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Crohn Disease clinical trials

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NCT ID: NCT05784129 Terminated - Crohn's Disease Clinical Trials

A Study of Guselkumab for the Treatment of Participants With Crohn's Disease After Surgical Resection

PROGRESS
Start date: February 21, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of guselkumab treatment compared with placebo (an inactive substance with no medicine) in preventing recurrence of Crohn's disease in participants after surgery.

NCT ID: NCT05579444 Terminated - Obesity Clinical Trials

Systems Biology of Gastrointestinal and Related Diseases

Start date: November 11, 2022
Phase:
Study type: Observational

This is a longitudinal observational study on patients with gastrointestinal and related disease. The study will be conducted for at least 10 years, following each participant over time, as they either go through relapses and remissions, or progression of their disease.

NCT ID: NCT05474742 Terminated - Ulcerative Colitis Clinical Trials

The Nori Health App

Start date: April 25, 2022
Phase: N/A
Study type: Interventional

A multicenter, randomized controlled trial with an embedded pilot and qualitative component to investigate the effects of the Nori Health app.

NCT ID: NCT05068284 Terminated - Crohn's Disease Clinical Trials

A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's Disease

AIM-CD
Start date: January 31, 2022
Phase: Phase 2
Study type: Interventional

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active CD. Adverse events and change in the disease activity will be assessed. ABBV-154 is an investigational drug being evaluated for the treatment of CD. In the induction period, there is a 1 in 5 chance that participants will be assigned to placebo. Depending on the dose received in the induction period, there is a 1 in 2 or 1 in 3 chance that participants will be assigned to placebo in the maintenance period. Around 265 participants 18-75 years of age with moderately to severely active CD will be enrolled in the study at approximately 200 sites worldwide. The study is compromised of a 12-week double-blind, placebo-controlled induction period, followed by either a 12-week double-blind re-induction period for non-responders or a 40-week double-blind placebo-controlled maintenance period for responders. In the maintenance period, responders will be randomized to receive subcutaneous placebo or ABBV-154 in 2 different doses every other week. Participants in the placebo group who are initial responders will receive ABBV-154 in the maintenance period. There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05013385 Terminated - Clinical trials for Fibrostenotic Crohn´s Disease

A Study to Test Whether Spesolimab Helps People With Crohn's Disease Who Have Symptoms of Bowel Obstruction

Start date: November 9, 2021
Phase: Phase 2
Study type: Interventional

This study is open to adults, between 18 and 75 years of age, who have narrowings in the small bowel (strictures) due to Crohn's disease. Strictures can lead to bowel obstruction (blockage). People whose symptoms got worse because of strictures can join the study. Participants get standard treatment for Crohn's disease and the strictures. The purpose of the study is to test whether the strictures improve further when treated with a medicine called spesolimab added to standard treatment. Participants are in the study for about 1 year and 4 months. In the first 3 months, participants get standard treatment only. After 3 months, participants whose condition improved are put into 2 groups randomly, which means by chance. One group gets spesolimab added to their standard treatment. The other group gets placebo added to their standard treatment. Both spesolimab and placebo are given as infusions into a vein. Placebo infusions look like spesolimab infusions but do not contain any medicine. For the first 2 months, participants get the infusions every month. Thereafter, participants get the infusions every 2 months. During the study, participants have about 11 visits to the study site. The doctors regularly check participants' health and take note of any unwanted effects. At 3 of the visits, doctors take images of the bowel using Magnetic Resonance Imaging and with an endoscope. At these visits, the doctors also take a small sample of bowel tissue (biopsy). The participants note their symptoms of Crohn's disease and how the symptoms affect daily life in an electronic diary. At the end of the study, results from the diaries and bowel imaging are compared between the spesolimab group and the placebo group.

NCT ID: NCT04995783 Terminated - Clinical trials for Rheumatoid Arthritis

Predicting Medication Response for Autoimmune Disease

REEF
Start date: September 1, 2020
Phase:
Study type: Observational

Coral is conducting a large study comparing and predicting the relative effectiveness of different medications for autoimmune patients. Patients with Inflammatory Bowel Disease (IBD) who have been diagnosed with either Ulcerative Colitis or Crohn's Disease and are undergoing treatment are eligible to participate. Patients with Rheumatoid Arthritis (RA) and Psoriasis (Ps) will also be enrolled. A novel clinical test will be performed to predict the responsiveness of a particular patient to different immune modulating therapies used in these conditions.

NCT ID: NCT04881370 Terminated - Ulcerative Colitis Clinical Trials

Quality of Life for Patients With Chronic Paediatric Onset Inflammatory Bowel Disease (IBD)

QALY-ECOPED
Start date: October 9, 2020
Phase:
Study type: Observational

The main objective of the present study is to describe the quality of life of patients under 25 years of age with pediatric-onset IBD. The quality of life will be described according to the age and the activity of the disease in order to make it possible to associate with the different states of health a measure of quality of life (utility score) from utility values established in the French context. These data are essential for the realization of medico-economic models.

NCT ID: NCT04804046 Terminated - Crohn's Disease Clinical Trials

Synbiotics and Post-op Crohn's Disease

Start date: July 15, 2021
Phase: N/A
Study type: Interventional

Crohn's disease (CD) is a lifelong incurable condition that causes inflammation of the intestinal tract of humans. The exact cause of CD is unknown, but genetics, diet, and the gut microbiome are all thought to play a major role. Many patients with CD will require surgery to remove affected portions of the gut, with ileocecal resections being the most common procedure performed. Regrettably, there is up to an 85% chance that disease returns to the surgical site. Strong immune suppressive medications may help to prevent disease relapse. However, patients are then at risk of serious side effects. Currently, no ideal post-op care exists for CD patients. This study aims to assess whether a post-op synbiotic therapy (i.e. probiotics plus dietary fiber) prevents disease relapse in participants with CD. To test this, participants will consume probiotics (strains of bifidobacteria) before their surgery and then probiotics plus fiber supplements after surgery. Probiotics are live bacteria that have been shown to reduce inflammation of the gut. Fiber is given after surgery to help promote beneficial bacterial taxa and prevent less favorable bacterial taxa from triggering CD relapse. Patients will take the supplements for 6 months following surgery. They will be seen monthly to assess the effects of treatment on quality of life, symptoms of disease recurrence, inflammatory markers, and the gut microbiome. All patients will also undergo a colonoscopy at the end of the study to check for endoscopic reoccurrence.

NCT ID: NCT04629196 Terminated - Crohn Disease Clinical Trials

Induction Optimization With Stelara for Crohn's Disease

Start date: February 16, 2022
Phase: Phase 4
Study type: Interventional

This is a 16-week randomized controlled trial comparing a second IV weight-based induction dose at week 8 to standard 90mg subcutaneous dose at week 8, with a primary endpoint of clinical remission at week 16.

NCT ID: NCT04362254 Terminated - Crohn Disease Clinical Trials

A Study to Test Long-term Treatment With Spesolimab in Patients With Fistulising Crohn's Disease Who Took Part in Previous Trials

Start date: May 15, 2020
Phase: Phase 2
Study type: Interventional

The main objectives of this study are to evaluate the long-term safety of spesolimab in patients with perianal fistulising Crohn's disease who have completed treatment in parent trials and to evaluate the long-term efficacy of spesolimab in patients with perianal fistulising Crohn's disease, who have completed treatment in parent trials