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<script type="text/javascript" src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.boots.min.js"> </script><title>Trial management, procedures and timelines - The efficacy and safety of ustekinumab in adolescents newly diagnosed with type 1 diabetes: the USTEK1D RCT - NCBI Bookshelf</title>
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<meta name="citation_date" content="2025/02">
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class="wsprkl btn" title="Jump to previuos match">◀</a><button id="jr-fip-matches">no matches yet</button><a id="jr-fip-next" class="wsprkl btn" title="Jump to next match">▶</a></nav></nav></div><div id="jr-epub-interstitial" class="hidden"></div><div id="jr-content"><article data-type="main"><div class="main-content lit-style" itemscope="itemscope" itemtype="http://schema.org/CreativeWork"><div class="meta-content fm-sec"><div class="fm-sec"><h1 id="_NBK612282_"><span class="label">Chapter 3</span><span class="title" itemprop="name">Trial management, procedures and timelines</span></h1><p class="fm-aai"><a href="#_NBK612282_pubdet_">Publication Details</a></p></div></div><div class="jig-ncbiinpagenav body-content whole_rhythm" data-jigconfig="allHeadingLevels: ['h2'],smoothScroll: false" itemprop="text"><div id="s3-1"><h2 id="_s3-1_">Trial timelines</h2><p>Funding timelines and milestones for the trial are described in <i><a href="/books/NBK612282/table/table2/?report=objectonly" target="object" rid-ob="figobtable2">Table 2</a></i>.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figtable2"><a href="/books/NBK612282/table/table2/?report=objectonly" target="object" title="TABLE 2" class="img_link icnblk_img" rid-ob="figobtable2"><img class="small-thumb" src="/corehtml/pmc/css/bookshelf/2.26/img/table-icon.gif" alt="Table Icon" /></a><div class="icnblk_cntnt"><h4 id="table2"><a href="/books/NBK612282/table/table2/?report=objectonly" target="object" rid-ob="figobtable2">TABLE 2</a></h4><p class="float-caption no_bottom_margin">Trial timelines </p></div></div></div><div id="s3-2"><h2 id="_s3-2_">Trial set-up</h2><p>The Trial Sponsor was Cardiff University, who were the employers of the Chief Investigator.</p><p>The study was conducted in collaboration with <a href="/books/n/ukeme1201/g1/?report=reader#g1-def46">STU</a>, a registered Clinical Trials Unit (UKCRN registration number 58) partly funded at that time by Health and Care Research Wales as part of their research infrastructure funding and with a specialist interest in diabetes trials. <a href="/books/n/ukeme1201/g1/?report=reader#g1-def46">STU</a> provided trial services including trial, data and pharmacovigilance management, site setup and close down and overseeing trial monitoring, ensuring that all procedures were Medicines and Healthcare products Regulatory Agency (MHRA) compliant.</p><p>The study was also supported by the <a href="/books/n/ukeme1201/g1/?report=reader#g1-def11">DRUC</a> laboratory who are co-located with <a href="/books/n/ukeme1201/g1/?report=reader#g1-def46">STU</a> at Swansea University and King’s College London (KCL).</p><p>The study was primarily funded by a grant from NIHR-EME (Ref: 16/36/01). <a href="/books/n/ukeme1201/g1/?report=reader#g1-def25">KCL</a> laboratories were also in receipt of funding from the Juvenile Diabetes Research Foundation for enhanced testing of blood samples investigated for USTEK1D. Funding was provided by Janssen-Cilag for pharmacokinetics and anti-drug antibody analysis.</p><p>Ethical approval was granted by Wales <a href="/books/n/ukeme1201/g1/?report=reader#g1-def39">REC</a> 3 reference 18/WA/0092 (IRAS ID 230113) on 14 June 2018 and the <a href="/books/n/ukeme1201/g1/?report=reader#g1-def27">MHRA</a> on 26 June 2018.</p><p>The trial had two oversight committees: a <a href="/books/n/ukeme1201/g1/?report=reader#g1-def51">TSC</a> and a <a href="/books/n/ukeme1201/g1/?report=reader#g1-def12">DSMB</a>. Independent members for both committees are listed in <i><a href="/books/n/ukeme1201/bn1/?report=reader#supp5">Report Supplementary Material 5</a></i>. Both met twice a year as a standard requirement and ad hoc meetings were held when the need arose. All independent members were pre-approved by the <a href="/books/n/ukeme1201/g1/?report=reader#g1-def29">NIHR</a> EME before reviewing and agreeing to a committee charter.</p><p>The Trial Management Group (TMG) met quarterly and a smaller trial team meeting occurred weekly. During recruitment and follow-up the trial team held open forums for sites to dial in twice a week with any questions or concerns.</p></div><div id="s3-3"><h2 id="_s3-3_">Accountability for trial medication</h2><div id="s3-3-1"><h3>Ustekinumab</h3><p>Janssen-Cilag Ltd supplied ustekinumab in the quantities required by the trial at no cost to the sponsor.</p><p>St Mary’s Pharmaceutical Unit (SMPU) was the appointed contractor for the receipt and storage of ustekinumab prior to distribution to trial sites. Storage was compliant with Annex 13 requirements. Ustekinumab was sent from <a href="/books/n/ukeme1201/g1/?report=reader#g1-def45">SMPU</a> to sites via their approved courier with a signature required on receipt by the relevant party. A nominated trial pharmacist at sites was responsible for the receipt and storage of the ustekinumab vials.</p><p>Ustekinumab does not contain an antimicrobial agent and has a shelf life of 2 years. Ustekinumab vials must be kept in their outer carton and stored in a refrigerator (2–8 °C) in a secure area with restricted access. Ustekinumab must not be frozen.</p><p>At sites, ustekinumab vials were checked for temperature violations and damage prior to accepting them for the trial.</p><p>Ustekinumab was administered within 4 hours of it being taken from the fridge. If this time was exceeded, the syringe was returned unused to pharmacy for disposal. The same time frame was applied to saline, even though it was stored at room temperature.</p></div><div id="s3-3-2"><h3>Placebo (control)</h3><p>The control treatment (saline 0.9%) was taken from local pharmacies stock in accordance with a signed sponsor agreement.</p><p>The saline did not contain an antimicrobial agent and had a shelf life of 3 years. Saline ampoules were stored below 25 °C in a secure area with restricted access.</p></div><div id="s3-3-3"><h3>Dispensing at sites</h3><p>Some sites were unable to dispense a blinded syringe within pharmacy and unblinded research nurses had to be trained to prepare the blinded syringe with local approval. Where home dosing was required during COVID-19 lockdown, pharmacies prepared either a blinded syringe or blinded vials with the necessary kit to allow home dosing, with an unblinded research nurse on video call to advise on preparation and administration and to observe the compliance of dosing.</p><p>Unused portions of <a href="/books/n/ukeme1201/g1/?report=reader#g1-def21">IMP</a> were never reused and were disposed of in accordance with local requirements. Detailed instructions for use of ustekinumab or control were available in the package leaflet.</p></div></div><div id="s3-4"><h2 id="_s3-4_">Safety</h2><p>A review of AEs was performed at all visits and eligibility/safety blood samples were drawn at screening and baseline, and at weeks 12, 28 and 52 to examine the full blood count; urea, electrolytes and creatinine; liver function tests; (total bilirubin, total protein, albumin, aspartate aminotransferase (serum glutamic oxaloacetic transaminase), serum glutamate pyruvate transaminase (alanine aminotransferase), alkaline phosphatase); thyroid-stimulating hormone; immunoglobulins (G, A, M); calcium; magnesium, phosphate, lipid profile (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglyceride). Urinalysis for pH, protein and albumin-to-creatinine ratio was carried out at screening and baseline, and at weeks 12, 28 and 52. A urine pregnancy test was completed on all females at all trial visits. PIs and other delegated medical staff at sites were expected to assess any values outside the laboratory reference range for clinical significance.</p><p>Participants were asked about new or unexpected symptoms at each visit. The diary was checked for any illnesses or diagnoses recorded since the last study visit.</p><p>Details of AEs were recorded from screening visit 2 until visit 8 at week 52, evidencing 8 weeks after the final dose.</p><p>Below are listed AEs that were considered expected for newly diagnosed <a href="/books/n/ukeme1201/g1/?report=reader#g1-def48">T1D</a> patients. If the events led to death, that was considered unexpected. These events could be classified and recorded as serious events but did not require immediate reporting to the <a href="/books/n/ukeme1201/g1/?report=reader#g1-def39">REC</a>:</p><ul><li class="half_rhythm"><div>hypoglycaemia</div></li><li class="half_rhythm"><div>diabetic ketoacidosis.</div></li></ul><p>All other AEs were assessed for seriousness, causality and expectedness in relation to the <a href="/books/n/ukeme1201/g1/?report=reader#g1-def21">IMP</a>.</p><p>Adverse reactions (ARs) and serious ARs (SARs) were evaluated for expectedness using the <a href="/books/n/ukeme1201/g1/?report=reader#g1-def40">RSI</a> below as based on knowledge of the reaction and the relevant product information documented in Section 4.8 of the <a href="/books/n/ukeme1201/g1/?report=reader#g1-def44">SmPC</a>. In summary, the expected side effects of ustekinumab were:</p><ul><li class="half_rhythm"><div>infections and infestations: upper respiratory tract infection, nasopharyngitis</div></li><li class="half_rhythm"><div>nervous system disorders: dizziness, headache</div></li><li class="half_rhythm"><div>respiratory, thoracic and mediastinal disorders: oropharyngeal pain</div></li><li class="half_rhythm"><div>gastrointestinal disorders: diarrhoea, nausea, vomiting</div></li><li class="half_rhythm"><div>skin and SC tissue disorders: pruritus</div></li><li class="half_rhythm"><div>musculoskeletal and connective tissue disorders: back pain, myalgia, arthralgia</div></li><li class="half_rhythm"><div>general disorders and administration site conditions: fatigue, injection site erythema, injection site pain.</div></li></ul><p>Safety data were continuously monitored throughout the study via <a href="/books/n/ukeme1201/g1/?report=reader#g1-def2">AE</a> logs and case report forms. Specific data items included AEs observed at each dosing visit and the week 52 follow-up visit, for example hypoglycaemic episodes; injection reactions (fever, chills, headache, nausea, vomiting and injection site pain); hypersensitivity reactions (signs and symptoms of anaphylaxis, angioedema, wheezing, dyspnoea, urticaria and hypotension). Other AEs to be reported included evidence of infection (Epstein–Barr virus, cytomegalovirus, <a href="/books/n/ukeme1201/g1/?report=reader#g1-def49">TB</a> or opportunistic bacteria) and evidence of posterior leucoencephalopathy syndrome.</p></div><div id="bk_toc_contnr"></div></div></div><div class="fm-sec"><h2 id="_NBK612282_pubdet_">Publication Details</h2><h3>Copyright</h3><div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright</a> © 2025 Carter <i>et al</i>.<p class="small">This work was produced by Carter <i>et al</i>. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. See: <a href="https://creativecommons.org/licenses/by/4.0/" ref="pagearea=meta&targetsite=external&targetcat=link&targettype=uri">https://creativecommons.org/licenses/by/4.0/</a>. For attribution the title, original author(s), the publication source – NIHR Journals Library, and the DOI of the publication must be cited.</p></div></div><h3>Publisher</h3><p><a href="http://www.journalslibrary.nihr.ac.uk/eme" ref="pagearea=page-banner&targetsite=external&targetcat=link&targettype=publisher">National Institute for Health and Care Research</a>, Southampton (UK)</p><h3>NLM Citation</h3><p>Carter K, Cheung WY, Hutchings HA, et al. The efficacy and safety of ustekinumab in adolescents newly diagnosed with type 1 diabetes: the USTEK1D RCT. Southampton (UK): National Institute for Health and Care Research; 2025 Feb. (Efficacy and Mechanism Evaluation, No. 12.01.) Chapter 3, Trial management, procedures and timelines.<span class="bk_cite_avail"></span></p></div><div class="small-screen-prev"><a href="/books/n/ukeme1201/s2/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M75,30 c-80,60 -80,0 0,60 c-30,-60 -30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Prev</text></svg></a></div><div class="small-screen-next"><a href="/books/n/ukeme1201/s4/?report=reader"><svg xmlns="http://www.w3.org/2000/svg" viewBox="0 0 100 100" preserveAspectRatio="none"><path d="M25,30c80,60 80,0 0,60 c30,-60 30,0 0,-60"></path><text x="20" y="28" textLength="60" style="font-size:25px">Next</text></svg></a></div></article><article data-type="table-wrap" id="figobtable2"><div id="table2" class="table"><h3><span class="label">TABLE 2</span></h3><div class="caption"><p>Trial timelines</p></div><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK612282/table/table2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__table2_lrgtbl__"><table id="t2"><thead><tr><th id="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Milestone</th><th id="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">Date</th></tr></thead><tbody><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Outline submission to National Institute for Health and Care Research Efficacy and Mechanism Evaluation (NIHR EME)</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">24 July 2016</td></tr><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Full submission</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">5 January 2017</td></tr><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Responses to feedback</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">31 May 2017</td></tr><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Final revision</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">6 July 2017</td></tr><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Funding letter issued</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">18 September 2017</td></tr><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Project start</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">1 November 2017</td></tr><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Collaboration Agreement signed</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">19 July 2018</td></tr><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Initial <a href="/books/n/ukeme1201/g1/?report=reader#g1-def39">REC</a> approval</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">14 June 2018</td></tr><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Initial MHRA approval</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">26 June 2018</td></tr><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Sponsor green light</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">7 November 2018</td></tr><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">First site opened</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">10 December 2018</td></tr><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">First participant consented</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">11 December 2018</td></tr><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">First participant randomised</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">14 December 2018</td></tr><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Recruitment halted due to COVID-19 pandemic</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">16 March 2020</td></tr><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Recruitment restarted after COVID-19 lockdown eased</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">3 July 2020</td></tr><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Last participant consented</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">5 August 2021</td></tr><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Last participant randomised</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">19 August 2021</td></tr><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Last participant completing 12 month follow-up visit</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">31 August 2022</td></tr><tr><td headers="hd_h_table2_1_1_1_1" rowspan="1" colspan="1" style="vertical-align:top;">Last participant completing the optional 24 month follow-up visit</td><td headers="hd_h_table2_1_1_1_2" rowspan="1" colspan="1" style="vertical-align:top;">31 August 2023</td></tr></tbody></table></div></div></article></div><div id="jr-scripts"><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/libs.min.js"> </script><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.min.js"> </script></div></div>
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