Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.


Clinical Trial Description

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis. This study will look at the stool frequency, rectal bleeding and findings on endoscopy of people who take vedolizumab compared to those who take adalimumab.

The study will enroll approximately 658 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

- Vedolizumab 300 mg IV

- Adalimumab 160 mg on Day 1 followed by 80 mg on Week 2 then 40 mg every 2 weeks SC

All participants will receive 1 intravenous infusion on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. All participants will also receive 4 SC injections on Day 1 or 2 SC injections each on Days 1 and 2, followed by 2 SC injections in 1 day on Week 2 and then 1 SC injection every 2 weeks for up to Week 50. All participants will be asked to record the symptoms of ulcerative colitis in a daily diary.

This multi-center trial will be conducted worldwide. The overall time to participate in this study is 79 weeks. Participants will make approximately 11 visits to the clinic, and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02497469
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 3
Start date June 29, 2015
Completion date January 18, 2019

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04989907 - A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
Completed NCT03494764 - Hyperbaric Oxygen Therapy for Ulcerative Colitis Flares Phase 2
Recruiting NCT03937609 - TITRATE (inducTIon for acuTe ulceRATivE Colitis) Phase 4
Completed NCT00503243 - Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis Phase 3
Completed NCT03606499 - Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
Completed NCT02537210 - Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis N/A
Active, not recruiting NCT02316678 - Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics N/A
Completed NCT00488631 - An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis Phase 3
Completed NCT00928681 - A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis Phase 1
Recruiting NCT05242484 - A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis Phase 2
Completed NCT01036022 - Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis Phase 2
Recruiting NCT03841045 - Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases
Active, not recruiting NCT05528510 - A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis Phase 3
Completed NCT02825914 - CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM) N/A
Recruiting NCT06049017 - A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis Phase 2
Completed NCT04567628 - Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes
Withdrawn NCT05999708 - A First Time in Human Study to Evaluate the Safety and Tolerability of GSK4381406 in Healthy Participants Phase 1
Recruiting NCT05611671 - A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC Phase 2
Active, not recruiting NCT03596645 - A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis Phase 3
Completed NCT03648541 - BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis Phase 2