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94 active trials for Crohn's Disease

A proSpective Randomized Controlled Trial comParing infliximAb-antimetabolites Combination Therapy to Anti-metabolites monotheRapy and Infliximab monothErapy in Crohn's Disease Patients in Sustained Steroid-free Remission on Combination Therapy

Phase IV Design : Prospective, open-label, randomized three-arms study Main Inclusion criteria Luminal Crohn's disease patients with steroid free remission for at least 6 months and a combination therapy with infliximab and anti-metabolites for at least 8 months Primary objective To demonstrate that Infliximab scheduled maintenance with or without antimetabolites is superior to antimetabolites alone to maintain sustained steroid-free remission over 2 years, while the latter is non inferior with regards to the mean time spent in remission over the same duration Main co-primary end points Clinical relapse rate at 2 years Mean remission duration within 2 years Study treatment Infliximab, Mercaptopurine, azathioprine, methotrexate. Number of subjects 225 randomized patients (75 per arm) Study duration: 3 + 2 years Enrollment: 3 years Follow-up: 2 years

Start: October 2015

A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in Real-World Practice

Vedolizumab is a medicine that helps to reduce symptoms of IBD and the associated inflammation in the digestive system for participants with ulcerative colitis or Crohn's disease. In this study, participants with ulcerative colitis or Crohn's disease will be treated with vedolizumab according to their clinic's standard practice. Participants will receive vedolizumab as either an infusion or an injection just under the skin (subcutaneous). The main aim of the study is to observe real-world treatment patterns in participants treated with vedolizumab. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study.

Start: July 2021

A Study Evaluating the Efficacy and Safety of Oral Etrasimod in the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

This is a Phase 2/3 study that comprises 5 substudies designed to evaluate the efficacy, safety, and tolerability of oral etrasimod as therapy in adult participants with moderately to severely active Crohn's disease (CD) who are refractory or intolerant to at least 1 of the current therapies for CD (ie, corticosteroids, immunosuppressants, or biologics). The overall duration of this study is up to 282 weeks, inclusive of the 28-Day Screening Period, Treatment Period of up to 274 weeks (Induction, Extension or Maintenance, and Long-term Extension Periods), and the 4-Week Follow-Up Period for safety assessment.

Start: February 2020

Postauthorization Safety Study of Darvadstrocel Repeat Administration

The purpose of this study is to evaluate the long-term safety and efficacy of repeat administration of darvadstrocel in participants with Crohn's Disease (CD) and complex perianal fistula by evaluation of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and special situation reports (SSRs).

Start: December 2020

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease

The study consists of 4 sub-studies, as follows: Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991; Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991; Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab; Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab.

Start: April 2018

A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.

Start: July 2019

A Trial of Yoga in Pediatric Inflammatory Bowel Disease

IBD adds additional stressors as a chronic disease that has unpredictable and sometimes embarrassing symptoms to the normal challenges that teenagers face. Stress and how stressful events are perceived, may contribute to worsening of disease. Complementary and alternative medicine (CAM), are used often by pediatric IBD patients and maybe beneficial in decreasing stress and improving quality of life. Yoga could be a well suited paring with standard medical therapy to decrease and provide a better sense of control and improve quality of life.

Start: December 2017

A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease

TARGET-IBD is a 5-year, longitudinal, observational study of adult and pediatric patients (age 2 and above) being managed for Inflammatory Bowel Disease (IBD) in usual clinical practice. TARGET-IBD will create a research registry of patients with IBD within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

Start: July 2017

A Safety Extension Study of Ontamalimab in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA)

The purpose of this study is to evaluate the safety and tolerability of long-term treatment with ontamalimab in participants with moderate to severe Ulcerative Colitis (UC) or Crohn's disease (CD).

Start: February 2018

A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.

Start: June 2020

A Study of Darvadstrocel for Treating Complex Perianal Fistulas in Children and Teenagers With Crohn's Disease

A perianal fistula is an abnormal passageway that develops between the rectum and the skin near the anus. The fistula is considered complex if it branches into several openings or an abscess is also present. The main aim of this study is to learn if complex perianal fistulas in children and teenagers close after treatment with darvadstrocel. 2 to 3 weeks before treatment with darvadstrocel, each participant will have surgery to clean the fistula and to drain any abscesses. On the day of treatment, each participant will have the fistula cleaned and will receive an injection of darvadstrocel near the fistula, under anesthetic. For up to 1 year after treatment, participants will regularly visit the clinic for follow-up. The fistula will be examined and any side effects from the treatment will be recorded. Participants will have an MRI at one clinic visit (about 24 weeks after treatment).

Start: June 2021

Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)

The purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).

Start: February 2019

Improving the Quality of Care for Adults With Inflammatory Bowel Disease

Innovative programs exist that suggest that care for people with chronic conditions is optimized when patients and providers have the information they need at the point of care and over time, to engage in shared planning and execution of treatment goals and care plans. This project aims to build an Inflammatory Bowel Disease Learning Health System, a shared information environment, that highlights collaboration among patients, clinicians and care team members, and researchers; for effective use of data for guiding care, value, improvement, and research.

Start: February 2016

A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease

The main aim of the study is to check for long-term side effects of Vedolizumab Subcutaneous (also known as Vedolizumab SC) in people with ulcerative colitis and Crohn's disease. Vedolizumab SC will be given as an injection just under the skin. This type of injection is called a subcutaneous injection or SC for short. Another aim of the study is to collect information on whether the participant's condition remains under control or improves during and after treatment with Vedolizumab SC. Participants who previously took part in studies MLN0002SC-3027 or MLN002SC-3031 will be invited to visit the study clinic. At this visit, the study doctor will check if each participant can take part in this study. For those who can take part, participants will receive a subcutaneous injection of vedolizumab SC either once a week or once every 2 weeks. How often each participant receives vedolizumab SC will depend on their results from the previous study and on how active their condition is. Participants might be able to self-inject vedolizumab SC after being trained by the study doctors. During this study, the dose of vedolizumab SC might be increased for participants whose condition worsens. Participants will continue treatment with vedolizumab SC until it is approved in their particular country, the participant decides to stop treatment, or the sponsor stops the study. If the sponsor stops the study before vedolizumab SC is approved in all countries, the sponsor will make sure all affected participants will have access to vedolizumab SC outside of the study. After their final dose of vedolizumab SC, participants will visit the clinic 18 weeks later for a final check-up. Then, the clinic will telephone the participants 6 months after their final dose of vedolizumab SC to check if they have any health problems.

Start: April 2016

A Study of the Efficacy and Safety of Upadacitnib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

Start: December 2017

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).

Start: November 2017

An Investigational Study of Experimental Medication BMS-986165 in Participants With Moderate to Severe Crohn's Disease

The purpose of this study is to assess the safety and effectiveness of BMS-986165 compared to placebo in participants with moderately to severely active Crohn's Disease.

Start: July 2018

A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)

The purpose of the study is to assess systemic certolizumab pegol (CZP) exposure, the formation of anti-CZP antibodies and safety of CZP across the course of pregnancy in study participants with chronic inflammatory diseases.

Start: June 2020

Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced. Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Gilead Study GS-US-419-3896).

Start: October 2016

An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease

This study will evaluate the long-term safety and tolerability of UTTR1147A in participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD), enrolling up to 320 participants from the parent studies: Phase Ib Study GA29469 (NCT02749630) and Phase II Study GA39925 (NCT03558152).

Start: January 2019