Abstract:
BACKGROUND:Juvenile idiopathic arthritis (JIA)-associated uveitis is a chronic paediatric ocular inflammatory condition that can result in visual impairment. Adalimumab, a tumour necrosis factor (TNF)-alpha inhibitor, effectively controls joint and eye inflammation; however, its long-term use may increase the risk of adverse health outcomes and place an undue financial burden on the patient and healthcare system given its high cost. There is great interest for patients to stop adalimumab following remission due to these reasons but there is a lack of information on the ability to maintain control after discontinuing adalimumab. METHODS:The Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Trial (ADJUST) is a multicentred, international trial that will randomise 118 participants aged 2 years and older with controlled JIA-associated uveitis to either continue adalimumab or discontinue adalimumab and receive a placebo. The trial will compare the time to uveitis recurrence between the two groups over 12 months. All participants will receive the standard weight-based dose of adalimumab or placebo: 20 mg biweekly (if < 30 kg) or 40 mg biweekly (if ≥ 30 kg). DISCUSSION:This is the first randomised controlled trial to assess the efficacy of discontinuing adalimumab after demonstrating control of JIA-associated uveitis for at least 12 months. The results of ADJUST will provide information on clinical outcomes to guide clinicians in their decision-making regarding discontinuation of adalimumab. TRIAL REGISTRATION:ClinicalTrials.gov NCT03816397. Registered on 25 January 2019. EudraCT 2019-000412-29. Registered on 17 January 2019.
journal_name
Trialsjournal_title
Trialsauthors
Acharya NR,Ebert CD,Kelly NK,Porco TC,Ramanan AV,Arnold BF,ADJUST Research Group.doi
10.1186/s13063-020-04796-zsubject
Has Abstractpub_date
2020-10-27 00:00:00pages
887issue
1issn
1745-6215pii
10.1186/s13063-020-04796-zjournal_volume
21pub_type
杂志文章相关文献
Trials文献大全abstract:BACKGROUND:The cross-sectional area of the subclavian vein (csSCV) is an important factor determining the success rate of SCV catheterization. The head-down position increases the csSCV. However, the effects of lateral tilting on subclavian venous cross-sectional area have not yet been explored. In this trial, we test ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2666-8
更新日期:2018-05-24 00:00:00
abstract:BACKGROUND:In coronary artery bypass grafting surgery, arterial conduits are preferred because of more favourable long-term patency and outcome. Anyway the greater saphenous vein continues to be the most commonly used bypass conduit. Minimally invasive endoscopic saphenous vein harvesting is increasingly being investig...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-12-243
更新日期:2011-11-18 00:00:00
abstract:BACKGROUND:Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery. POAF is associated with increased morbidity and hospital costs. We herein describe the protocol for a randomized controlled trial to determine if performing a posterior left pericardiotomy prevents POAF after cardiac...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-017-2334-4
更新日期:2017-12-13 00:00:00
abstract:BACKGROUND:Noncompliance to treatment assignment is an inevitable occurrence in randomized clinical trials (RCTs). Intention to treat (ITT) is generally considered the best method for addressing noncompliance in RCTs. Alternatives to ITT exist, including per protocol (PP), as treated (AT), and instrumental variables (I...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-015-1044-z
更新日期:2015-11-17 00:00:00
abstract:BACKGROUND:Patients can struggle to make sense of trials in emergency situations. This study examines patient experience of participating in the United Kingdom, Wound management of Open Lower Limb Fractures (UK WOLLF) study, a trial of standard wound management versus Negative Pressure Wound Therapy (NPWT). METHODS:Th...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-018-2722-4
更新日期:2018-06-25 00:00:00
abstract:BACKGROUND:Basal cell carcinoma is the most common skin cancer worldwide. Treatment options include both surgical and topical modalities. Although risk of metastasis is low, basal cell carcinoma can be invasive and infiltrate important underlying structures such as bone or cartilage. While many clinical trials examinin...
journal_title:Trials
pub_type: 共识发展会议,杂志文章
doi:10.1186/s13063-017-2244-5
更新日期:2017-10-23 00:00:00
abstract:BACKGROUND:In Germany, clinical trials and comparative effectiveness studies in primary care are still very rare, while their usefulness has been recognised in many other countries. A network of researchers from German academic general practice has explored the reasons for this discrepancy. METHODS:Based on a comprehe...
journal_title:Trials
pub_type: 杂志文章,评审
doi:10.1186/1745-6215-13-205
更新日期:2012-11-08 00:00:00
abstract:BACKGROUND:Registration of clinical trials is critical for promoting transparency and integrity in medical research; however, trials must be registered in a prospective fashion to deter unaccounted protocol modifications or selection of alternate outcomes that may enhance favorability of reported findings. We assessed ...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2825-y
更新日期:2018-08-23 00:00:00
abstract:BACKGROUND:Randomised controlled trials are being increasingly used to evaluate new surgical interventions. There are a number of problematic methodological issues specific to surgical trials, the most important being identifying whether patients are eligible for recruitment into the trial. This is in part due to the d...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-12-258
更新日期:2011-12-13 00:00:00
abstract::There is a critical need for objective data to guide effective health promotion and care for homeless populations. However, many investigators exclude homeless populations from clinical trials due to practical concerns about conducting research with this population. This report is based on our experience and lessons l...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-017-2046-9
更新日期:2017-07-05 00:00:00
abstract:BACKGROUND:Depression is not a normal side effect of aging, however it is one of the most prevalent mental health issues in later life, imposing a tremendous burden on patients, their families, and the healthcare system. We describe the experimental implementation of a collaborative, stepped-care model for the treatmen...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-15-351
更新日期:2014-09-06 00:00:00
abstract:BACKGROUND:Chronic back pain continues to be a costly and prevalent condition. The latest NICE guidelines issued in 2009 state that for patients with persistent back pain (of between six weeks and twelve months duration), who are highly distressed and/or disabled and for whom exercise, manual therapy and acupuncture ha...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-14-172
更新日期:2013-06-13 00:00:00
abstract::Randomised controlled trials are the best research design for decisions about the effect of different interventions but randomisation does not, of itself, promote the applicability of a trial's results to situations other than the precise one in which the trial was done. While methodologists and trialists have rightly...
journal_title:Trials
pub_type: 杂志文章,评审
doi:10.1186/1745-6215-10-37
更新日期:2009-06-03 00:00:00
abstract:BACKGROUND:Renal transplantation represents the treatment of choice of end-stage kidney disease. Delayed graft function (DGF) remains the most frequent complication after this procedure, reaching more than 30%. Its prevention is essential as it impedes early- and long-term prognosis of transplantation. Numerous pharmac...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2597-4
更新日期:2018-04-17 00:00:00
abstract:BACKGROUND:Acupuncture is a widely serviced complementary medicine. Although acupuncture is suggested for managing postoperative ileus and pain, supporting evidence is weak. The AcuLap trial is designed to provide high-level evidence regarding whether or not electroacupuncture is effective in promoting gastrointestinal...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-015-0981-x
更新日期:2015-10-14 00:00:00
abstract:BACKGROUND:The key aim of the study is to establish an agreed standardised core outcome set (COS) for use when evaluating non-pharmacological health and social care interventions for people living at home with dementia. METHODS/DESIGN:Drawing on the guidance and approaches of the Core Outcome Measures in Effectiveness...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2584-9
更新日期:2018-04-24 00:00:00
abstract:BACKGROUND:Obesity affects 25% of the UK adult population but modest weight loss can reduce the incidence of obesity-related chronic disease. Some effective weight loss treatments exist but there is no nationally available National Health Service (NHS) treatment service, and general practitioners (GPs) rarely discuss w...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-393
更新日期:2013-11-19 00:00:00
abstract:BACKGROUND:Dietary interventions have limited success in promoting sustainable weight loss; new treatments allowing better compliance with hypocaloric diets should be developed. The aim of this trial is to describe the effects of a protocol combining repetitive active transcranial direct current stimulation (tDCS) with...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2776-3
更新日期:2018-07-16 00:00:00
abstract:BACKGROUND:Quality and service improvement (QSI) research employs a broad range of methods to enhance the efficiency of healthcare delivery. QSI research differs from traditional healthcare research and poses unique ethical questions. Since QSI research aims to generate knowledge to enhance quality improvement efforts,...
journal_title:Trials
pub_type: 信件
doi:10.1186/s13063-018-2724-2
更新日期:2018-06-25 00:00:00
abstract:BACKGROUND:The oversight and conduct of a randomised controlled trial involves several stakeholders, including a Trial Steering Committee (TSC), Trial Management Group (TMG), Data Monitoring Committee (DMC), funder and sponsor. We aimed to examine how the relationships between these stakeholders affect the trial oversi...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-017-2305-9
更新日期:2017-12-22 00:00:00
abstract:BACKGROUND:Osteoarthritis (OA) is the most prevalent chronic joint disease, characterized by joint structural deterioration, pain and loss of function among the elders. It is also associated with several extra-articular symptoms (fatigue, sleep disorders, anxiety and depression) and a reduction of life quality. Studies...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-018-2625-4
更新日期:2018-04-17 00:00:00
abstract:BACKGROUND:Intellectual disability (ID) is characterized by limitations in intellectual functioning and adaptive behavior. Adults with ID exhibit higher rates of obesity and poorer health status compared to the general population. Continuity of care and barriers to health-related activities may contribute to the poorer...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-017-2239-2
更新日期:2017-10-23 00:00:00
abstract:BACKGROUND:Many people living with HIV suffer from depressive symptoms. In a previous pilot study, self-help cognitive behavioral therapy (in booklet format) was found to be effective in treating depressive symptoms in people with HIV. We developed an online self-help program in Dutch and English (based on the booklet)...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s13063-016-1292-6
更新日期:2016-03-31 00:00:00
abstract:BACKGROUND:Research shows that more than half of the people taking medication for a chronic condition are non-adherent. Nonadherence hinders disease control with a burden on patient quality of life and healthcare systems. We developed a tool that provides insight into nonadherence risks and barriers for medication-adhe...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/s13063-016-1393-2
更新日期:2016-06-03 00:00:00
abstract:BACKGROUND:Neck pain caused by cervical spondylosis (CS) has become one of the most common health problems around the world. Electroacupuncture (EA) has been employed to relieve CS neck pain, but there is limited clinical evidence for its effectiveness. METHODS/DESIGN:This study consists of a randomized controlled tri...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-360
更新日期:2013-10-29 00:00:00
abstract:BACKGROUND:Maori, the indigenous people of New Zealand, who present to hospital after intentionally harming themselves, do so at a higher rate than non-Maori. There have been no previous treatment trials in Maori who self harm and previous reviews of interventions in other populations have been inconclusive as existing...
journal_title:Trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/1745-6215-12-117
更新日期:2011-05-11 00:00:00
abstract:BACKGROUND:Qualitative methods are increasingly used to study the process of clinical trials and patients understanding of the rationale for trials, randomisation and reasons for taking part or refusing. Patients' understandings are inevitably influenced by the recruiting clinician's understanding of the trial, yet rel...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/1745-6215-8-4
更新日期:2007-01-27 00:00:00
abstract:BACKGROUND:Current guidelines recommend treatment of significant coronary artery disease by concomitant coronary artery bypass grafting (CABG) in patients undergoing surgical aortic valve replacement. However there is no consensus as to how best to treat coronary disease in high-risk patients requiring transcatheter ao...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-15-300
更新日期:2014-07-24 00:00:00
abstract:BACKGROUND:Trigeminal neuralgia (TN) is a rare severe unilateral facial pain condition. Current guidelines in trigeminal neuralgia management recommend sodium channel blockers--carbamazepine or oxcarbazepine--as the first-line treatment. However, the currently available drugs are often associated with poor tolerability...
journal_title:Trials
pub_type: 杂志文章,随机对照试验
doi:10.1186/1745-6215-14-402
更新日期:2013-11-23 00:00:00
abstract:BACKGROUND:Failure to collect outcome data in randomised trials can result in bias and loss of statistical power. Further evaluations of strategies to increase retention are required. We assessed the effectiveness of two strategies for retention in a randomised prevention trial using a two-by-two factorial randomised s...
journal_title:Trials
pub_type: 杂志文章
doi:10.1186/s13063-020-04373-4
更新日期:2020-06-08 00:00:00