MLN0002-3026 Vedolizumab vs Adalimumab in Ulcerative Colitis
Research type
Research Study
Full title
A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis
IRAS ID
189127
Contact name
John McLaughlin
Contact email
Sponsor organisation
Takeda Development Centre Europe, Ltd
Eudract number
2015-000939-33
Duration of Study in the UK
1 years, 11 months, 3 days
Research summary
The main purpose of this research study is to assess the efficacy and safety of vedolizumab (administered via intravenous infusion) compared to adalimumab (administered via subcutaneous injection).
Vedolizumab (also called Entyvio®) is approved for the treatment of adult patients with moderately to severely active UC or Crohn’s Disease (CD) who have failed conventional treatment, (eg, immunomodulators (which supress the immune system), corticosteroids (anti-inflammatories), or tumour necrosis factor-alpha (TNF-α) antagonists (targets TNF alpha to reduce inflammation) in several regions, including the United States (US) and European Union (EU). The use of vedolizumab in this study is investigational.
This study will look at the effect vedolizumab has on UC by viewing the gut using various methods - clinical evaluation, flexible sigmoidoscopy (an examination that views the inside of the colon and rectum using a tool called a colonoscope) and through looking at changes in the cells of the intestine (referred to as histology). Participants will also be asked to record how often they empty their bowels and whether there is any blood in the stool.
This study will also assess the safety of vedolizumab and will use a specifically designed questionnaire to examine the impact that UC may have on the participant’s quality of life.
The study includes a 3 week screening period, a 52-week treatment period and an 18-week follow-up period following the last dose at Week 50. Participants will need to visit the clinic approximately 12 times for the study over a 71-week period (depending on the scheduling of study procedures).
All patients who participate in the study will also be included in a safety follow-up phone survey six months following the last dose.REC name
North West - Haydock Research Ethics Committee
REC reference
15/NW/0786
Date of REC Opinion
21 Oct 2015
REC opinion
Favourable Opinion