Clinical trials: Inflammatory Bowel System
Ulcerative Colitis
A Prospective Non-interventional Multicenter Study to Evaluate the Effectiveness of Adalimumab in Korean Patients With Ulcerative Colitis (UC) and Identify Potential Predictors of Clinical Response in Routine Clinical Practice
This is a prospective, single country, multi-center study in participants with ulcerative colitis (UC) treated with adalimumab. Up to 147 participants are enrolled at approximately 20 sites.
- Trial name
- EUREKA (NCT02499263)
- Where
- 19 sites in South Korea
- Volunteers
- 150 people
- Sponsor
- AbbVie
Crohn's Disease, Ulcerative Colitis
Assessing the Drug Exposure Risk of Infants Breastfed by Women With Inflammatory Bowel Disease
Breastfeeding is beneficial to both mother and baby. However, many breastfeeding women are affected by long-term health conditions and need to take medications.
- Conditions
- Crohn's Disease, Ulcerative Colitis, Healthy Controls
- Trial name
- NCT03397108
- Testing
- The IBD group was divided into 2 subgroups: with or without anti-TNF antibody use
- Where
- 2 sites in Canada
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Ulcerative Colitis
Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels
The purpose of this study is to gain insight into the exposure-response relationship of golimumab in moderate-to-severe Ulcerative Colitis (UC).
- Trial name
- GO-LEVEL (NCT03124121)
- Testing
- Golimumab
- Where
- United Kingdom
- Volunteers
- 112 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Colitis, Ulcerative
A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors
This Phase III, randomized, double-blind, parallel-grouped, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in participants with moderately to severely…
- Trial name
- LAUREL (NCT02165215)
- Testing
- Etrolizumab
- Where
- 104 sites in United States, Brazil and 13 more
- Volunteers
- 359 people
- Sponsor
- Hoffmann-La Roche
Gastric Ulcer, Duodenal Ulcer
Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID
The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily…
- Conditions
- Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis
- Trial name
- NCT00542789
- Testing
- Esomeprazole
- Where
- 39 sites in Japan
- Volunteers
- 343 people
- Sponsor
- AstraZeneca
Ulcerative Colitis
A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the efficacy and safety of adalimumab in Japanese subjects with moderately to severely active ulcerative colitis (UC).
- Trial name
- NCT00853099
- Testing
- adalimumab
- Where
- 65 sites in Japan
- Volunteers
- 274 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
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
Crohn's Disease
Long-term Safety Study of Brodalumab in Adults With Crohn's Disease
The purpose of this study is to evaluate the safety and efficacy of long-term treatment with brodalumab in adults with Crohn's disease.
- Trial name
- NCT01199302
- Testing
- Brodalumab
- Where
- 34 sites in United States, Australia and 6 more
- Volunteers
- 67 people
- Sponsor
- Amgen
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
Colitis, Ulcerative
Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis
The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response and if there are related changes in…
- Trial name
- NCT01953354
- Testing
- Trichuris suis ova (TSO)
- Where
- 17 sites in United States
- Volunteers
- 16 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Colitis, Ulcerative, Crohn Disease
A Study to Determine the Pharmacokinetics (PK) of Single Intravenous (IV) Dose of Vedolizumab 300 Milligram (mg) in Healthy Adult Chinese Participants
The purpose of this study is to assess the PK of vedolizumab following a single intravenous infusion in healthy adult Chinese participants.
- Trial name
- NCT03329209
- Testing
- Vedolizumab
- Where
- China
- Volunteers
- 16 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
Crohn's Disease, Inflammatory Bowel Disease
An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
This study will assess the safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who already participated and completed the core trial CAIN457A2202.
- Trial name
- NCT01009281
- Testing
- AIN457
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Novartis Pharmaceuticals
Crohn's Disease
Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease
This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in…
- Trial name
- NCT02038920
- Testing
- Vedolizumab
- Where
- 56 sites in Japan
- Volunteers
- 157 people
- Sponsor
- Takeda
Sepsis, Necrotising Enterocolitis Neonatal
Integrated Predictive Monitoring for Sepsis and Necrotizing Enterocolitis
Behind the scenes pilot trial in the computer lab involving chart review to use neonatal intensive care unit data to create computer models predicting sepsis and necrotizing enterocolitis in very small premature infants
- Trial name
- PREMO (K) (NCT07254559)
- Testing
- No Intervention: Observational Cohort
- Where
- United States
- Volunteers
- 144 people
- Sponsor
- University of Virginia
Crohn's Disease
Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's Disease
This study will assess the safety and efficacy of AIN457 in patients with moderate to severe active Crohn's disease.
- Trial name
- NCT00584740
- Testing
- AIN457
- Where
- 2 sites in Germany
- Volunteers
- 59 people
- Sponsor
- Novartis Pharmaceuticals
Crohn's Disease
Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
The purpose of this study is to evaluate the safety of adalimumab for treatment of patients with moderate to severe Crohn's Disease (CD) and to measure the effects of treatment on patient general well-being, health-related…
- Trial name
- NCT00409617
- Testing
- adalimumab
- Where
- 189 sites in Austria, Belgium and 15 more
- Volunteers
- 945 people
- Sponsor
- Abbott
Ulcerative Colitis
Evaluation of 3D Visualization for Total Colectomy
The anticipated advantages of 3D laparoscopic visualization for the surgeon are greater accuracy and speed in manual skills, translating to decreased operative time, reduced learning curve, and superior safety.We aimed to…
- Trial name
- 3Dvs2DforUC (NCT02370056)
- Testing
- 3-dimensional visualization, 2-dimensional visualization
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- The Cleveland Clinic
Inflammatory Bowel Diseases
Biomarkers of Anti-TNF Treatment in Inflammatory Bowel Disease (IBD)
Anti-TNF treatment (infliximab (IFX), adalimumab (ADA)) has become standard therapy for refractory pediatric and adult Crohn's disease (CD) patients, and is used for the induction (primary response) and maintenance of remission.
- Trial name
- NCT01971970
- Testing
- Infliximab, Adalimumab
- Where
- Netherlands
- Volunteers
- 45 people
- Sponsor
- Erasmus Medical Center
Inflammatory Bowel Disease
The Pediatric Intermed: A New Clinical Decision Making Tool
The investigators have recently developed a paediatric adaptation of the INTERMED tool to address the unique developmental and social contexts of children and youth.
- Trial name
- NCT01781481
- Where
- Canada
- Volunteers
- 148 people
- Sponsor
- Children's Hospital of Eastern Ontario