A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433
A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.
NCT03345823 — Crohn's Disease
Status: Active, not recruiting
http://inclinicaltrials.com/crohn-s-disease/NCT03345823/
Prospective Study to Evaluate the Role of Shear-Wave Elastography in Predicting the Degree of Intestinal Fibrosis in Patients With Crohn's Disease Who Are Candidates for Surgery - ElChir Study
The choice of the optimal timing for surgery in Crohn's disease is a challenging issue and diagnostic tools able to estimate the degree of fibrosis are of great interest in this context. Indeed, inflammatory intestinal loops are more likely to respond to medical therapies, wheareas fibrotic loops need to be treated surgically. Shear-wave elastography, which is a non-invasive and largely available technique for the study of tissue elasticity, is very promising and a recent meta-analysis has evaluated its diagnostic accuracy vs histologic examination in patients with stenosing Crohn's disease, showing encouraging results. Aim of this study is to evaluate the diagnostic agreement between elastographic parameters (mean, median, stability index) and the degree of intestinal fibrosis evaluated on the surgical specimen.
NCT06056986 — Crohn Disease
Status: Recruiting
http://inclinicaltrials.com/crohn-disease/NCT06056986/
A Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive
A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.
NCT01453946 — Crohn's Disease
Status: Completed
http://inclinicaltrials.com/crohn-s-disease/NCT01453946/
Crohn's Disease European Registry. A Prospective, Observational, Postmarketing Safety Surveillance Registry of Patients Treated With Remicade® or Standard Therapy
Prospective, observational, parallel-group, postmarketing safety surveillance registry in participants treated with Remicade or standard therapy for active or fistulizing Crohn's disease (CD). The follow-up period is up to 5 years. The participants in the standard therapy group may switch over to Remicade any time during the follow-up period
NCT00705614 — Crohn's Disease
Status: Completed
http://inclinicaltrials.com/crohn-s-disease/NCT00705614/
A Phase IIa, Open Label, Single-centre Study to Assess the Initial Antifibrotic Efficacy, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of MBF-118 in Crohn's Disease Patients With Stenosis
This is a Phase IIa (proof of concept), single center clinical trial to evaluate the safety and efficacy of daily MBF-118 oral treatment during 28 days in Crohn's disease patients on top of standard of care.
NCT05940558 — Crohn Disease
Status: Recruiting
http://inclinicaltrials.com/crohn-disease/NCT05940558/
Autologous Adipose-derived Stem Cells (ASCs) for the Treatment of Perianal Fistula in Crohn Disease: A Pilot Study
Crohn's disease is an immunologically mediated inflammatory bowel disease with a reported incidence of 4.0-7.0, 7.1, and 1.34 per 100,000 persons in Europe, the U.S., and Korea, respectively. Uncontrolled chronic inflammation finally causes various complications in intestine such as bowel obstruction, fistulas, abscesses, and anal fissures. The incidence of perianal fistula was reported in 13%- 39% of patients with Crohn's disease. Medical treatment for Crohn's fistulae initially focused on surgical intervention accompanied by symptomatic treatment with antibiotics and immunosuppressants. The most serious problem after surgical intervention is the relatively high incidence of postoperative anal incontinence caused by sphincter injury during the procedure. Conversely, available pharmacological therapies for Crohn's fistulae based on biologic agents such as infliximab do not generally reach ideal goal of treatment (e.g., complete closure of the fistula). A high recurrence rate after treatment with infliximab has also been reported, even after long-term maintenance therapy, which suggests that infliximab monotherapy does not provide adequate healing. The ACCENT II study demonstraded a complete fistula healing in 25% of patients. To reach a better clinical outcome, combination treatment with infliximab and surgical intervention is highly recommended for management of Crohn's fistulae. Nonetheless, even this strategy does not result in a satisfactory healing for many patients. The ideal therapeutic goal of treatment is not only complete closure of the fistula without recurrence but also preservation of anal sphincter function. Unfortunately, currently available medical or surgical treatment is not likely to offer a cure for perianal fistulae and, as noted above, recurrence is frequently reported. Together with active research in the field of bone marrow-derived mesenchymal stem cells (BM-MSCs) and hematopoietic stem cells, autologous or allogenic adipose tissue-derived stem cells (ASCs) have been studied for management of Crohn's disease and other disorders. Of particular relevance to this study, ASCs could be considered to be safe and efficacious therapeutic tools for the treatment of Crohn's fistulae. Importantly, ASCs do not cause fecal incontinence after injection into the lesion site in Crohn's disease patients. A phase I dose-escalation clinical study with ASCs manufactured by Anterogen Co., Ltd. (Seoul, Korea) demonstrated the safety and therapeutic potential of these cells for the treatment of Crohn's fistulae. A phase II study demonstrated a good rate of cronh's related fistula closure using a ASCS injection. Actually the best accepted treatment of Crohn related perianal fistula, is the surgical procedure in association whit medical therapy.
NCT02403232 — Crohn Disease
Status: Recruiting
http://inclinicaltrials.com/crohn-disease/NCT02403232/
A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Re-exposure After a Variable Interval and Subsequent Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed at Weeks 0, 2 and 4 Then Every 4 Weeks), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohn's Disease.
A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn from the double-blind study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] due to an exacerbation of Crohn's Disease.
NCT00160706 — Crohn's Disease
Status: Completed
http://inclinicaltrials.com/crohn-s-disease/NCT00160706/
RISE: A Remote Study of Insomnia Treatment in Crohn's Disease
The purpose of this study is to assess whether the investigators can treat insomnia in people with Crohn's disease, and if insomnia treatment can make other things better, like pain or inflammation.
NCT05956158 — Insomnia
Status: Recruiting
http://inclinicaltrials.com/insomnia/NCT05956158/
Randomized Intervention Study of Mindfulness-Based Stress-Reduction to Improve the Quality of Life and Immune Regulation in Patients With Crohn's Disease
A randomized controlled study which aims to improve the quality of life of Crohn's disease adult patients suffering from mild to moderate level of symptoms. Patients will be randomized to Intervention or Wait-List groups and will undergo eight Cognitive Behavioral and Mindfulness, one on one, sessions with a social worker via SkypeTM. The Intervention group will receive intervention upon recruitment while the Wait-List group will receive the same intervention after 3 months. Clinical, biological and psycho-social data will be collected at four time points over the 12-months of the study.
NCT05085925 — Crohn's Disease Colon
Status: Completed
http://inclinicaltrials.com/crohn-s-disease-colon/NCT05085925/
A Pilot Trial of CBT-I for Sleep, Pain, and Inflammation in Crohn's Disease
People with Crohn's disease often suffer from sleep problems. Long term, sleep problems may lead to more flares of Crohn's disease or other complications. In general, people with Crohn's disease also report that sleep problems can worsen symptoms of Crohn's disease the next day. In people with other medical problems, research has also shown that having sleep problems can make other things worse, such as pain and inflammation. In this study, the researchers want to understand the treatment of sleep problems in people with Crohn's disease, and what else might improve if sleep gets better. This study will use Cognitive Behavioral Therapy for Insomnia (CBT-I) to treat insomnia symptoms. CBT-I is the recommended treatment for insomnia and has been shown to improve sleep problems, pain, and inflammation in other groups of people. If this study is successful, it will contribute to understanding how to treat insomnia in people with Crohn's disease and how sleep impacts pain and inflammation. Long term, this information will be helpful in understanding how best to take care of people with Crohn's disease.
NCT05034159 — Pain
Status: Completed
http://inclinicaltrials.com/pain/NCT05034159/