Prevalence of Small Bowel Inflammatory Crohn's Disease Lesions in Patients With Spondyloarthropathies (SpA): A Prospective Capsule Endoscopy-Based Study
Inflammatory bowel disease is clinically associated with spondylarthropathies in 5-15% of cases. Protocol colonoscopic assessment demonstrated asymptomatic inflammation characteristic of Crohn's disease in up to 1/3 of SpA patients. Videocapsule endoscopy is a superior diagnostic tool to detect small bowel mucosal pathology. However, it has been infrequently used to evaluate bowel inflammation in spondylarthropathies. This study compared the accuracy of videocapsule endoscopy to standard ileocolonoscopy for the detection of inflammatory bowel lesions in patients with spondylarthropathies, and to describe the clinical and laboratory predictors of small bowel inflammation in this cohort.
NCT03064815 — Crohn Disease
Status: Completed
http://inclinicaltrials.com/crohn-disease/NCT03064815/
A Phase III, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren™ (Natalizumab) in Crohn's Disease Subjects Who Have Previously Participated in Antegren Crohn's Disease Studies
The primary objective of this study is to evaluate the long-term tolerability and safety of natalizumab when administered a dose of 300 mg intravenously (IV) to subjects with Crohn's Disease who have previously participated in studies CD251, CD301, CD303, CD306, or CD307.
NCT00280956 — Crohn's Disease
Status: Completed
http://inclinicaltrials.com/crohn-s-disease/NCT00280956/
The Clinical Outcomes of Patients With Stricturing Crohn's Diseases Received Biologics: a Prospective, Observative Study
Recent researches have reported that biologics might be also effective for stricturing CD. However, the data were largely retrospective. Prospective studied are needed for evaluate the efficacy of biologics for stricturing Crohn's diseases.
NCT05645055 — The Efficacy of Biologics for Stricturing Crohn's Diseases
Status: Recruiting
http://inclinicaltrials.com/the-efficacy-of-biologics-for-stricturing-crohn-s-diseases/NCT05645055/
Significance and Outcome of Magnetic Resonance Enterography Revealing Sacroiliitis in Crohn's Disease: A Pilot Study
This study aims to further define and characterize imaging findings of possible sacroiliitis in Crohn's Disease patients by recalling subjects who had findings of possible sacroiliitis on prior MRE and assess the natural history and outcome of these cases by using standard magnetic resonance imaging (MRI) and x-ray of the sacroiliac joints.
NCT05203926 — Sacroiliitis
Status: Enrolling by invitation
http://inclinicaltrials.com/sacroiliitis/NCT05203926/
Effect of Small Bowel Crohn's Disease on Chylomicron Secretion After Ingestion of a Fatty Meal
It is often suggested that lymphatic vessels are ineffective in transporting cargo in Crohn's disease. Our own work on surgically resected tissue supports this concept (1), but the concept has not been directly tested. Chylomicrons are packaged lipids from the diet with an obligatory absorption route through the lymphatic vasculature to reach host plasma. This protocol takes an approach to directly quantify chylomicron secretion using a fatty meal that incorporates stable isotopic tracers for trioleate and cholesterol in the meal. We will collect baseline plasma and then plasma every 30 minutes for 6 hours to chart the kinetic and magnitude of chylomicron secretion and transport in all subjects using mass spectrometry analysis. We will characterize a wide variety of parameters on the chylomicrons as well using ELISA. Infusions i.v. of stable isotope labeled triglyceride and glycerol will allow us to consider whether there are changes in VLDL metabolism that could account for differences in chylomicron handling once the chylomicrons are secreted into plasma. Collection and analysis of breath samples will also be carried to normalize against possible incomplete lipid absorption in some subjects.
NCT03496818 — Crohn Disease
Status: Completed
http://inclinicaltrials.com/crohn-disease/NCT03496818/
The Biologic Onset of Crohn's Disease: A Screening Study in First Degree Relatives
Pursuing very early diagnosis is standard of care for several diseases including colon cancer, diabetes and liver disease where an early and aggressive diagnostic and therapeutic approach has been shown to change their natural history. Crohn's disease [CD] still lags since commonly at presentation CD has already run a long course, often responding poorly to therapy or requiring surgery. This innovative project proposes a minimally invasive strategy - capsule endoscopy-based screening of first degree relatives [FDR's] of CD patients - to develop tools to diagnose CD at or near its biologic onset.
NCT03291743 — Crohn Disease
Status: Terminated
http://inclinicaltrials.com/crohn-disease/NCT03291743/
Prospective Study of Predictive Factors of Sustained Remission of Crohn's Disease After Stopping Infliximab
1 Project summary 1.1 Rational. Accent 1 study has demonstrated the superiority of Infliximab over placebo in a systematic treatment strategy of Crohn 's disease every 8 weeks during one year. However the optimal strategy beyond one year of treatment is not established. Particularly, the need for carrying on systematic treatment with infliximab in all the patients has not been demonstrated. 1.2 Primary objective. Determine factors associated with a low risk of clinical relapse after stopping infliximab in CD patients in remission (CDAI<150) and regularly treated with infliximab for at least one year. 1.3 Main objective and main judgement criteria. Determine predictive factors for relapse within one year after stopping infliximab. Main judgement criteria is the clinical relapse after stopping infliximab. Clinical relapse is defined either by a CDAI>250 or by a CDAI between 150 and 250 if this CDAI is confirmed over two consecutive weeks with an increase of at least 70 points over baseline for the two consecutive measures. 1.4 Secondary objectives and judgement criteria. Determine the time to-relapse Determine predictive factors for short-term relapse (<2 months)after stopping infliximab. Determine response to infliximab retreatment in these patients. Determine tolerance to infliximab retreatment in these patients. Determine predictive factors for an absence of response to retreatment. Determine predictive factors for infliximab retreatment intolerance. Determine sustained response in the retreated patients. 1.5 Type of study Open-label prospective study of stopping regular treatment. Inclusion period: minimum one year, possibly prolonged to reach 100 patients. Patients will be followed up every two months for at least 18 months after stopping infliximab. 1.6 Justification of the number of patients Number of patients to include is at least 100. This recruitment should be reached within one year. This number should allow to disclose predictive factors associated with a relative risk of at least 2 if this factor is equilibrated (50% at risk patients) or 3 is this factor is disequilibrated (90% at risk patients).
NCT00571337 — Crohn Disease
Status: Completed
http://inclinicaltrials.com/crohn-disease/NCT00571337/
Surgical Intervention Versus Biologics Treatment for Symptomatic Stricturing Crohn's Disease (SIBTC): an Open-label, Single-center, Randomized Controlled Trial
The management of stricturing Crohn's disease (CD) remains challenging. Although surgical resection may be the final way to solve it, the efficacy of biologics for symptomatic CD associated strictures was acceptable. In clinical practice, the chioce of treatment is particularly difficult. Therefore, a clinical trial of biologics versus surgery is needed to assess which one is prefered.
NCT05421455 — Crohn Disease
Status: Recruiting
http://inclinicaltrials.com/crohn-disease/NCT05421455/
MeSenteric SpAring Versus High Ligation Ileocolic Resection for the Prevention of REcurrent Crohn's DiseaSe (SPARES)
Study description - Patients will be randomized according to post-operative recurrence risk to either a high ligation of ileocolic artery or mesenteric sparing ileocolic resection for terminal ileal Crohn's disease. The primary endpoint 6-month endoscopic recurrence. Endpoints - Primary endpoint; 6 months Secondary endpoints at 1 and 5 years post ileocecal resection Study population - Adult Crohn's disease patients with medically refractory terminal ileal Crohn's disease undergoing a primary ileocecal resection. Study sites - Multicenter international study Description of study intervention - Randomized control trial of two operative techniques Operative approach of a high ligation of ileocolic artery as compared to mesenteric sparing for a primary ileocolic resection Participate duration - 5 years
NCT04578392 — Crohn Disease
Status: Recruiting
http://inclinicaltrials.com/crohn-disease/NCT04578392/
A Phase III, Randomized, Double-blind Trial in the Comparison of Cimzia Versus Cimzia Plus Azathioprine in the Change in Mean SES-CD (Simple Endoscopic Scores-Crohn's Disease) Scores in the Treatment of Active, Moderate to Severe Crohn's Disease
This is a randomized, double blind trial of combination therapy (Cimzia plus Azathioprine) versus mono therapy (Cimzia alone) and the improvement in mean SES-CD (Simple Endoscopic Scoring in Crohn's Disease) score. It is a trial where the investigators are administering biological therapy by itself and biological therapy plus an immunosuppressive medicine in combination to see which form of therapy has a better effect on healing ulcerations in the small intestine and colon that are due to a flare up of Crohn's disease.
NCT01817972 — Crohn's Disease
Status: Not yet recruiting
http://inclinicaltrials.com/crohn-s-disease/NCT01817972/