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<meta name="ncbi_db" content="books" /><meta name="ncbi_pdid" content="book-toc" /><meta name="ncbi_acc" content="NBK499478" /><meta name="ncbi_domain" content="ukeme0502" /><meta name="ncbi_report" content="record" /><meta name="ncbi_type" content="fulltext" /><meta name="ncbi_objectid" content="" /><meta name="ncbi_pcid" content="/NBK499478/" /><meta name="ncbi_pagename" content="Rituximab for the treatment of fatigue in primary biliary cholangitis (formerly primary biliary cirrhosis): a randomised controlled trial - NCBI Bookshelf" /><meta name="ncbi_bookparttype" content="toc" /><meta name="ncbi_app" content="bookshelf" />
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<meta name="robots" content="INDEX,FOLLOW,NOARCHIVE,NOIMAGEINDEX" /><meta name="author" content="Amardeep Khanna, Laura Jopson, Denise Howel, Andrew Bryant, Andrew Blamire, Julia L Newton, Jennifer Wilkinson, Alison J Steel, Jennifer Bainbridge, Renae Stefanetti, Sophie Cassidy, David Houghton, David E Jones" /><meta name="citation_title" content="Rituximab for the treatment of fatigue in primary biliary cholangitis (formerly primary biliary cirrhosis): a randomised controlled trial" /><meta name="citation_publisher" content="NIHR Journals Library" /><meta name="citation_date" content="2018/04" /><meta name="citation_author" content="Amardeep Khanna" /><meta name="citation_author" content="Laura Jopson" /><meta name="citation_author" content="Denise Howel" /><meta name="citation_author" content="Andrew Bryant" /><meta name="citation_author" content="Andrew Blamire" /><meta name="citation_author" content="Julia L Newton" /><meta name="citation_author" content="Jennifer Wilkinson" /><meta name="citation_author" content="Alison J Steel" /><meta name="citation_author" content="Jennifer Bainbridge" /><meta name="citation_author" content="Renae Stefanetti" /><meta name="citation_author" content="Sophie Cassidy" /><meta name="citation_author" content="David Houghton" /><meta name="citation_author" content="David E Jones" /><meta name="citation_pmid" content="29733563" /><meta name="citation_doi" content="10.3310/eme05020" /><meta name="citation_fulltext_html_url" content="https://www.ncbi.nlm.nih.gov/books/NBK499478/" /><meta name="citation_keywords" content="PRIMARY BILIARY CIRRHOSIS" /><meta name="citation_keywords" content="PRIMARY BILIARY CHOLANGITIS" /><meta name="citation_keywords" content="RITUXIMAB" /><meta name="citation_keywords" content="FATIGUE" /><link rel="schema.DC" href="http://purl.org/DC/elements/1.0/" /><meta name="DC.Title" content="Rituximab for the treatment of fatigue in primary biliary cholangitis (formerly primary biliary cirrhosis): a randomised controlled trial" /><meta name="DC.Type" content="Text" /><meta name="DC.Publisher" content="NIHR Journals Library" /><meta name="DC.Contributor" content="Amardeep Khanna" /><meta name="DC.Contributor" content="Laura Jopson" /><meta name="DC.Contributor" content="Denise Howel" /><meta name="DC.Contributor" content="Andrew Bryant" /><meta name="DC.Contributor" content="Andrew Blamire" /><meta name="DC.Contributor" content="Julia L Newton" /><meta name="DC.Contributor" content="Jennifer Wilkinson" /><meta name="DC.Contributor" content="Alison J Steel" /><meta name="DC.Contributor" content="Jennifer Bainbridge" /><meta name="DC.Contributor" content="Renae Stefanetti" /><meta name="DC.Contributor" content="Sophie Cassidy" /><meta name="DC.Contributor" content="David Houghton" /><meta name="DC.Contributor" content="David E Jones" /><meta name="DC.Date" content="2018/04" /><meta name="DC.Identifier" content="https://www.ncbi.nlm.nih.gov/books/NBK499478/" /><meta name="description" 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<div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/Book"><div class="meta-content fm-sec"><div class="iconblock whole_rhythm clearfix no_top_margin"><a href="http://www.journalslibrary.nihr.ac.uk/eme" title="NIHR Journals Library" class="img_link icnblk_img" ref="pagearea=logo&targetsite=external&targetcat=link&targettype=publisher"><img class="source-thumb" src="/corehtml/pmc/pmcgifs/bookshelf/thumbs/th-ukeme0502-lrg.png" alt="Cover of Rituximab for the treatment of fatigue in primary biliary cholangitis (formerly primary biliary cirrhosis): a randomised controlled trial" /></a><div class="icnblk_cntnt"><h1 id="_NBK499478_"><span itemprop="name">Rituximab for the treatment of fatigue in primary biliary cholangitis (formerly primary biliary cirrhosis): a randomised controlled trial</span></h1><p><i>Efficacy and Mechanism Evaluation, No. 5.2</i></p><p class="contrib-group"><span itemprop="author">Amardeep Khanna</span>, <span itemprop="author">Laura Jopson</span>, <span itemprop="author">Denise Howel</span>, <span itemprop="author">Andrew Bryant</span>, <span itemprop="author">Andrew Blamire</span>, <span itemprop="author">Julia L Newton</span>, <span itemprop="author">Jennifer Wilkinson</span>, <span itemprop="author">Alison J Steel</span>, <span itemprop="author">Jennifer Bainbridge</span>, <span itemprop="author">Renae Stefanetti</span>, <span itemprop="author">Sophie Cassidy</span>, <span itemprop="author">David Houghton</span>, and <span itemprop="author">David E Jones</span>.</p><a data-jig="ncbitoggler" href="#__NBK499478_ai__" style="border:0;text-decoration:none">Author Information and Affiliations</a><div style="display:none" class="ui-widget" id="__NBK499478_ai__"><p class="contrib-group"><h4>Authors</h4><span itemprop="author">Amardeep Khanna</span>,<sup>1,2</sup><sup>,<a href="#an2" class="bk_pop">†</a></sup> <span itemprop="author">Laura Jopson</span>,<sup>1,2</sup><sup>,<a href="#an2" class="bk_pop">†</a></sup> <span itemprop="author">Denise Howel</span>,<sup>3</sup> <span itemprop="author">Andrew Bryant</span>,<sup>3</sup> <span itemprop="author">Andrew Blamire</span>,<sup>2</sup> <span itemprop="author">Julia L Newton</span>,<sup>2</sup> <span itemprop="author">Jennifer Wilkinson</span>,<sup>4</sup> <span itemprop="author">Alison J Steel</span>,<sup>4</sup> <span itemprop="author">Jennifer Bainbridge</span>,<sup>2</sup> <span itemprop="author">Renae Stefanetti</span>,<sup>5</sup> <span itemprop="author">Sophie Cassidy</span>,<sup>5</sup> <span itemprop="author">David Houghton</span>,<sup>5</sup> and <span itemprop="author">David E Jones</span><sup>1,2</sup><sup>,*</sup>.</p><h4>Affiliations</h4><div class="affiliation"><sup>1</sup> Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK</div><div class="affiliation"><sup>2</sup> Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, UK</div><div class="affiliation"><sup>3</sup> Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK</div><div class="affiliation"><sup>4</sup> Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK</div><div class="affiliation"><sup>5</sup> Institute of Neuroscience, Newcastle University, Newcastle upon Tyne, UK</div><div class="affiliation"><sup>*</sup> Corresponding author<span class="before-email-separator">; </span><span class="email-label">Email: </span><a href="mailto:dev@null" data-email="ku.ca.lcn@senoj.j.e.d" class="oemail">ku.ca.lcn@senoj.j.e.d</a></div></div><div class="half_rhythm">Southampton (UK): <a href="http://www.journalslibrary.nihr.ac.uk/eme" ref="pagearea=meta&targetsite=external&targetcat=link&targettype=publisher"><span itemprop="publisher">NIHR Journals Library</span></a>; <span itemprop="datePublished">2018 Apr</span>.</div><div class="half_rhythm"><ul class="inline_list"><li><span class="label"><a data-jig="ncbidialog" href="#_ncbi_dlg_cpyrght_NBK499478" data-jigconfig="modal:true">Copyright and
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Permissions</a></span></li></ul></div><div id="_ncbi_dlg_cpyrght_NBK499478" style="display:none" title="Copyright and Permissions"><div><div>Copyright © Queen’s Printer and Controller of HMSO 2018. This work was produced by Khanna et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.</div><div class="half_rhythm"></div></div></div><div class="bk_noprnt"><form method="get" action="/books/n/ukeme0502/" id="bk_srch"><div class="bk_search"><label for="bk_term" class="offscreen_noflow">Search term</label><input type="text" title="Search this book" id="bk_term" name="term" value="" data-jig="ncbiclearbutton" /> <input type="submit" class="jig-ncbibutton" value="Search this book" submit="false" style="padding: 0.1em 0.4em;" /></div></form></div></div></div></div><div class="body-content whole_rhythm" itemprop="text"><div itemprop="description"><h2>Headline</h2><p>There was no difference in fatigue score in primary biliary cholangitis between rituximab and a placebo at 3 months</p></div><div itemprop="description"><h2>Abstract</h2><div id="abs1-1"><h4 class="inline">Background:</h4><p>Primary biliary cirrhosis (PBC) is an autoimmune liver disease, and 50% of patients with this disease experience fatigue. This is a debilitating symptom affecting quality of life and resulting in social isolation, which is highlighted by patients as a research priority. PBC is characterised immunologically by the presence of high-titre autoantibodies that are directed at the pyruvate dehydrogenase complex (PDC) and are highly effective at blocking its energy generation function. We hypothesised that if anti-PDC antibodies were a driver of fatigue through bioenergetic dysfunction, then the B-cell-targeting biological agent rituximab (MabThera<sup>®</sup>, Roche Products Ltd, Welwyn Garden City, UK) might be a therapeutic option.</p></div><div id="abs1-2"><h4 class="inline">Objective:</h4><p>To assess whether or not rituximab safely improved moderate or severe fatigue in PBC patients.</p></div><div id="abs1-3"><h4 class="inline">Design:</h4><p>A Phase II, double-blind, randomised controlled trial comparing rituximab with placebo in fatigued PBC patients. Randomisation was conducted using a web-based system. Participants received two infusions on days 1 and 15 and were followed up at 3, 6, 9 and 12 months.</p></div><div id="abs1-4"><h4 class="inline">Setting:</h4><p>A single-centre UK study in Newcastle upon Tyne Hospitals NHS Foundation Trust.</p></div><div id="abs1-5"><h4 class="inline">Participants:</h4><p>Seventy-one participants aged ≥ 18 years with PBC and moderate or severe fatigue (score of > 33 on the PBC-40 fatigue domain) were screened. The PBC-40 questionnaire is a fully validated disease-specific health-related quality-of-life measure for use in patients with PBC. Fatigue, with a maximum score of 55, is one of its six domains. Fifty-seven participants were randomised to the trial, 55 of whom reached the primary end-point assessment.</p></div><div id="abs1-6"><h4 class="inline">Intervention:</h4><p>Participants were randomised in a 1 : 1 ratio to receive either rituximab (1000 mg) or a saline intravenous infusion (placebo) on days 1 and 15. The infusions were delivered in a double-blind manner using the same protocol.</p></div><div id="abs1-7"><h4 class="inline">Main outcome measures:</h4><p>The primary outcome measure was the PBC-40 fatigue domain at 3 months, assessed on an intention-to-treat basis. Secondary outcome measures included markers of bioenergetics function (anaerobic threshold and post-exercise muscle pH assessed using magnetic resonance imaging) and physical activity levels. Impact on biochemical markers of liver disease severity was assessed as an experimental outcome.</p></div><div id="abs1-8"><h4 class="inline">Results:</h4><p>Rituximab therapy was safe, with no serious adverse events linked to the drug. There was no statistically significant difference in fatigue score at 3 months between the rituximab and placebo arms [adjusted mean difference –0.9, 95% confidence interval (CI) –4.6 to 3.1]. However, improvement in fatigue was observed in both arms {mean score decreasing from 41.2 [standard deviation (SD) 5.5] to 36.2 (SD 8.4) in the rituximab arm and from 43.0 (SD 5.9) to 38.1 (SD 8.7) in the placebo arm}. There was little difference in any of the secondary outcomes between arms. However, anaerobic threshold improved significantly in the rituximab arm (adjusted mean difference at 3 months 1.41, 95% CI 0.03 to 2.80). No change in muscle bioenergetics characteristics was seen. A suggestive improvement in liver biochemistry was observed.</p></div><div id="abs1-9"><h4 class="inline">Limitations:</h4><p>Recruitment was lower than the original target, leading to a reduction in study power. A clinically significant placebo effect on PBC-40 fatigue scores was seen.</p></div><div id="abs1-10"><h4 class="inline">Conclusions:</h4><p>Rituximab is ineffective for the treatment of fatigue in unselected PBC patients despite metabolic modulation through improvement of anaerobic threshold.</p></div><div id="abs1-11"><h4 class="inline">Future work:</h4><p>Results from the trial demonstrate that metabolic effect of rituximab is not translated into clinical benefit. This will help to guide us to design future trials and when looking at completely different targets.</p></div><div id="abs1-12"><h4 class="inline">Trial registration:</h4><p>Current Controlled Trials ISRCTN03978701, ClinicalTrials.gov identifier <a href="https://clinicaltrials.gov/show/NCT02376335" title="Study NCT02376335" ref="pagearea=abstract&targetsite=external&targetcat=link&targettype=clinical-trial">NCT02376335</a> and EudraCT number 2012-000145-12.</p></div><div id="abs1-13"><h4 class="inline">Funding:</h4><p>This project was funded by the National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation programme and will be published in full in <i>Efficacy and Mechanism Evaluation</i>; Vol. 5, No. 2. See the NIHR Journals Library website for further project information. Additional funding was received from the Medical Research Council and a Department of Health and Social Care subvention.</p></div></div><div><h2>Contents</h2><div class="bktoc_all_cntnr top align_right" style="display:none"><ul class="inline_list_right"><li><a class="bktoc_all_exp" href="#">Expand All</a></li><li style="margin-left:.8em"><a class="bktoc_all_clps" href="#">Collapse All</a></li></ul></div><ul id="toc_tllNBK499478_toc_abs2" class="simple-list toc toc-toggle"><li class="half_rhythm" id="toc_itm_NBK499478_toc_abs2"><a class="toc-item" href="/books/n/ukeme0502/abs2/">Plain English summary</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_abs3"><a class="toc-item" href="/books/n/ukeme0502/abs3/">Scientific summary</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s1"><a class="toc-item" href="/books/n/ukeme0502/s1/">Chapter 1. Introduction</a><ul id="toc_lst_NBK499478_toc_s1" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK499478_toc_s1-1"><a class="toc-item" href="/books/n/ukeme0502/s1/#s1-1">Scientific background and rationale</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s1-2"><a class="toc-item" href="/books/n/ukeme0502/s1/#s1-2">Study objectives</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s2"><a class="toc-item" href="/books/n/ukeme0502/s2/">Chapter 2. Methods</a><ul id="toc_lst_NBK499478_toc_s2" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK499478_toc_s2-1"><a class="toc-item" href="/books/n/ukeme0502/s2/#s2-1">Study conduct</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s2-2"><a class="toc-item" href="/books/n/ukeme0502/s2/#s2-2">Patient and public involvement</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s2-3"><a class="toc-item" href="/books/n/ukeme0502/s2/#s2-3">Trial design</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s2-4"><a class="toc-item" href="/books/n/ukeme0502/s2/#s2-4">Participants</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s2-5"><a class="toc-item" href="/books/n/ukeme0502/s2/#s2-5">Screening and recruitment processes</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s2-6"><a class="toc-item" href="/books/n/ukeme0502/s2/#s2-6">Intervention</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s2-7"><a class="toc-item" href="/books/n/ukeme0502/s2/#s2-7">Outcomes</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s2-8"><a class="toc-item" href="/books/n/ukeme0502/s2/#s2-8">Experimental assessments</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s2-9"><a class="toc-item" href="/books/n/ukeme0502/s2/#s2-9">Randomisation</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s2-10"><a class="toc-item" href="/books/n/ukeme0502/s2/#s2-10">Blinding</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s2-11"><a class="toc-item" href="/books/n/ukeme0502/s2/#s2-11">Data management and monitoring</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s2-12"><a class="toc-item" href="/books/n/ukeme0502/s2/#s2-12">Statistical methods</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s2-13"><a class="toc-item" href="/books/n/ukeme0502/s2/#s2-13">Safety</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s3"><a class="toc-item" href="/books/n/ukeme0502/s3/">Chapter 3. Results</a><ul id="toc_lst_NBK499478_toc_s3" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK499478_toc_s3-1"><a class="toc-item" href="/books/n/ukeme0502/s3/#s3-1">Participant flow</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s3-2"><a class="toc-item" href="/books/n/ukeme0502/s3/#s3-2">Recruitment</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s3-3"><a class="toc-item" href="/books/n/ukeme0502/s3/#s3-3">Numbers analysed</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s3-4"><a class="toc-item" href="/books/n/ukeme0502/s3/#s3-4">Outcomes and estimation</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s3-5"><a class="toc-item" href="/books/n/ukeme0502/s3/#s3-5">Ancillary analyses</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s3-6"><a class="toc-item" href="/books/n/ukeme0502/s3/#s3-6">Safety</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s4"><a class="toc-item" href="/books/n/ukeme0502/s4/">Chapter 4. Discussion</a><ul id="toc_lst_NBK499478_toc_s4" class="simple-list toc bktoc_lst_exp"><li class="half_rhythm" id="toc_itm_NBK499478_toc_s4-1"><a class="toc-item" href="/books/n/ukeme0502/s4/#s4-1">Summary of main findings</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s4-2"><a class="toc-item" href="/books/n/ukeme0502/s4/#s4-2">Strengths</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s4-3"><a class="toc-item" href="/books/n/ukeme0502/s4/#s4-3">Limitations</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s4-4"><a class="toc-item" href="/books/n/ukeme0502/s4/#s4-4">Interpretation</a></li></ul></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_s5"><a class="toc-item" href="/books/n/ukeme0502/s5/">Chapter 5. Conclusions</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_ack1"><a class="toc-item" href="/books/n/ukeme0502/ack1/">Acknowledgements</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_ref1"><a class="toc-item" href="/books/n/ukeme0502/ref1/">References</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_app1"><a class="toc-item" href="/books/n/ukeme0502/app1/">Appendix 1. Research and development approval</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_app2"><a class="toc-item" href="/books/n/ukeme0502/app2/">Appendix 2. Ethics/Research Ethics Committee approval</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_app3"><a class="toc-item" href="/books/n/ukeme0502/app3/">Appendix 3. Medicines and Healthcare products Regulatory Agency clinical trial authorisation approval</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_app4"><a class="toc-item" href="/books/n/ukeme0502/app4/">Appendix 4. Participant information sheet</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_app5"><a class="toc-item" href="/books/n/ukeme0502/app5/">Appendix 5. Standard operating procedure for sample handling</a></li><li class="half_rhythm" id="toc_itm_NBK499478_toc_g1"><a class="toc-item" href="/books/n/ukeme0502/g1/">List of abbreviations</a></li></ul><div class="bktoc_all_cntnr align_right" style="display:none"><ul class="inline_list_right"><li><a class="bktoc_all_exp" href="#">Expand All</a></li><li style="margin-left:.8em"><a class="bktoc_all_clps" href="#">Collapse All</a></li></ul></div></div><div class="pmc_boxed-text-box fm-sec whole_rhythm"><h3>About the Series</h3><div class="half_rhythm"><div>Efficacy and Mechanism Evaluation</div></div><div class="half_rhythm"><div>ISSN (Print): 2050-4365</div><div>ISSN (Electronic): 2050-4373</div></div></div><div><div id="n1-1"><h2>Article history</h2><p>The research reported in this issue of the journal was funded by the EME programme as project number 10/90/03. The contractual start date was in October 2012. The final report began editorial review in March 2017 and was accepted for publication in August 2017. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The EME editors and production house have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report.</p></div><div id="n1-2"><h2>Declared competing interests of authors</h2><p>Denise Howel was a member of Health Services and Delivery Research Commissioning Board until 30 November 2015.</p></div></div><p class="small">Last reviewed: March 2017; Accepted: August 2017.</p><div><dl class="temp-labeled-list small"><dt>†</dt><dd><div id="an2"><p class="no_top_margin">Joint authorship</p></div></dd></dl></div></div></div>
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<div class="post-content"><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright</a> © Queen’s Printer and Controller of HMSO 2018. This work was produced by Khanna <i>et al</i>. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.</div><div class="small"><span class="label">Bookshelf ID: NBK499478</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/29733563" title="PubMed record of this title" ref="pagearea=meta&targetsite=entrez&targetcat=link&targettype=pubmed">29733563</a></span>DOI: <a href="http://dx.crossref.org/10.3310/eme05020" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">10.3310/eme05020</a></div><div style="margin-top:2em" class="bk_noprnt"><div class="pagination bk_noprnt"><span class="inactive page_link prev">< Prev</span><a class="active page_link next" href="/books/n/ukeme0502/abs2/" title="Next page in this title">Next ></a></div></div></div></div>
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<div xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance"></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Views</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="PDF_download" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="/books/NBK499478/?report=reader">PubReader</a></li><li><a href="/books/NBK499478/?report=printable">Print View</a></li><li><a data-jig="ncbidialog" href="#_ncbi_dlg_citbx_NBK499478" data-jigconfig="width:400,modal:true">Cite this Page</a><div id="_ncbi_dlg_citbx_NBK499478" style="display:none" title="Cite this Page"><div class="bk_tt">Khanna A, Jopson L, Howel D, et al. Rituximab for the treatment of fatigue in primary biliary cholangitis (formerly primary biliary cirrhosis): a randomised controlled trial. Southampton (UK): NIHR Journals Library; 2018 Apr. (Efficacy and Mechanism Evaluation, No. 5.2.)<span class="bk_cite_avail"></span> doi: 10.3310/eme05020</div></div></li><li><a href="/books/n/ukeme0502/pdf/">PDF version of this title</a> (23M)</li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Other titles in this collection</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="source-links" id="Shutter"></a></div><div class="portlet_content"><ul xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="simple-list"><li><a href="/books/n/ukemecollect/">Efficacy and Mechanism Evaluation</a></li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Related information</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="discovery_db_links" id="Shutter"></a></div><div class="portlet_content"><ul><li class="brieflinkpopper"><a class="brieflinkpopperctrl" href="/books/?Db=nlmcatalog&DbFrom=books&Cmd=Link&LinkName=books_nlmcatalog&IdsFromResult=4534314" ref="log$=recordlinks">NLM Catalog</a><div class="brieflinkpop offscreen_noflow">Related NLM Catalog Entries</div></li></ul></div></div><div class="portlet"><div class="portlet_head"><div class="portlet_title"><h3><span>Similar articles in PubMed</span></h3></div><a name="Shutter" sid="1" href="#" class="portlet_shutter" title="Show/hide content" remembercollapsed="true" pgsec_name="PBooksDiscovery_RA" id="Shutter"></a></div><div class="portlet_content"><ul><li class="brieflinkpopper two_line"><a class="brieflinkpopperctrl" href="/pubmed/26297361" ref="ordinalpos=1&linkpos=1&log$=relatedarticles&logdbfrom=pubmed">RITPBC: B-cell depleting therapy (rituximab) as a treatment for fatigue in primary biliary cirrhosis: study protocol for a randomised controlled trial.</a><span class="source">[BMJ Open. 2015]</span><div class="brieflinkpop offscreen_noflow">RITPBC: B-cell depleting therapy (rituximab) as a treatment for fatigue in primary biliary cirrhosis: study protocol for a randomised controlled trial.<div class="brieflinkpopdesc"><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="author">Jopson L, Newton JL, Palmer J, Floudas A, Isaacs J, Qian J, Wilkinson J, Trenell M, Blamire A, Howel D, et al. </em><em xmlns:np="http://ncbi.gov/portal/XSLT/namespace" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" class="cit">BMJ Open. 2015 Aug 20; 5(8):e007985. 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