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Crohn Disease clinical trials

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NCT ID: NCT04274010 Terminated - Crohn Disease Clinical Trials

PANenteric Crohn's Capsule Versus Ileo-Colonoscopy and Scan Study

PAN-ICS
Start date: December 15, 2020
Phase: N/A
Study type: Interventional

Crohn's disease (CD) is a lifelong condition affecting the small and/or large bowel, causing diarrhoea, abdominal pain and weight loss. Patients with CD receive two tests to assess if the patients' CD is active, namely ileo-colonoscopy (camera examination of the large bowel, IC) and a scan of the small bowel (MRE). Together, these tests help determine if the patients' symptoms are due to CD, which is important as the medication to heal the bowel is strong. But, these investigations are uncomfortable, embarrassing, time-consuming and involve hospital visits to two separate departments. A new test involves swallowing a miniature camera, the size of a large vitamin pill (PillCamâ„¢ Crohn's (PCC)) that video-records the lining of the small and large bowel. Images are sent to a recorder worn over the tummy. The investigators aim to find out if the PCC capsule delivers a single test that is comparable to current tests (IC+MRE) for patients with CD. 125 patients with CD referred for IC+MRE will be recruited from 3 NHS hospitals. Each patient will undergo all three tests (IC+MRE and PCC). As there is a small risk of the capsule getting stuck (up to 3 in 100 patients), all patients will have a "dummy" capsule to check that the "real" capsule can travel safely through the bowel. If successful (checked with a handheld scanner and CT scan if required), patients proceed to PCC. Patients will receive bowel preparation (a drink to clean the bowel) prior to IC and PCC. The investigators will compare the findings of all three tests. The investigators will interview patients to find out their experiences to inform the way the test is introduced into practice. When consulted, local patients with CD felt the research question is extremely important and all preferred having one non-invasive test over two invasive and uncomfortable tests.

NCT ID: NCT04232228 Terminated - Crohn Disease Clinical Trials

A Study to Evaluate the Impact of Care4Today® IBD, a Smart System to Facilitate the Management of Crohn's Disease by Patients and Health Care Providers

Start date: February 7, 2020
Phase:
Study type: Observational

The purpose of this study is to describe the Crohn's Disease (CD)-related secondary healthcare resource utilisation of patients in the 6 months pre- and 12 months post-activation of Care4Today® inflammatory bowel disease (C4T IBD) alongside standard of care (SOC) in the management of CD.

NCT ID: NCT04131322 Terminated - Ulcerative Colitis Clinical Trials

Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.

ADA-SWITCH
Start date: October 10, 2019
Phase: Phase 4
Study type: Interventional

Loss of response of the Adalimumab biosimilar compared with the original drug.

NCT ID: NCT04102163 Terminated - Crohn Disease Clinical Trials

Health-Related Quality of Life in Crohn's Disease Participants With Complex Perianal Fistula Before and After Treatment

CALYPSO
Start date: January 26, 2021
Phase:
Study type: Observational

The purpose of this study is to assess the impact of treatment (medical and/or surgical) on Health-related Quality of Life (HRQoL) in participants with Crohn's Disease (CD) and Complex Perianal Fistula (CPF), by the Quality of Life in patients with Anal Fistula Questionnaire (QoLAF-Q), at 12 months after treatment initiation in routine clinical practice.

NCT ID: NCT04102111 Terminated - Crohn Disease Clinical Trials

A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease

PRISM
Start date: September 23, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of JNJ-active as measured by the change in the Crohn's Disease Activity Index (CDAI) score and Simplified Endoscopic Score for Crohn's disease (SES-CD) from baseline at Week 12.

NCT ID: NCT03994224 Terminated - Crohn Disease Clinical Trials

A Prospective Longitudinal Study of Fecal Microbiome and Calprotectin to Predict Response to Biological Therapy in Patients With CD

Start date: February 18, 2019
Phase:
Study type: Observational

Crohn's disease (CD) is a chronic relapsing-remitting systemic inflammatory disease, affecting any part of the gastrointestinal tract. Biological therapy with anti-tumor necrosis factor (TNF) alpha is the established treatment of choice for the management of moderate to severe Crohn's disease. However, its efficacy in an individual patient is the unpredictable and long-term outcome is still suboptimal. Identifying biomarkers which can predict treatment response is thus of utmost importance and can allow personalized management. In inflammatory bowel disease (IBD), altered fecal microbiota signatures have been consistently reported. Moreover, overall bacterial diversity is consistently decreased during intestinal inflammation. Fecal calprotectin (FC) is a calcium and zinc binding protein largely confined to the neutrophil granulocytes and macrophages and is a very sensitive marker for detection of inflammation in the gastrointestinal tract. C reactive protein (CRP) is an acute phase reactant. CD Patients with elevated baseline CRP levels responded to infliximab treatment better and early normalisation of CRP correlated with sustained long-term response to infliximab therapy. The investigators hypothesize that faecal microbial signatures in conjunction with faecal calprotectin and CRP may have a role in predicting response to biological therapy in CD patients.

NCT ID: NCT03961815 Terminated - Crohn's Disease Clinical Trials

Open-label Extension Study of Brazikumab in Crohn's Disease

INTREPID OLE
Start date: January 6, 2020
Phase: Phase 3
Study type: Interventional

The purpose of Study D5271C00002 (Legacy #3150-303-008) is to permit participants in D5271C00001 (Legacy #3150-301-008) to receive open-label brazikumab in Study D5271C00002 (Legacy #3150-303-008). This will permit long-term observation of safety in these participants with brazikumab.

NCT ID: NCT03943446 Terminated - Crohn Disease Clinical Trials

A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery

Start date: August 4, 2020
Phase: Phase 2
Study type: Interventional

The main aim is to see if TAK-018 reduces the recurrence of intestinal inflammation after abdominal resection surgery in adults with Crohn's disease. Participants will take either TAK-018 or placebo tablets by mouth, 2 times each day for up to 26 weeks after surgery. The placebo looks like TAK-018 but will not have any medicine in it. Participants will have 6 study visits while receiving treatment. Visits 1 and 6 will be conducted at the study clinic. The others can be in the clinic or at the participant's home. Follow-up will occur 4 weeks after final treatment.

NCT ID: NCT03870334 Terminated - Crohn's Disease Clinical Trials

Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease

Start date: May 5, 2021
Phase: Phase 2
Study type: Interventional

This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter induction study.

NCT ID: NCT03850509 Terminated - Crohn's Disease Clinical Trials

Efficacy and Safety of Oral OPS-2071 in Participants With Crohn's Disease Showing Symptoms of Active Inflammation

Start date: February 25, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effects and safety of OPS-2071 (150, 300, or 600 mg twice a day [BID]) versus placebo, as add-on therapy in participants with Crohn's disease who show symptoms of active inflammation despite being on ongoing treatment.