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Triple Combination Therapy in High Risk Crohn's Disease (CD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02764762
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date  ICMJE May 5, 2016
First Posted Date  ICMJE May 6, 2016
Last Update Posted Date February 17, 2020
Actual Study Start Date  ICMJE June 12, 2017
Estimated Primary Completion Date September 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
Percentage of Participants Achieving Endoscopic Remission at Week 26 [ Time Frame: Week 26 ]
Endoscopic remission is defined as simple endoscopic score for Crohn's Disease (SES-CD) scale score from 0-2. The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2016)
Percentage of Participants Achieving Endoscopic Remission at Week 26 [ Time Frame: Week 26 ]
Endoscopic remission is defined as simple endoscopic score for Crohn's Disease (SES-CD) scale score from 0-2. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
  • Percentage of Participants Achieving Endoscopic Healing at Week 26 [ Time Frame: Week 26 ]
    Endoscopic healing is defined as SES-CD score less than or equal to (<=) 4 and reduction from Baseline in SES-CD score of at least 2 points and no individual SES-CD subscore greater than (>) 1. The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Percentage of Participants Achieving Endoscopic Response at Week 26 [ Time Frame: Week 26 ]
    Endoscopic response is defined as 50% reduction in SES-CD score from Baseline. The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Change From Baseline in SES-CD Score at Week 26 [ Time Frame: Baseline and Week 26 ]
    The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Percentage of Participants Achieving Deep Remission at Week 26 [ Time Frame: Week 26 ]
    Deep remission is defined as Crohn's disease activity index (CDAI) score less than (<) 150 and SES-CD score from 0-2. CDAI is scoring system for the assessment of CD activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease. The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Percentage of Participants Achieving Clinical Remission and Endoscopic Response as a Measure of Mucosal Healing at Week 26 [ Time Frame: Week 26 ]
    Clinical remission is defined as CDAI score <150. Endoscopic response defined as 50% reduction in SES-CD score from Baseline, as mucosal healing. CDAI is scoring system for assessment of CD activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease. The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The SES-CD total is sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Percentage of Participants Achieving Clinical Remission at Weeks 10 and 26 [ Time Frame: Weeks 10 and 26 ]
    Clinical remission is defined as CDAI score <150. CDAI is scoring system for the assessment of CD activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
  • Percentage of Participants Achieving Clinical Response at Weeks 10 and 26 [ Time Frame: Weeks 10 and 26 ]
    Clinical response is defined as greater than or equal to (>=) 100-point decrease in CDAI score. CDAI is scoring system for the assessment of CD activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
  • Change From Baseline in C-reactive Protein (CRP) Levels at Weeks 10 and 26 [ Time Frame: Baseline, Weeks 10 and 26 ]
    The change between the CRP levels collected at Weeks 10 and 26 relative to Baseline.
  • 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 ]
    The change between the fecal calprotectin concentrations collected at Weeks 10, 14, 26, 52, 78, and 102 relative to Baseline.
  • 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 ]
    Clinical remission is defined as CDAI score <150 and CRP level <5 mg/L in participants with elevated CRP level at Baseline. CDAI is scoring system for the assessment of CD activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
  • 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 using oral corticosteroids at Baseline who have discontinued corticosteroids and are in clinical remission at weeks 10, 26, and 102 will be reported. Clinical remission is defined as CDAI score <150. CDAI is scoring system for the assessment of CD activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
  • Percentage of Participants Maintaining Clinical Remission at Weeks 52, 78, and 102 [ Time Frame: Weeks 52, 78 and 102 ]
    Clinical remission is defined as CDAI score <150. Clinical remission is defined as CDAI score <150. CDAI is scoring system for the assessment of CD activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
  • Percentage of Participants Maintaining Endoscopic Remission at Week 102 [ Time Frame: Week 102 ]
    Endoscopic remission is defined as SES-CD score 0-2. The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Percentage of Participants Maintaining Deep Remission at Week 102 [ Time Frame: Week 102 ]
    Deep remission is defined as CDAI score <150 and SES-CD score 0-2. Clinical remission is defined as CDAI score <150. CDAI is scoring system for the assessment of CD activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease. The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Percentage of Participants Maintaining Endoscopic Healing at Week 102 [ Time Frame: Week 102 ]
    Endoscopic healing is defined as SES-CD score <=4 and reduction from Baseline in SES-CD score of at least 2 points and no individual SES-CD subscore >1. The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Percentage of Participants Maintaining Endoscopic Response at Week 102 [ Time Frame: Week 102 ]
    Endoscopic response is defined as 50% reduction in SES-CD score from Baseline. The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Percentage of Participants Maintaining Clinical Remission and Endoscopic Response as a Measure of Mucosal Healing at Week 102 [ Time Frame: Week 102 ]
    Clinical remission is defined as CDAI score <150. Endoscopic response defined as 50% reduction in SES-CD score from Baseline, as mucosal healing. CDAI is scoring system for assessment of CD activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease. The SES-CD evaluates 4 endoscopic variables (ulcer size, percentage of the surface area that is ulcerated, percentage of the surface area affected, and stenosis in 5 colonic segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The SES-CD total is sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Percentage of Participants with First Exacerbation of CD [ Time Frame: After 26 Weeks up to Week 128 ]
    First exacerbation of CD after 26 weeks is defined as either: 1) a CDAI increase of >70 from the prior visit on 2 occasions separated by a 2-week interval, objective evidence of disease activity by colonoscopy or CRP above normal OR 2) fecal calprotectin >250 microgram per gram (mcg/g) alone. Clinical remission is defined as CDAI score <150. CDAI is scoring system for the assessment of CD activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2016)
  • Percentage of Participants Achieving Endoscopic Healing at Week 26 [ Time Frame: Week 26 ]
    Endoscopic healing is defined as SES-CD score ≤4 and reduction from baseline in SES-CD score of at least 2 points and no individual SES-CD subscore >1. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Percentage of Participants Achieving Endoscopic Response at Week 26 [ Time Frame: Week 26 ]
    Endoscopic response is defined as 50% reduction in SES-CD score from baseline. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Change From Baseline in SES-CD Score at Week 26 [ Time Frame: Baseline and Week 26 ]
    The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Percentage of Participants Achieving Deep Remission at Week 26 [ Time Frame: Week 26 ]
    Deep remission is defined as Crohn's disease activity index (CDAI) score<150 and SES-CD score from 0-2. CDAI is scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Percentage of Participants Achieving Clinical Remission and Endoscopic Response as a Measure of Mucosal Healing at Week 26 [ Time Frame: Week 26 ]
    Clinical remission is defined as CDAI score <150. Endoscopic response defined as 50% reduction in SES-CD score from baseline, as mucosal healing. CDAI is scoring system for assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The SES-CD total is sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Percentage of Participants Achieving Clinical Remission at Weeks 10 and 26 [ Time Frame: Weeks 10 and 26 ]
    Clinical remission is defined as CDAI score <150. CDAI is scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
  • Percentage of Participants Achieving Clinical Response at Weeks 10 and 26 [ Time Frame: Weeks 10 and 26 ]
    Clinical response is defined as ≥100-point decrease in CDAI score. CDAI is scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
  • Change From Baseline in C-reactive Protein (CRP) Levels at Weeks 10 and 26 [ Time Frame: Baseline, Weeks 10 and 26 ]
    The change between the CRP levels collected at Weeks 10 and 26 relative to Baseline.
  • Change From Baseline in Fecal Calprotectin Concentrations at Weeks 10, 26, 52, 78, and 102 [ Time Frame: Baseline, Weeks 10, 26, 52, 78 and 102 ]
    The change between the fecal calprotectin concentrations collected at Weeks 10, 26, 52, 78, and 102 relative to Baseline.
  • Percentage of Participants Achieving Clinical Remission and CRP <5 mg/L at Weeks 26, 52, 78, and 102 [ Time Frame: Weeks 26, 52, 78 and 102 ]
    Clinical remission is defined as CDAI score <150 and CRP level <5 mg/L in participants with elevated CRP level at Baseline. CDAI is scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
  • 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 using oral corticosteroids at Baseline who have discontinued corticosteroids and are in clinical remission at weeks 10, 26, and 102 will be reported. Clinical remission is defined as CDAI score <150. CDAI is scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
  • Percentage of Participants Maintaining Clinical Remission at Weeks 52, 78, and 102 [ Time Frame: Weeks 52, 78 and 102 ]
    Clinical remission is defined as CDAI score <150. Clinical remission is defined as CDAI score <150. CDAI is scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
  • Percentage of Participants Maintaining Endoscopic Remission at Week 102 [ Time Frame: Week 102 ]
    Endoscopic remission is defined as SES-CD score 0-2. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Percentage of Participants Maintaining Deep Remission at Week 102 [ Time Frame: Week 102 ]
    Deep remission is defined as CDAI score <150 and SES-CD score 0-2. Clinical remission is defined as CDAI score <150. CDAI is scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Percentage of Participants Maintaining Endoscopic Healing at Week 102 [ Time Frame: Week 102 ]
    Endoscopic healing is defined as SES-CD score ≤4 and reduction from baseline in SES-CD score of at least 2 points and no individual SES-CD subscore >1. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Percentage of Participants Maintaining Endoscopic Response at Week 102 [ Time Frame: Week 102 ]
    Endoscopic response is defined as 50% reduction in SES-CD score from baseline. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Percentage of Participants Maintaining Clinical Remission and Endoscopic Response as a Measure of Mucosal Healing at Week 102 [ Time Frame: Week 102 ]
    Clinical remission is defined as CDAI score <150. Endoscopic response defined as 50% reduction in SES-CD score from baseline, as mucosal healing. CDAI is scoring system for assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The SES-CD total is sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
  • Percentage of Participants with First Exacerbation of Crohn's disease (CD) [ Time Frame: After 26 Weeks up to Week 128 ]
    First exacerbation of CD is defined as a CDAI increase of >70 from the prior visit on 2 occasions separated by a 2-week interval, objective evidence of disease activity by colonoscopy or CRP above normal or fecal calprotectin >250 μg/gm. Clinical remission is defined as CDAI score <150. CDAI is scoring system for the assessment of Crohn's Disease Activity, index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Triple Combination Therapy in High Risk Crohn's Disease (CD)
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine the effect of triple combination therapy with an anti-integrin (vedolizumab intravenous [IV]), a tumor necrosis factor (TNF) antagonist (adalimumab subcutaneously [SC]), and an immunomodulator (oral methotrexate) on endoscopic remission in participants with newly-diagnosed CD stratified at higher risk for complications.
Detailed Description

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have CD. This study will look at the endoscopic remission and mucosal healing of gastrointestinal tract of people who take vedolizumab as triple combination therapy with adalimumab and methotrexate.

The study will enroll approximately 60 participants. Participants will receive triple combination therapy which includes:

  • Vedolizumab 300 mg (intravenous)
  • Adalimumab 160/80/40 mg (subcutaneous)
  • Methotrexate 15 mg (Oral)

All participants will receive vedolizumab intravenous infusion on Weeks 0, 2, 6, 14 and 22 along with adalimumab 160 mg, subcutaneous injection at Week 0, 80 mg at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with methotrexate tablets orally, once weekly from Weeks 0 up to Week 34. In monotherapy phase, all participants will receive vedolizumab intravenous infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102.

This multi-center trial will be conducted in the United States and Canada. The overall time to participate in this study is 128 weeks. Participants will make multiple visits to the clinic, plus a final visit 18 weeks after last dose of study drug for a safety follow-up assessment. Participants will also participate in a long-term safety questionnaire, by phone, at 26 weeks (6 months) from the last dose of study drug.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn Disease
Intervention  ICMJE
  • Drug: Vedolizumab
    Vedolizumab intravenous infusion.
    Other Names:
    • Entyvio
    • MLN0002 IV
  • Drug: Adalimumab
    Adalimumab injection for subcutaneous use.
    Other Name: Humira
  • Drug: Methotrexate
    Methotrexate oral tablets.
Study Arms  ICMJE Experimental: Vedolizumab 300 mg+Adalimumab 160-40 mg+Methotrexate 15 mg
In Triple Combination Therapy Phase, vedolizumab 300 milligram (mg), intravenous infusion, once at Weeks 0, 2, 6, 14 and 22, along with adalimumab 160 mg subcutaneously, once at Week 0, then 80 mg once at Week 2, then 40 mg once at Week 4 and every 2 weeks thereafter until Week 26 along with oral Methotrexate 15 mg tablets orally once weekly from Weeks 0 up to Week 34. In Monotherapy Phase, vedolizumab 300 mg intravenous infusion once at Weeks 30, 38, 46, 54, 62, 70, 78, 86, 94 and 102.
Interventions:
  • Drug: Vedolizumab
  • Drug: Adalimumab
  • Drug: Methotrexate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 13, 2022
Estimated Primary Completion Date September 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02764762
Other Study ID Numbers  ICMJE Vedolizumab-4006
U1111-1175-9094 ( Registry Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Clinical Science Takeda
PRS Account Takeda
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP