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Clinical trials in ibd

Karen E James, Rui Xiao, Peter A Merkel, Pamela F Weiss
OBJECTIVES: To characterise the clinical course and outcomes of a cohort of children with granulomatosis with polyangiitis (GPA). METHODS: Retrospective cohort study of children diagnosed with GPA in a tertiary care facility from 2000-2014. All subjects met the American College of Rheumatology 1990 criteria for GPA or the 2008 European League against Rheumatism/Paediatric Rheumatology International Trials Organisation/Paediatric Rheumatology European Society criteria for GPA...
October 6, 2016: Clinical and Experimental Rheumatology
Ruey Terng Ng, Way Seah Lee, Hak Lee Ang, Kai Ming Teo, Yee Ian Yik, Nai Ming Lai
BACKGROUND: Childhood constipation is a common problem with substantial health, economic and emotional burdens. Existing therapeutic options, mainly pharmacological, are not consistently effective, and some are associated with adverse effects after prolonged use. Transcutaneous electrical stimulation (TES), a non-pharmacological approach, is postulated to facilitate bowel movement by modulating the nerves of the large bowel via the application of electrical current transmitted through the abdominal wall...
October 12, 2016: Cochrane Database of Systematic Reviews
Sunhee Park, Tsion Abdi, Mark Gentry, Loren Laine
OBJECTIVES: Endoscopic remission in ulcerative colitis (UC) is associated with improved clinical outcomes. We assessed whether histological remission predicts clinical outcomes, estimated the magnitude of effect, and determined whether histological remission provides additional prognostic utility beyond clinical or endoscopic remission. METHODS: Bibliographic databases were searched for studies in inflammatory bowel disease providing baseline histological status and relation to an outcome of clinical relapse or exacerbation...
October 11, 2016: American Journal of Gastroenterology
Jin-Hee Park, Yong-Chul Kim
The P2X7 receptor (P2X7R) is a unique subtype among the family of seven purinergic P2X receptors, which are ATP-gated non-selective cation channels. P2X7R has been reported to have pathological roles in various diseases, including autoimmune diseases such as arthritis and inflammatory bowel disease, neurodegenerative diseases, chronic pain, mood disorders and cancers. Therefore, many pharmaceutical companies have endeavored to develop a clinical candidate targeting P2X7R. Areas covered: This review provides a summary of various patents on chemicals and biologics and their clinical use published between 2010 and 2015...
October 10, 2016: Expert Opinion on Therapeutic Patents
U Gehrmann, U Berger, N Teich, T Bruns, A Stallmach, M Weber
Background: Clinical trials are designed to investigate innovative diagnostic and therapeutic strategies for patients. However, factors that influence patients with inflammatory bowel disease (IBD) and willingness to participate in a clinical trial are unknown. Methods: We developed a questionnaire and asked IBD patients about their willingness to hypothetically participate in a clinical trial and their current health-related quality of life by using the IBDQ. Results: Of 201 distributed questionnaires, 166 were returned and included in the analysis...
October 2016: Zeitschrift Für Gastroenterologie
Alessandro Menozzi, Manuel Dall'Aglio, Fausto Quintavalla, Luca Dallavalle, Valentina Meucci, Simone Bertini
BACKGROUND: A clinical trial was conducted in order to assess the efficacy of rifaximin, a broad-spectrum antibiotic with negligible gastrointestinal absorption, in comparison with metronidazole, a commonly employed antimicrobial drug, in dogs with chronic enteropathy. Twenty-four pet dogs were randomly enrolled into two different groups: MET group (10 dogs) and RIF group (14 dogs). Dogs of MET group received metronidazole 15 mg/kg q12h for 21 days by oral route, whereas dogs of RIF group, were given rifaximin 25 mg/kg q12h for 21 days by oral route...
October 6, 2016: BMC Veterinary Research
A Stallmach, C Langbein, R Atreya, T Bruns, A Dignass, K Ende, J Hampe, F Hartmann, M F Neurath, J Maul, J C Preiss, R Schmelz, B Siegmund, H Schulze, N Teich, U von Arnim, D C Baumgart, C Schmidt
BACKGROUND: Vedolizumab, a monoclonal antibody targeting the α4β7-integrin, is effective in inducing and maintaining clinical remission in Crohn's disease and ulcerative colitis according to randomised clinical trials. AIM: To determine the long-term effectiveness of vedolizumab in a real-world clinical setting. METHODS: This observational registry assessed the clinical outcome in patients treated with vedolizumab for clinically active Crohn's disease (n = 67) or ulcerative colitis (n = 60)...
October 7, 2016: Alimentary Pharmacology & Therapeutics
Dr Dharmendra Kanoriya, Dr A R Pradeep, Dr Vibhuti Garg, Dr Sandeep Singhal
BACKGROUND: Different materials have been instigated for renewal of lost supporting periodontal structures and tested for furcation defects treatment. Platelet-rich fibrin (PRF) is a pool of growth promoting factors and cytokines which promotes bone regeneration and maturation of soft tissue. Alendronate (ALN), an influential member of bisphosphonate group is known to enhance osteoblastogenesis and inhibits osteoclastic bone resorption, thus promoting tissue regeneration. This randomized trial was done to assess the effectiveness of PRF and 1% ALN gel combination in mandibular degree II furcation defects treatment in comparison to PRF and access therapy alone...
October 7, 2016: Journal of Periodontology
Konstantinos H Katsanos, Efstratios Koutroumpakis, Eftychia Giagkou, Zikos Malakos, Eleni Almpani, Alexandros Skamnelos, Dimitrios K Christodoulou
Fast-track drug designation of safe regimens represents an emerging method of development and approval of new medications targeting debilitating diseases including inflammatory bowel diseases (IBD). The goal of accelerated drug approval pathways is to shorten the time between application and approval of therapies that treat diseases with significant morbidity and mortality. Recently, fast-track drug approval approaches were supported by data deriving from central reading of images, a method of clinical data interpretation that has significantly benefited patients with gastrointestinal disorders...
October 2016: Annals of Gastroenterology: Quarterly Publication of the Hellenic Society of Gastroenterology
Daperno Marco, Comberlato Michele, Bossa Fabrizio, Alessandro Armuzzi, Biancone Livia, Bonanomi G Andrea, Cosintino Rocco, Lombardi Giovanni, Mangiarotti Roberto, Papa Alfredo, Pica Roberta, Luca Grassano, Pagana Guido, D'Incà Renata, Orlando Ambrogio, Rizzello Fernando
BACKGROUNDS AND AIMS: Endoscopic outcomes are increasingly used in clinical trials and in routine practice for inflammatory bowel disease (IBD), in order to reach more objective patient evaluations than using only clinical features. However reproducibility of endoscopic scoring systems used to categorize endoscopic activity was reported to be suboptimal.Aim of this study was to analyse the inter-rated agreement of non-dedicated Gastroenterologists on IBD endoscopic scoring systems, and to explore the effects of a dedicated training programme on agreement...
October 4, 2016: Journal of Crohn's & Colitis
Marianne Kiszka-Kanowitz, Klaus Theede, Anette Mertz-Nielsen
BACKGROUND: Treating inflammatory bowel diseases (IBD) using thiopurines is effective; however, a high rate of adverse effects and lack of efficacy limit its use. Retrospective studies have suggested that treatment with low-dose thiopurines in combination with allopurinol is associated with higher remission rates and lower incidence of adverse events. AIM: To compare the rates of clinical remission and the rates of adverse events in IBD patients treated with either standard treatment with azathioprine or low-dose azathioprine in combination with allopurinol...
December 2016: Scandinavian Journal of Gastroenterology
Laura Martelli, Pablo Olivera, Xavier Roblin, Alain Attar, Laurent Peyrin-Biroulet
BACKGROUND: Therapeutic drug monitoring (TDM) of anti-TNF is increasingly used to manage inflammatory bowel diseases (IBD) and rheumatoid arthritis (RA). The cost-effectiveness of this strategy is debated. METHODS: All studies comparing the cost-effectiveness of a TDM-based strategy and an empirical dose management of anti-TNF in IBD or RA were screened. Studies were identified through the MEDLINE electronic database (up to July 2016), and annual international meeting abstracts were also manually reviewed...
September 24, 2016: Journal of Gastroenterology
Antonina Mikocka-Walus, Patrick A Hughes, Peter Bampton, Andrea Gordon, Melissa A Campaniello, Chris Mavrangelos, Benjamin J Stewart, Adrian Esterman, Jane M Andrews
BACKGROUND AND AIMS: Previous studies have shown that antidepressants reduce inflammation in animal models of colitis. The present trial aimed to examine whether fluoxetine added to standard therapy for Crohn's disease (CD) maintained remission, improved quality of life and/or mental health in people with CD as compared to placebo. METHODS: A parallel randomised double-blind placebo controlled trial was conducted. Participants with clinically established CD, with quiescent or only mild disease, were randomly assigned to receive either fluoxetine 20mg daily or placebo, and followed for 12 months...
September 23, 2016: Journal of Crohn's & Colitis
Laurent Peyrin-Biroulet, Corinne Gower-Rousseau
No abstract text is available yet for this article.
September 23, 2016: Journal of Crohn's & Colitis
Szilamér Ferenczi, Krisztián Szegi, Zsuzsanna Winkler, Teréz Barna, Krisztina J Kovács
Inflammatory bowel disease shows increasing prevalence, however its pathomechanism and treatment is not fully resolved. Prebiotics are non-digestible carbohydrates which might provide an alternative to treat inflammatory conditions in the gut due to their positive effects either on the microbiome or through their direct effect on macrophages and mucosa. To test the protective effects of an oligomannan prebiotic, yeast cell wall mannooligosaccharide (MOS) was administered in dextran-sulphate-sodium (DSS)-induced mouse model of acute colitis...
2016: Scientific Reports
Vincenzo Villanacci, Filip Baert, Freddy Cornillie, Gert De Hertogh, Julián Panés
In patients with inflammatory bowel disease, a dissociation can occur between symptoms and presence of inflammatory lesions. This dissociation has led to the recognition that objective measures of disease activity together with clinical assessment should be co-primary endpoints in clinical trials. Objective assessment of inflammatory lesions has classically relied on ileocolonoscopy. However, examination with endoscopy cannot always be complete and does not evaluate transmural changes. Furthermore, histological alterations may persist in the presence of mild or even absent endoscopy lesions...
September 20, 2016: Journal of Crohn's & Colitis
Hannah A Blair, Emma D Deeks
Infliximab biosimilar (CT-P13/infliximab-dyyb; Remsima(®), Inflectra(®)) is approved in several countries for use in all indications for which reference infliximab (Remicade(®)) is approved, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, psoriasis, Crohn's disease, and ulcerative colitis. Clinical data contributing to the EU approval of infliximab biosimilar were obtained from two pivotal double-blind clinical trials in patients with AS (PLANETAS) or RA (PLANETRA)...
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Elena Moroz, Soo Hyeon Lee, Ken Yamada, François Halloy, Saúl Martínez-Montero, Hartmut Jahns, Jonathan Hall, Masad J Damha, Bastien Castagner, Jean-Christophe Leroux
Nucleic acid therapy can be beneficial for the local treatment of gastrointestinal diseases that currently lack appropriate treatments. Indeed, several oligonucleotides (ONs) are currently progressing through clinical trials as potential treatments for inflammatory bowel diseases. However, due to low uptake of carrier-free ONs by mucosal cells, strategies aimed at increasing the potency of orally administered ONs would be highly desirable. In this work, we explored the silencing properties of chemically modified and highly resistant ONs derivatized with hydrophobic alkyl chain on intestinal epithelial cells...
2016: Molecular Therapy. Nucleic Acids
Edward L Barnes, Alison Goldin, Rachel W Winter, Emily Collins, Bonnie Cao, Madeline Carrellas, Anne Marie Crowell, Joshua R Korzenik
BACKGROUND: The benefits of combination therapy with infliximab and azathioprine have been demonstrated in clinical trials of patients with ulcerative colitis (UC) and Crohn's disease (CD). Concerns remain regarding the ideal duration and benefits of adding therapies in a sequential manner. AIMS: We aim to compare long-term outcomes among patients with inflammatory bowel disease (IBD) treated with sequentially added combination therapy or monotherapy strategies ...
November 2016: Digestive Diseases and Sciences
Krisztina B Gecse, Péter L Lakatos
Biosimilars are biologic medicines that enter the market after a patent for an original reference product expires. The European Medicines Agency (EMA) developed a stringent legislation process for biosimilar monoclonal antibodies, whereby similarity to the reference medicinal product in terms of quality characteristics, biological activity, clinical safety and efficacy must be demonstrated. Biosimilar infliximab CT-P13 was the first biosimilar monoclonal antibody to receive EMA marketing authorization, and further biosimilar molecules are being developed...
October 2016: Drugs
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