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address.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},318137,1790361540,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":44,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145},1374404730887,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","UCB 17 December 2018  \nClinical Study Protocol Certolizumab Pegol AS0006  \nPROTOCOL AS0006 (C-AXSPAND) AMENDMENT 5  \nPHASE 3, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE EFFICACY AND SAFETY OF CERTOLIZUMABPEGOL IN SUBJECTS WITH ACTIVE AXIAL SPONDYLOARTHRITIS (AXSPA) WITHOUT X-RAY EVIDENCE OF ANKYLOSING SPONDYLITIS (AS) AND OBJECTIVE SIGNS OF INFLAMMATION  \nPHASE 3  \nEudraCT Number: 2015-001894~~-~~41  \nIND Number: 9,869  \nUCB BIOSCIENCES GmbH  \nAlfred-Nobel-Strasse 10  \n40789 Monheim  \nGERMANY  \n\n| Protocol/Amendment number | Date | Type of\u003Cbr>amendment |\n| --- | --- | --- |\n| Final Protocol | 01 Jun 2015 | Not applicable |\n| Protocol Amendment 0.1 (Taiwan) | 02 Sep 2015 | Substantial |\n| Protocol Amendment 1 | 15 Dec 2015 | Substantial |\n| Protocol Amendment 1.1 (Taiwan) | 12 Jan 2016 | Substantial |\n| Protocol Amendment 2 | 14 Mar 2016 | Substantial |\n| Protocol Amendment 2. 1 (Taiwan) | 22 Apr 2016 | Substantial |\n| Protocol Amendment 3 | 13 Feb 2017 | Substantial |\n| Protocol Amendment 3.1 (Taiwan) | 24 Mar 2017 | Substantial |\n| Protocol Amendment 3.2 (Australia) | 28 Apr 2017 | Substantial |\n| Protocol Amendment 4 | 19 Dec 2017 | Substantial |\n| Protocol Amendment 4.1 (Taiwan) | 08 Jan 2018 | Substantial |\n| Protocol Amendment 4.2 (Australia) | 08 Jan 2018 | Substantial |\n| Protocol Amendment 5 | 17 Dec 2018 | Substantial |\n\nConfidential Material  \nConfidential  \nThis document is the property of UCB and may not – in full or in part – be passed on, reproduced, published, or otherwise used without the express permission of UCB.  \nREREDACTED COPY This document        authorization application and any extensions or variations thereof.  \nConfidential Page 1 of 255  \nUCB 17 December 2018  \nClinical Study Protocol Certolizumab Pegol AS0006  \nSTUDY CONTACT INFORMATION  \nSponsor  \nUCB BIOSCIENCES GmbH Alfred-Nobel-Strasse 10  \n40789 Monheim GERMANY  \nSponsor Study Physician  \n\n| Name: |  , MD |\n| --- | --- |\n| Address: | Alfred-Nobel-Str 10\u003Cbr>40789 Monheim\u003Cbr>Germany |\n| Phone: |  |\n| Fax: |  |\n\nClinical Project Manager  \n\n| Name: |  , PhD |\n| --- | --- |\n| Address: | Alfred-Nobel~~-~~Str 10\u003Cbr>40789 Monheim\u003Cbr>Germany |\n| Phone: | |\n| Fax: | |\n\nClinical Trial Biostatistician  \n\n| Name: |  , PhD |\n| --- | --- |\n| Address: | Alfred-Nobel-Str 10\u003Cbr>40789 Monheim\u003Cbr>Germany |\n| Phone: |  |\n| Fax: |  |\n\nR ED  This document cannotan be usedu d to  any marketing thizationn applicationpl tio and anyy extensionse ten or variations thereof.  \nConfidential Page 2 of 255  \nUCB 17 December 2018  \nClinical Study Protocol Certolizumab Pegol AS0006  \nClinical Monitoring Contract Research Organization  \n\n| Name: | PRA Health Sciences |\n| --- | --- |\n| Address: | 500 South Oak Way,\u003Cbr>Green Park,\u003Cbr>Reading,\u003Cbr>Berkshire RG2 6AD,\u003Cbr>UK |\n| Phone: | +44 (118) 918 1000 |\n| Fax: | +44 (118) 918 1001 |\n\nREDACTED COPY This document cannot be used to support any marketing authorization application and any ex  variationsv thereof.  \nConfidential Page 3 of 255  \nUCB 17 December 2018  \nClinical Study Protocol Certolizumab Pegol AS0006  \nSERIOUS ADVERSE EVENT REPORTING  \n\n| Serious Adverse Event reporting (24h) and safety related issues |  |\n| --- | --- |\n| Fax | Europe and Rest ofthe World: +32 2 386 24 21\u003Cbr>USA and Canada: +1 800 880 6949 or +1 866 890 3175 |\n| E-Mail | [DS_ICT@ucb.com](DS_ICT@ucb.com) |\n\nREDACTED COPY This document cannot be used to support any marketing authorization application and any extensions  variationsva thereof.  \nConfidential Page 4 of 255  \nUCB 17 December 2018  \nClinical Study Protocol Certolizumab Pegol AS0006  \nTABLE OF CONTENTS  \nLIST OF ABBREVIATIONS.................................................................................................. 11  \n1 SUMMARY ..................................................................................................................... 16  \n2 INTRODUCTION ............................................................................................","cbCaijoqRgfXFmQh","https://ap.wps.com/l/cbCaijoqRgfXFmQh","pdf",9785526,256,"English","# List of abbreviations\n# Summary\n# Introduction\n## Natural history of axial spondyloarthritis\n## Burden of disease in axSpA\n## Diagnosing axSpA in clinical practice\n## Current management of axial spondyloarthritis\n## Rationale\n# Study objectives\n## Primary objective\n## Secondary objectives\n## Other objectives\n# Study variables\n## Efficacy variables\n### Primary efficacy variable\n### Secondary efficacy variables\n### Other efficacy variables\n## Pharmacokinetic, exploratory biomarker, and pharmacogenomic variables\n### Primary pharmacokinetic variables","[{\"question\":\"What study population is targeted in Protocol AS0006 (C-AXSPAND)?\",\"answer\":\"The study enrolls subjects with active axial spondyloarthritis (axSpA) without x-ray evidence of ankylosing spondylitis and with objective signs of inflammation.\"},{\"question\":\"What is the study design for evaluating certolizumab pegol?\",\"answer\":\"It is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study assessing efficacy and safety.\"},{\"question\":\"Who should be contacted for serious adverse event reporting?\",\"answer\":\"The document provides serious adverse event reporting contact information, including Europe and Rest of World phone numbers, USA and Canada phone numbers, and a dedicated email address.\"}]","Clinical Study Protocol Certolizumab Pegol AS0006 (C-AXSPAND) - Amendment 5 - Protocol/Amendment summary | PDF",1789939594,645]