Active clinical trials for "Crohn Disease"

Crohn's disease (CD) is a chronic non-specific inflammatory disease of the intestine. Infliximab (IFX) is a kind of one of the anti-tumor necrosis factor agents (anti-TNF) and is the main clinical treatment drug for Crohn's disease, but approximately 30-50% of patients develop a secondary non-response to respond within one year. The main cause of secondary non-response failure is the formation of anti-IFX anti-drug antibodies (ADA). The human leukocyte antigen (HLA) gene is a complex allele that has been associated with susceptibility to a variety of diseases. Studies have shown that HLADQA1*05 allele carriage significantly increases the immunogenicity of anti-tumor necrosis factor agents (anti-TNF) and the risk of ADA formation, resulting in a significant reduction in the efficacy of IFX. Our previous retrospective study found an increased risk of ADA, IFX failure to respond and discontinuation in patients with HLADQA1*05 variants, and that IFX in combination with immunosuppression improved clinical outcomes in wild-type genotype patients, whereas combination therapy in patients with variant genotype did not optimize clinical outcomes significantly. Therefore, we believe that the impact of HLADQA1*05 on the efficacy of IFX in the Chinese population is unclear, and the combination of immunosuppressants in patients with variant HLADQA1*05 genotype remains to be validated due to insufficient sample size. We hypothesized that HLADQA1*05 wild-type CD patients would have better clinical remission when treated with IFX than HLADQA1*05 variant patients and that the combination of immunosuppressants would improve the outcome in wild-type patients but not in variant patients. By advancing this project, we hope to provide high quality evidence on the clinical use of IFX in Crohn's disease in the Chinese population and help physicians to be more selective in the use of IFX alone or in combination with azathioprine, or to switch treatment in a timely manner.

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective risankizumab is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed. Risankizumab is a drug approved for the treatment of CD. All study participants will receive risankizumab as prescribed by their study doctor in accordance with approved local label. Approximately 1000 participants will be enrolled worldwide. Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 36 months. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.

The primary purpose of this study is to evaluate the efficacy and safety of intravenous administration at regular intervals of Ustekinumab in participants with loss of response to standard regimen or have evidence of high activity clinically, biochemically or endoscopically.

The MUSIC study is a multi-centre, longitudinal study set in the real world IBD clinical setting to investigate and develop a new biomarker approach that aims to inform both patients and clinicians of the current state of the affected gut lining (how inflamed or whether the bowel wall has completely healed). This new biomarker approach will study a panel of molecular signs in IBD patients' blood, stools and biopsies that will be correlated to the current gold standard of direct gut visual examination using ileo-colonoscopy and flexible sigmoidoscopy tests (a fibre-optic examination of the lower small bowel and large bowel). Here, the state and appearances of IBD patients' gut lining will be assessed over one year in response to treatment given to them by their NHS IBD consultant. This approach will focus on the role of damage associated molecular patterns (DAMPs), also known as 'danger signals'. DAMPs are found in our own cells and are released during tissue stress or injury. Like signals from bacteria, they can trigger inflammation. In the MUSIC study, blood, stool, saliva and gut samples obtained from participants during active IBD and in clinical remission will be used in order to understand how DAMPs contribute to the development of gut inflammation.

In this study, participants with ulcerative colitis or Crohn's disease or pouchitis will be treated with Kynteles injection (Vedolizumab) according to their clinic's standard practice. The main aim of the study is to check for side effects from treatment with Kynteles injection (Vedolizumab). Another aim is to learn how many participants have improved symptoms after treatment with Kynteles injection (Vedolizumab).

The purpose of the study is to determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric participants with inflammatory bowel disease.

The purpose of this survey is to evaluate the long-term safety and effectiveness of vedolizumab for intravenous (IV) infusion 300 milligrams (mg) in Crohn's disease (CD) patients in the routine clinical setting.

The purpose of this study is to evaluate the safety and tolerability of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease

The study is to determine whether active surgical intervention promotes disease remission in patients with Crohn's Disease (CD).The management of CD involves both maintenance medication and medication used to control flares of the disease. The goal of maintenance therapy in CD is to maintain steroid- free remission, clinically and endoscopically. This requires regular clinical assessment including history, physical examination and at times colonoscopic examination. Other tools of assessment include blood (e.g. CRP, WCC) and stool (calprotectin) testing for inflammatory markers and imaging including MRI, CT or ultrasound. The choice of maintenance treatment in CD is determined by disease extent, disease course (frequency of flares), failure of previous maintenance treatment, severity of the most recent flare, treatment used for inducing remission during the most recent flare, safety of maintenance treatment, and cancer prevention. The mainstay of maintenance medication are the 5-aminosalicylic acid compounds (5-ASA) such as mesalazine or sulphasalazine. These compounds are commonly taken orally in formulations that predominantly deliver the active 5-ASA component to the colon. Alternatively, or in addition, mesalazine preparations can be delivered topically via enema or suppository if the disease only involves the left side of the colon (although it is only PBS funded for topical therapy during a flare and not for maintenance of remission - even though it also works in this setting). The majority of patients can be managed with maintenance 5-ASA compounds most of the time. For patients who have repeated flares of disease on 5-ASA maintenance therapy (1 or more flares in a year needing steroids), thiopurine medication such as azathioprine or 6-mercapropurine should be used. These medications induce systemic immunosuppression, reduce the incidence and severity of flares of colitis but also slightly increase the risk of some infections and malignancy. Anti TNF agents such as infliximab or adalimumab have been shown to have benefit in maintaining remission in CD (and are licensed for this indication by the TGA), however these agents are very expensive and not funded by the pharmaceutical benefits scheme in Australia and so, are not readily available. The anti TNF agents also give an increased risk of infection, particularly latent TB reactivation. Mild flares of CD can be managed with higher doses of oral 5-ASA compounds or the addition of topical 5-ASAs given via enema or suppository. More severe flares are usually managed with a course of systemic corticosteroid. These can be given intravenously in acute, severe disease or orally in less severe flares. The steroids should then be tapered over time and discontinued. There is no indication for long term steroid use in CD and prolonged steroid use is associated with a number of complications including infection, osteoporosis, obesity, diabetes, poor wound healing, thinning skin, mood changes and insomnia. Severe flares of CD not responsive to steroids may respond to rescue therapy with the addition of either cyclosporin or anti-TNF therapy. Patients in whom colonic inflammation cannot be controlled adequately frequently undergo total colectomy. This may be done electively (for refractory disease) or emergently in acute fulminant colitis. Colectomy entails surgical risk that is higher in the emergent setting; this risk includes infection, wound breakdown and a mortality rate. Colectomy is considered "curative" for CD especially if they have an ileostomy stoma created, however, it frequently also leads to complications both short- and long-term. In addition, in patients in whom an ileal-anal pouch is fashioned up to 50% will subsequently develop pouchitis at 4 years post surgery. Patient eligibility was determined during a 5-week screening period, during which time details on patient demographics, medical history, and previous and concomitant medications were obtained,and the following assessments were completed: viral serology, stool culture, Crohn's Disease Activity Index (CDAI) patient diary and clinical score, Simple Endoscopic Score for Crohn's Disease (SES-CD), colonoscopy and colonic biopsy, stool collection for faecal biomarkers, vital signs, and laboratory evaluations. All participants need to be subjected to rigorous assessments mentioned above at week 4, week 8 and week 12 after receiving active surgical intervention (two kinds: one is colostomy, and the other one is colonic exclusion).

multicentre randomized controlled prospective study aimed at evaluating the efficacy of the infiltration of microfractured adipose tissue in the healing of perianal fistulas not-responding to treatment with biologics, in order to improve the quality of life and significantly reduce the risk of definitive ostomy.