Clinical trials: Crohn Disease and Ulcerative Colitis
Crohn Disease, Ulcerative Colitis
National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life
National, prospective, multicentre observational study designed for eligible patients treated with Inflectra. Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the…
- Conditions
- Crohn Disease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis
- Trial name
- ReFLECT (NCT02925338)
- Testing
- QOL questionaire
- Where
- 67 sites in France
- Volunteers
- 1,431 people
- Sponsor
- Pfizer
Colitis, Ulcerative, Crohn Disease
A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice
The purpose of this study is to characterize the treatment patterns associated with biologics agents use or non-biological therapy in participants with moderate to severe Ulcerative Colitis (UC) and Crohn's Disease (CD).
- Conditions
- Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
- Trial name
- INTENT (NCT03532932)
- Where
- 36 sites in Belarus, Kazakhstan and 1 more
- Volunteers
- 1,990 people
- Sponsor
- Takeda
Colitis, Ulcerative, Crohn's Disease
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 (UC) and Crohn's disease (CD).
- Trial name
- NCT02620046
- Testing
- Vedolizumab SC
- Where
- 301 sites in United States, Argentina and 31 more
- Volunteers
- 746 people
- Sponsor
- Takeda
Inflammatory Bowel Diseases, Ulcerative Colitis
Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's Colitis
The primary aims of this phase I/II, randomized, placebo controlled study are the assessment of safety and tolerability of universal donor FMT compared to placebo in pediatric and young adult subjects (ages 5 years through 30…
- Conditions
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- Trial name
- NCT02330653
- Testing
- Fecal Microbiota Transplant (FMT)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Stacy A. Kahn
Ulcerative Colitis, Crohn's Disease
An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease
The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.
- Trial name
- GEMINI LTS (NCT00790933)
- Testing
- Vedolizumab
- Where
- 41 sites in United States, Australia and 8 more
- Volunteers
- 2,243 people
- Sponsor
- Takeda
Ulcerative Colitis, Crohn's Disease
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…
- Trial name
- NCT03650413
- Testing
- UTTR1147A
- Where
- 57 sites in United States, Bulgaria and 12 more
- Volunteers
- 143 people
- Sponsor
- Genentech, Inc.
Inflammatory Bowel Diseases, Clostridium Difficile Infection
ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI
This is a randomized controlled trial to assess the clinical and microbiological impacts of FMT in combination with Bezlotoxumab (bezlo) compared to FMT in combination with placebo in patients with both inflammatory bowel disease…
- Trial name
- ICON-2 (NCT03829475)
- Testing
- Bezlotoxumab, Fecal Microbiota Transplantation
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Brigham and Women's Hospital
Inflammatory Bowel Diseases, Colitis, Ulcerative
Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes
The purpose of this study is to determine if a relationship exists between Week 6 vedolizumab therapeutic drug monitoring (TDM) and Week 30 Faecal calprotectin (FCP).
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
- Trial name
- VEDO TDM RWE (NCT04567628)
- Testing
- No Intervention
- Where
- Canada
- Volunteers
- 7,873 people
- Sponsor
- Takeda
Crohn Disease, Colitis, Ulcerative
A Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Quality of Life in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD)
The purpose of this study is to evaluate the percentage of moderate to severe IBD participants with active disease at Day 1.
- Conditions
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Disease
- Trial name
- RISE AR (NCT03488030)
- Where
- 7 sites in Argentina
- Volunteers
- 246 people
- Sponsor
- Takeda
Ulcerative Colitis, Crohn Disease
A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, people with ulcerative colitis or Crohn's disease will be treated with vedolizumab.
- Trial name
- NCT04804540
- Testing
- Vedolizumab IV
- Where
- 17 sites in India
- Volunteers
- 150 people
- Sponsor
- Takeda
Colitis, Ulcerative, Crohn's Disease
Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease
The purpose of this study is to assess the concentration of vedolizumab in breast milk of lactating women with active ulcerative colitis (UC) or Crohn's disease (CD) who are receiving vedolizumab therapeutically.
- Trial name
- NCT02559713
- Testing
- Vedolizumab
- Where
- 7 sites in United States
- Volunteers
- 11 people
- Sponsor
- Takeda
Venous Thromboses, Venous Thromboembolism
The Risk of Venous Thromboembolism in Systemic Inflammatory Disorders: a United Kingdom (UK) Matched Cohort Study
Blood clots occurring in the legs and in the lungs are relatively common; they occur in around 3 in a 1000 people per year. They can cause disability and are also potentially life threatening.
- Conditions
- Venous Thromboses, Venous Thromboembolism, Deep Vein Thrombosis, Pulmonary Embolism
- Trial name
- NCT03835780
- Testing
- No intervention
- Where
- United Kingdom
- Volunteers
- 266,890 people, healthy volunteers welcome
- Sponsor
- Momentum Data
Crohn Disease, Colitis, Ulcerative
A Study to Test the Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
The primary objective is to characterize the efficacy TEV-48574 in adult participants with IBD (moderate to severe Ulcerative Colitis (UC) or Crohn's Disease (CD)) as assessed by induction of clinical remission (UC) and…
- Trial name
- RELIEVE UCCD (NCT05499130)
- Testing
- TEV-48574
- Where
- 164 sites in United States, Austria and 17 more
- Volunteers
- 290 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Crohn Disease, Ulcerative Colitis
Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis
This is a Phase 1b, open-label, dose-escalation, signal-finding, multi-center study. The study will evaluate the safety, tolerability, pharmacokinetics and short-term efficacy of MDGN-002 in adults with moderate to severe, active…
- Trial name
- NCT03169894
- Testing
- MDGN-002
- Where
- 13 sites in United States
- Volunteers
- 8 people
- Sponsor
- Avalo Therapeutics, Inc.
Ulcerative Colitis, Crohn's Disease
Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active UC or CD.
- Trial name
- NCT03138655
- Testing
- Vedolizumab
- Where
- 88 sites in United States, Belgium and 9 more
- Volunteers
- 89 people
- Sponsor
- Takeda
Inflammatory Bowel Diseases
Safety and Tolerability Of Allogeneic Mesenchymal Stromal Cells in Pediatric Inflammatory Bowel Disease
In this trial, investigators will infuse donor bone marrow mesenchymal stromal cells intravenously, as a treatment for pediatric Crohn's disease or ulcerative colitis that has not responded to conventional therapies.
- Trial name
- NCT02150551
- Testing
- Allogeneic bone marrow-derived mesenchymal stromal cells
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Catherine Bollard
Inflammatory Bowel Disease, Crohn's Disease
Vitamin D Levels in Children With IBD
Research has shown that children with Inflammatory Bowel Disease may have lower levels of vitamin D than healthy children, especially in the winter.
- Conditions
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
- Trial name
- NCT00621257
- Testing
- ergocalciferol, Cholecalciferol
- Where
- United States
- Volunteers
- 134 people
- Sponsor
- Boston Children's Hospital
Ulcerative Colitis, Crohn's Disease
Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease
This was an open-label study to provide an opportunity for participants with Ulcerative Colitis (UC) who previously completed Study C13002 (NCT01177228), and for treatment-naïve participants with UC or Crohn's Disease (CD) to…
- Trial name
- NCT00619489
- Testing
- vedolizumab
- Where
- Canada
- Volunteers
- 72 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Inflammatory Bowel Diseases, Ulcerative Colitis
Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel Disease (IBD).
The study will compare the effectiveness of Bezlotoxumab in individuals with active C. diff ( Clostridium difficile) infection who are diagnosed with Inflammatory Bowel Disease.
- Conditions
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease, C. Diff. Infections
- Trial name
- NCT04626947
- Testing
- Bezlotoxumab
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- David Binion, MD
Crohn Disease, Ulcerative Colitis
A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis
The purpose of this study is to evaluate the long-term safety and efficacy of Deucravacitinib in participants who have previously been enrolled in a Deucravacitinib Phase 2 study for moderate to severe Crohn's disease or moderate…
- Trial name
- NCT04877990
- Testing
- Deucravacitinib
- Where
- 43 sites in United States, Australia and 14 more
- Volunteers
- 67 people
- Sponsor
- Bristol-Myers Squibb