lpu9CAvyfuzL_7udoFc-pu4pICRvWixnU5iArLEmWVSzDnB0M_JTSode8H7x4b7c8M9Ntw_NtyfUPPuyXnRE9i_ij-VIqE6EzJC4QDpn-j_uv4GYNC5fA</recordid><startdate>20141101</startdate><enddate>20141101</enddate><creator>Fan, Wei</creator><creator>Zhao, Dong-bao</creator><creator>Hu, Shao-Xian</creator><creator>Xu, Hu-ji</creator><creator>Zhang, Xiao</creator><creator>Zhang, Miu-jia</creator><creator>Chen, Zhi-wei</creator><creator>Zhang, Feng-xiao</creator><creator>Zhu, Ping</creator><creator>Li, Xin-fu</creator><creator>Bi, Li-qi</creator><creator>Zhou, Bin</creator><creator>Bao, Chun-de</creator><general>Springer Berlin Heidelberg</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope></search><sort><creationdate>20141101</creationdate><title>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</title><author>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</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c394t-a741dd4b25e101a73656dc73b5a48d233bbacab352cd81f85d3faa13d3dd0cbf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adult</topic><topic>Antirheumatic Agents - adverse effects</topic><topic>Antirheumatic Agents - therapeutic use</topic><topic>Arthritis, Rheumatoid - diagnosis</topic><topic>Arthritis, Rheumatoid - drug therapy</topic><topic>Arthritis, Rheumatoid - ethnology</topic><topic>Arthritis, Rheumatoid - immunology</topic><topic>Asian Continental Ancestry Group</topic><topic>Blood Sedimentation</topic><topic>China - epidemiology</topic><topic>Disability Evaluation</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Immunoconjugates - adverse effects</topic><topic>Immunoconjugates - therapeutic use</topic><topic>Immunosuppressive Agents - adverse effects</topic><topic>Immunosuppressive Agents - therapeutic use</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Methotrexate - adverse effects</topic><topic>Methotrexate - therapeutic use</topic><topic>Middle Aged</topic><topic>Original Article</topic><topic>Recombinant Fusion Proteins - adverse effects</topic><topic>Recombinant Fusion Proteins - therapeutic use</topic><topic>Remission Induction</topic><topic>Rheumatology</topic><topic>Severity of Illness Index</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Fan, Wei</creatorcontrib><creatorcontrib>Zhao, Dong-bao</creatorcontrib><creatorcontrib>Hu, Shao-Xian</creatorcontrib><creatorcontrib>Xu, Hu-ji</creatorcontrib><creatorcontrib>Zhang, Xiao</creatorcontrib><creatorcontrib>Zhang, Miu-jia</creatorcontrib><creatorcontrib>Chen, Zhi-wei</creatorcontrib><creatorcontrib>Zhang, Feng-xiao</creatorcontrib><creatorcontrib>Zhu, Ping</creatorcontrib><creatorcontrib>Li, Xin-fu</creatorcontrib><creatorcontrib>Bi, Li-qi</creatorcontrib><creatorcontrib>Zhou, Bin</creatorcontrib><creatorcontrib>Bao, Chun-de</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Complete (ProQuest Database)</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>PML(ProQuest Medical Library)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><jtitle>Rheumatology international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Fan, Wei</au><au>Zhao, Dong-bao</au><au>Hu, Shao-Xian</au><au>Xu, Hu-ji</au><au>Zhang, Xiao</au><au>Zhang, Miu-jia</au><au>Chen, Zhi-wei</au><au>Zhang, Feng-xiao</au><au>Zhu, Ping</au><au>Li, Xin-fu</au><au>Bi, Li-qi</au><au>Zhou, Bin</au><au>Bao, Chun-de</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>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</atitle><jtitle>Rheumatology international</jtitle><stitle>Rheumatol Int</stitle><addtitle>Rheumatol Int</addtitle><date>2014-11-01</date><risdate>2014</risdate><volume>34</volume><issue>11</issue><spage>1519</spage><epage>1527</epage><pages>1519-1527</pages><issn>0172-8172</issn><eissn>1437-160X</eissn><abstract><![CDATA[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
< 0.001). Similarly, ACR50 and ACR70 responses of Leining group were significantly higher than those of placebo group (40.30 vs. 22.73 %;
p
< 0.001 and 16.67 vs. 7.27 %;
p
< 0.05, respectively). DAS28-ESR in Leining group was significantly reduced compared to that in placebo group, with greater clinically meaningful (>1.2 unit) improvement (54.85 vs. 29.09 %,
p
< 0.05). Both the rates of remission (DAS28-ESR < 2.6) and low disease activity (DAS28-ESR < 3.2) were greater in the Leining group than those in the placebo group (12.42 vs. 2.73 %;
p
< 0.05 and 15.45 vs. 2.73 %;
p
< 0.05 respectively). The overall incidence of adverse events was similar in both Leining and placebo groups. No neutralizing antibodies were detected. Leining demonstrated clinically meaningful efficacy compared with placebo in Chinese patients with active RA despite MTX therapy. Administration of Leining in combination with MTX for 24 weeks was well tolerated.]]></abstract><cop>Berlin/Heidelberg</cop><pub>Springer Berlin Heidelberg</pub><pmid>24671501</pmid><doi>10.1007/s00296-014-2989-z</doi><tpages>9</tpages></addata></record> |
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| ispartof | Rheumatology international, 2014-11, Vol.34 (11), p.1519-1527 |
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| 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 |
| title | 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 |
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