Crohn's Disease Clinical Trial
Official title:
An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With Moderately to Severely Active Crohn's Disease Treated With Vedolizumab IV
The purpose of this study is to evaluate endoscopic remission at Week 26 as assessed by ileocolonoscopy.
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to
treat people who have Crohn's disease. This study will look at mucosal healing in people who
take vedolizumab.
The study will enroll approximately 100 patients and will be conducted in 2 Parts. Part A
will consist of a 26-week treatment period and all participants will receive vedolizumab 300
mg intravenously (IV) on Day 1 and at Weeks 2, 6, 14 and 22. Part B will consist of a 26-week
extension treatment period and all participants will receive vedolizumab 300 mg IV at Weeks
30, 38, and 46.
This multi-center trial will be conducted worldwide. The overall time to participate in this
study is approximately 70 weeks for Parts A, B and 18-Week Follow-up combined. Participants
will make multiple visits to the clinic. All participants included in the study will also
have a 6 month safety follow-up telephone call following his/her last dose of study drug.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03815851 -
Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery
|
N/A | |
| Not yet recruiting |
NCT06100289 -
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
|
Phase 3 | |
| Completed |
NCT02883452 -
A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis
|
Phase 1 | |
| Recruiting |
NCT04777656 -
Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.
|
Phase 3 | |
| Terminated |
NCT03017014 -
A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
|
||
| Recruiting |
NCT06053424 -
Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease
|
Phase 1 | |
| Recruiting |
NCT05428345 -
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
|
||
| Completed |
NCT02508012 -
Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases
|
N/A | |
| Terminated |
NCT02882841 -
MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients
|
N/A | |
| Not yet recruiting |
NCT02858557 -
The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
|
N/A | |
| Terminated |
NCT02417974 -
Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
|
Phase 2 | |
| Completed |
NCT03010787 -
A First Time in Human Study in Healthy Volunteers and Patients
|
Phase 1 | |
| Completed |
NCT02542917 -
Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
|
||
| Active, not recruiting |
NCT02316678 -
Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics
|
N/A | |
| Completed |
NCT02154425 -
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
|
Phase 1 | |
| Completed |
NCT02265588 -
Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD).
|
N/A | |
| Completed |
NCT02197780 -
Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD
|
N/A | |
| Completed |
NCT02193048 -
Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
|
||
| Recruiting |
NCT02395354 -
Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease
|
N/A | |
| Completed |
NCT01951326 -
Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease
|
Phase 3 |