World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 22 February 2021
Main ID:  NCT02764762
Date of registration: 05/05/2016
Prospective Registration: Yes
Primary sponsor: Takeda
Public title: Triple Combination Therapy in High Risk Crohn's Disease (CD)
Scientific title: An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing Complications
Date of first enrolment: June 12, 2017
Target sample size: 55
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT02764762
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Canada United States
Contacts
Name:     Medical Director Clinical Science
Address: 
Telephone:
Email:
Affiliation:  Takeda
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Has an initial diagnosis of CD established within 24 months prior to screening with
involvement of the ileum and/or colon that can be assessed by ileocolonoscopy.

2. Has moderate to severely active CD during Screening defined by a centrally assessed
SES-CD score >=7 (or >=4 if isolated ileal disease).

Exclusion Criteria:

Gastrointestinal (GI) Exclusion Criteria

1. Has a diagnosis of ulcerative colitis (UC) or indeterminate colitis.

2. Has clinical evidence of a current abdominal abscess or a history of prior abdominal
abscess.

3. Has a known perianal fistula with abscess. (The participant may have a perianal
fistula without abscess.)

4. Has a known fistula (other than perianal fistula).



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn Disease
Intervention(s)
Drug: Adalimumab
Drug: Methotrexate
Drug: Vedolizumab
Primary Outcome(s)
Percentage of Participants Achieving Endoscopic Remission at Week 26 [Time Frame: Week 26]
Secondary Outcome(s)
Change From Baseline in C-reactive Protein (CRP) Levels at Weeks 10 and 26 [Time Frame: Baseline, Weeks 10 and 26]
Change From Baseline in Fecal Calprotectin Concentrations at Weeks 10, 14, 26, 52, 78, and 102 [Time Frame: Baseline, Weeks 10, 14, 26, 52, 78 and 102]
Change From Baseline in SES-CD Score at Week 26 [Time Frame: Baseline and Week 26]
Percentage of Participants Achieving Clinical Remission and CRP <5 Milligram per Liter (mg/L) at Weeks 26, 52, 78, and 102 [Time Frame: Weeks 26, 52, 78 and 102]
Percentage of Participants Achieving Clinical Remission and Endoscopic Response as a Measure of Mucosal Healing at Week 26 [Time Frame: Week 26]
Percentage of Participants Achieving Clinical Remission at Weeks 10 and 26 [Time Frame: Weeks 10 and 26]
Percentage of Participants Achieving Clinical Response at Weeks 10 and 26 [Time Frame: Weeks 10 and 26]
Percentage of Participants Achieving Deep Remission at Week 26 [Time Frame: Week 26]
Percentage of Participants Achieving Endoscopic Healing at Week 26 [Time Frame: Week 26]
Percentage of Participants Achieving Endoscopic Response at Week 26 [Time Frame: Week 26]
Percentage of Participants Maintaining Clinical Remission and Endoscopic Response as a Measure of Mucosal Healing at Week 102 [Time Frame: Week 102]
Percentage of Participants Maintaining Clinical Remission at Weeks 52, 78, and 102 [Time Frame: Weeks 52, 78 and 102]
Percentage of Participants Maintaining Deep Remission at Week 102 [Time Frame: Week 102]
Percentage of Participants Maintaining Endoscopic Healing at Week 102 [Time Frame: Week 102]
Percentage of Participants Maintaining Endoscopic Remission at Week 102 [Time Frame: Week 102]
Percentage of Participants Maintaining Endoscopic Response at Week 102 [Time Frame: Week 102]
Percentage of Participants Using Oral Corticosteroids at Baseline who Have Discontinued Corticosteroids and are in Clinical Remission at Weeks 10, 26, and 102 [Time Frame: Weeks 10, 26 and 102]
Percentage of Participants with First Exacerbation of CD [Time Frame: After 26 Weeks up to Week 128]
Secondary ID(s)
U1111-1175-9094
Vedolizumab-4006
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history