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Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease (GEMINI II)

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
vedolizumab
Placebo
Sponsored by
Millennium Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18 to 80
  2. Diagnosis of moderately to severely active Crohn's disease (CD)
  3. CD involvement of the ileum and/or colon

  4. Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents, within protocol-specified parameters:

    1. Immunomodulators
    2. Tumor necrosis factor-alpha (TNFα) antagonists
    3. Corticosteroids
  5. May be receiving a therapeutic dose of conventional therapies for irritable bowel disease (IBD) defined by the protocol

Exclusion Criteria

  1. Evidence of abdominal abscess at the initial screening visit, other than a minimum of 10 aphthous ulcerations involving a minimum of 10 contiguous cm of intestine
  2. Extensive colonic resection, subtotal or total colectomy
  3. History of >3 small bowel resections or diagnosis of short bowel syndrome
  4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
  5. Have received non permitted IBD therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
  6. Chronic hepatitis B or C infection
  7. Active or latent tuberculosis

Sites / Locations

  • University of Alabama at Birmingham
  • Apex Clinical Trials
  • Gastrointestinal Bioscience
  • Paramount Medical Specialty
  • Capital Gastroenterology Consultants Medical Group
  • Clinical Applications Laboratories Inc.
  • Desta Digestive Disease Medical Center
  • University of Colorado Health Sciences Center
  • Rocky Mountain Clinical Research, LLC
  • Gastroenterology of the Rockies
  • Arapahoe Gastroenterology Associates P.C.
  • South Denver Gastroenterology
  • Lynn Institute of Pueblo
  • Connecticut Gastroenterology Institute
  • Gastroenterology Center of Connecticut, P.C.
  • University of Florida
  • University of Florida, Jacksonville
  • East Coast Institute for Research
  • Borland-Groover Clinic
  • Center for Advanced Gastroenterology
  • Osler Clinical Research
  • University of Miami Miller School of Medicine
  • United Medical Research Institute
  • Compass Research LLC
  • Internal Medicine Specialists
  • University of South Florida
  • West Wind'r Research & Development, LLC
  • Shafran Gastroenterology Center
  • Atlanta Gastroenterology Associates
  • Southeast Regional Research Group
  • Atlanta Center for Gastroenterology, P.C.
  • Gastroenterology Associates of Central Georgia
  • Digestive Research Associates
  • St. Joseph's/Candler Health System
  • DLW Research System
  • Rush University Medical Center
  • University of Chicago Medical Center
  • Carle Clinic Association P.C.
  • Indianapolis Gastroenterology & Hepatology, Inc.- ARC
  • Digestive & Liver Consultants
  • Iowa Digestive Disease Center
  • University Of Kansas
  • Cotton O'Neil Digestive Health Center
  • University of Kentucky Medical Center
  • University Of Louisville
  • Gastroenterology Associates
  • Metropolitan Gastroenterology Group, P.C.
  • Shah Associates
  • Massachusetts General Hospital
  • Boston Medical Center
  • The Center for Clinical Studies
  • Center for Digestive Health
  • Gastroenterology Associates of Western Michigan, P.L.C.
  • Minnesota Gastroenterology, P.A.
  • Mayo Clinic
  • Digestive Health Specialists
  • Truman Medical Center
  • Center for Digestive and Liver Diseases, Inc.
  • Washington University
  • St. Louis Center for Clinical Research
  • Dartmouth-Hitchcock Medical Center
  • Affiliates in Gastroenterology PA
  • University of Medicine and Dentistry of New Jersey-NJMS
  • The Gastroenterology Group of South Jersey
  • Hepatobiliary Associates of New York
  • Digestive Health Physician
  • Long Island Clinical Research Associates
  • Long Island Gastroenterology Group, P.C.
  • New York Presbyterian Hospital
  • Present Chapman Marion Steinlauf MD PC
  • Kim, Chung MD (Private Practice)
  • University of Rochester
  • Long Island Digestive Disease Consultants
  • SUNY Stony Brook University Medical Center
  • Syracuse Gastroenterological Associates
  • Asheville Gastroenterology Associates, P.A.
  • University of North Carolina at Chapel Hill
  • Charlotte Gastroentology and Hepatology, P.L.L.C
  • Northwest Piedmont Clinical Research, Inc.
  • Burke Research Associates
  • Wake Forest University Baptist Medical Center
  • Consultants for Clinical Research Inc.
  • Cleveland Clinic Foundation
  • Dayton Science Institute
  • Options Health Research
  • The Oregon Clinic-West Hills Gastroenterology
  • University of Pittsburgh Medical Center - Cancer Centers
  • Medical University Of SC CAR
  • Consultants in Gastroenterology
  • Gastroenterology Center of the MidSouth, PC
  • Vanderbilt University Medical Center
  • Austin Gastroenterology, PA
  • Bayou City Research, Ltd.
  • Gastroenterology Consultants
  • Jacon Medical Research Associates
  • Digestive Health Center
  • Alamo Medical Research
  • Gastroenterology Clinic of San Antonio
  • Stone Oak Research Foundation
  • Digestive Health Specialists of Tyler
  • Granite Peaks Gastroenterology
  • University of Virginia Health System
  • Gastroenterology Associates of Northern Virginia
  • Digestive and Liver Disease Specialist Ltd.
  • Hunter Holmes McGuire VA Medical Center
  • Northwest Gastroenterology Associates
  • Puget Sound Medical Research
  • Pharmaseek, LLC
  • Wisconsin Center for Advanced Research
  • Medical College Of Wisconsin
  • GI Research
  • Zeidler Ledcor Center-Univerisity of Alberta
  • Royal University Hospital
  • Pharmaseek, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vedolizumab

Placebo

Arm Description

In the Induction Phase participants received vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 (Days 1 and 15). In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria were randomized in a 1:1:1 ratio to double-blind treatment with vedolizumab administered every 4 weeks, vedolizumab administered every 8 weeks, or placebo for up to Week 50. Participants who did not demonstrate response at Week 6 of the Induction Phase continued treatment with vedolizumab, administered every 4 weeks during the Maintenance Phase.

In the Induction Phase participants received placebo intravenous infusion at Week 0 and Week 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction.

Outcomes

Primary Outcome Measures

Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: Number of liquid or soft stools each day for 7 days; Abdominal pain (graded from 0-3 on severity) each day for 7 days; General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; Presence of complications; Taking Lomotil or opiates for diarrhea; Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); Hematocrit of < 0.47 in men and < 0.42 in women; Percentage deviation from standard weight. The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6
Enhanced clinical response is defined as a CDAI score at least 100 points lower than Baseline. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: Number of liquid or soft stools each day for 7 days; Abdominal pain (graded from 0-3 on severity) each day for 7 days; General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; Presence of complications; Taking Lomotil or opiates for diarrhea; Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); Hematocrit of < 0.47 in men and < 0.42 in women; Percentage deviation from standard weight. The total score ranges from 0 to 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response.
Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52
Clinical remission is defined as a CDAI score ≤ 150. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: Number of liquid or soft stools each day for 7 days; Abdominal pain (graded from 0-3 on severity) each day for 7 days; General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; Presence of complications; Taking Lomotil or opiates for diarrhea; Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); Hematocrit of < 0.47 in men and < 0.42 in women; Percentage deviation from standard weight. The total score ranges from 0 to 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.

Secondary Outcome Measures

Induction Phase: Change From Baseline in C-Reactive Protein (CRP) Levels at Week 6
C-reactive protein (CRP) is a protein found in the blood, the levels of which rise in response to inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age. Higher levels indicate mild inflammation (10-40 mg/L) and active inflammation (40-200 mg/L).
Maintenance Phase: Percentage of Participants With Enhanced Clinical Response at Week 52
Enhanced clinical response is defined as a CDAI score at least 100 points lower than the Baseline value. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: Number of liquid or soft stools each day for 7 days; Abdominal pain (graded from 0-3 on severity) each day for 7 days; General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; Presence of complications; Taking Lomotil or opiates for diarrhea; Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); Hematocrit of < 0.47 in men and < 0.42 in women; Percentage deviation from standard weight. The total score ranges from 0 to 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response.
Maintenance Phase: Percentage of Participants in Corticosteroid-free Clinical Remission at Week 52
Participants using oral corticosteroids at Baseline, who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 52 achieved corticosteroid-free clinical remission. The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free clinical remission.
Maintenance Phase: Percentage of Participants With Durable Clinical Remission
Durable clinical remission is defined as CDAI score ≤ 150 points at 80% or more of study visits during the Maintenance Phase, including the Week 52 visit (11 of 13 study visits). The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission

Full Information

First Posted
October 31, 2008
Last Updated
June 19, 2014
Sponsor
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00783692
Brief Title
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease
Acronym
GEMINI II
Official Title
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Millennium Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response and remission at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.
Detailed Description
Study C13007 comprised 2 randomized, double-blind, placebo-controlled studies conducted under 1 protocol which, operationally, consisted of 2 phases. The Induction Phase, designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and clinical remission, and The Maintenance Phase, designed to establish the efficacy and safety of vedolizumab for the maintenance of clinical response and clinical remission. The 6-week Induction Phase contained 2 cohorts of participants: Cohort 1 participants were randomized and treated with double-blind study drug, and Cohort 2 participants were treated with open-label vedolizumab. The second cohort was enrolled to ensure that the sample size of Induction Phase responders randomized into the Maintenance Study provided sufficient power for the Maintenance Study primary efficacy analysis. These participants did not contribute to the efficacy analyses performed for the Induction Study. Participants in both cohorts were assessed for treatment response at Week 6. In the Maintenance Phase vedolizumab-treated participants from both Cohort 1 and Cohort 2 who demonstrated a clinical response were randomized in a 1:1:1 ratio to double-blind treatment with vedolizumab administered every 4 weeks (Q4W), vedolizumab administered every 8 weeks (Q8W), or placebo. Vedolizumab-treated participants who did not demonstrate response at Week 6 continued treatment with open-label vedolizumab, administered Q4W. Participants treated with double-blind placebo in the Induction Phase continued on double-blind placebo during the Maintenance Phase, regardless of treatment response during induction. The Maintenance Phase began at Week 6 and concluded with Week 52 assessments. After the Week 52 assessments, participants may have been eligible to enroll in Study C13008 (NCT00790933; Long-term Safety Study) to receive open-label vedolizumab treatment. Participants who withdrew early (prior to Week 52) due to sustained nonresponse, disease worsening, or the need for rescue medications may have been eligible to enroll in Study C13008. Participants who did not enroll into Study C13008 were to complete a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose) in the Maintenance Phase of Study C13007.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vedolizumab
Arm Type
Experimental
Arm Description
In the Induction Phase participants received vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 (Days 1 and 15). In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria were randomized in a 1:1:1 ratio to double-blind treatment with vedolizumab administered every 4 weeks, vedolizumab administered every 8 weeks, or placebo for up to Week 50. Participants who did not demonstrate response at Week 6 of the Induction Phase continued treatment with vedolizumab, administered every 4 weeks during the Maintenance Phase.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
In the Induction Phase participants received placebo intravenous infusion at Week 0 and Week 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction.
Intervention Type
Drug
Intervention Name(s)
vedolizumab
Other Intervention Name(s)
Entyvio, MLN0002, MLN02, LDP-02
Intervention Description
Vedolizumab for intravenous infusion
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo intravenous infusion
Primary Outcome Measure Information:
Title
Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6
Description
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: Number of liquid or soft stools each day for 7 days; Abdominal pain (graded from 0-3 on severity) each day for 7 days; General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; Presence of complications; Taking Lomotil or opiates for diarrhea; Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); Hematocrit of < 0.47 in men and < 0.42 in women; Percentage deviation from standard weight. The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Time Frame
Week 6
Title
Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6
Description
Enhanced clinical response is defined as a CDAI score at least 100 points lower than Baseline. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: Number of liquid or soft stools each day for 7 days; Abdominal pain (graded from 0-3 on severity) each day for 7 days; General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; Presence of complications; Taking Lomotil or opiates for diarrhea; Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); Hematocrit of < 0.47 in men and < 0.42 in women; Percentage deviation from standard weight. The total score ranges from 0 to 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response.
Time Frame
Baseline and Week 6
Title
Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52
Description
Clinical remission is defined as a CDAI score ≤ 150. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: Number of liquid or soft stools each day for 7 days; Abdominal pain (graded from 0-3 on severity) each day for 7 days; General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; Presence of complications; Taking Lomotil or opiates for diarrhea; Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); Hematocrit of < 0.47 in men and < 0.42 in women; Percentage deviation from standard weight. The total score ranges from 0 to 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Induction Phase: Change From Baseline in C-Reactive Protein (CRP) Levels at Week 6
Description
C-reactive protein (CRP) is a protein found in the blood, the levels of which rise in response to inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age. Higher levels indicate mild inflammation (10-40 mg/L) and active inflammation (40-200 mg/L).
Time Frame
Baseline and Week 6
Title
Maintenance Phase: Percentage of Participants With Enhanced Clinical Response at Week 52
Description
Enhanced clinical response is defined as a CDAI score at least 100 points lower than the Baseline value. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: Number of liquid or soft stools each day for 7 days; Abdominal pain (graded from 0-3 on severity) each day for 7 days; General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; Presence of complications; Taking Lomotil or opiates for diarrhea; Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); Hematocrit of < 0.47 in men and < 0.42 in women; Percentage deviation from standard weight. The total score ranges from 0 to 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response.
Time Frame
Baseline and Week 52
Title
Maintenance Phase: Percentage of Participants in Corticosteroid-free Clinical Remission at Week 52
Description
Participants using oral corticosteroids at Baseline, who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 52 achieved corticosteroid-free clinical remission. The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free clinical remission.
Time Frame
Week 52
Title
Maintenance Phase: Percentage of Participants With Durable Clinical Remission
Description
Durable clinical remission is defined as CDAI score ≤ 150 points at 80% or more of study visits during the Maintenance Phase, including the Week 52 visit (11 of 13 study visits). The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission
Time Frame
Assessed every 4 weeks from Week 6 to Week 50, and at Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 80 Diagnosis of moderately to severely active Crohn's disease (CD) CD involvement of the ileum and/or colon Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents, within protocol-specified parameters: Immunomodulators Tumor necrosis factor-alpha (TNFα) antagonists Corticosteroids May be receiving a therapeutic dose of conventional therapies for irritable bowel disease (IBD) defined by the protocol Exclusion Criteria Evidence of abdominal abscess at the initial screening visit, other than a minimum of 10 aphthous ulcerations involving a minimum of 10 contiguous cm of intestine Extensive colonic resection, subtotal or total colectomy History of >3 small bowel resections or diagnosis of short bowel syndrome Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine Have received non permitted IBD therapies within either 30 or 60 days, depending on the medication, as stated in the protocol Chronic hepatitis B or C infection Active or latent tuberculosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Millennium Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Apex Clinical Trials
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35234
Country
United States
Facility Name
Gastrointestinal Bioscience
City
Los Angeles
State/Province
California
ZIP/Postal Code
90067
Country
United States
Facility Name
Paramount Medical Specialty
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
Capital Gastroenterology Consultants Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Clinical Applications Laboratories Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Desta Digestive Disease Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Clinical Research, LLC
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Gastroenterology of the Rockies
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Arapahoe Gastroenterology Associates P.C.
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
South Denver Gastroenterology
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Lynn Institute of Pueblo
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81007
Country
United States
Facility Name
Connecticut Gastroenterology Institute
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Gastroenterology Center of Connecticut, P.C.
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
University of Florida, Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
East Coast Institute for Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32223
Country
United States
Facility Name
Borland-Groover Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Center for Advanced Gastroenterology
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Osler Clinical Research
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
United Medical Research Institute
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Compass Research LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Internal Medicine Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
West Wind'r Research & Development, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Shafran Gastroenterology Center
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Southeast Regional Research Group
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Atlanta Center for Gastroenterology, P.C.
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Gastroenterology Associates of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Digestive Research Associates
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
St. Joseph's/Candler Health System
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
DLW Research System
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30039
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Carle Clinic Association P.C.
City
Urbana
State/Province
Illinois
ZIP/Postal Code
58150
Country
United States
Facility Name
Indianapolis Gastroenterology & Hepatology, Inc.- ARC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
Digestive & Liver Consultants
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Iowa Digestive Disease Center
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
University Of Kansas
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Cotton O'Neil Digestive Health Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
University Of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Gastroenterology Associates
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Metropolitan Gastroenterology Group, P.C.
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Shah Associates
City
Prince Frederick
State/Province
Maryland
ZIP/Postal Code
20678
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
The Center for Clinical Studies
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Center for Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Gastroenterology Associates of Western Michigan, P.L.C.
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Minnesota Gastroenterology, P.A.
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55486
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Digestive Health Specialists
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Truman Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Center for Digestive and Liver Diseases, Inc.
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Louis Center for Clinical Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Affiliates in Gastroenterology PA
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersey-NJMS
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
The Gastroenterology Group of South Jersey
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
Facility Name
Hepatobiliary Associates of New York
City
Bayside
State/Province
New York
ZIP/Postal Code
11358
Country
United States
Facility Name
Digestive Health Physician
City
Cheektowaga
State/Province
New York
ZIP/Postal Code
14225
Country
United States
Facility Name
Long Island Clinical Research Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Long Island Gastroenterology Group, P.C.
City
Merrick
State/Province
New York
ZIP/Postal Code
11566
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Present Chapman Marion Steinlauf MD PC
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Kim, Chung MD (Private Practice)
City
Pittsford
State/Province
New York
ZIP/Postal Code
14534
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Long Island Digestive Disease Consultants
City
Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
SUNY Stony Brook University Medical Center
City
Stonybrook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Syracuse Gastroenterological Associates
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Asheville Gastroenterology Associates, P.A.
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Charlotte Gastroentology and Hepatology, P.L.L.C
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Northwest Piedmont Clinical Research, Inc.
City
Elkin
State/Province
North Carolina
ZIP/Postal Code
28621
Country
United States
Facility Name
Burke Research Associates
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Consultants for Clinical Research Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Dayton Science Institute
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Options Health Research
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
The Oregon Clinic-West Hills Gastroenterology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
University of Pittsburgh Medical Center - Cancer Centers
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University Of SC CAR
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Consultants in Gastroenterology
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Gastroenterology Center of the MidSouth, PC
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Austin Gastroenterology, PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Bayou City Research, Ltd.
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Gastroenterology Consultants
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Jacon Medical Research Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Digestive Health Center
City
Pasadena
State/Province
Texas
ZIP/Postal Code
77504
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Gastroenterology Clinic of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Stone Oak Research Foundation
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Digestive Health Specialists of Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Granite Peaks Gastroenterology
City
Sandy
State/Province
Utah
ZIP/Postal Code
84094
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Gastroenterology Associates of Northern Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Digestive and Liver Disease Specialist Ltd.
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Northwest Gastroenterology Associates
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Puget Sound Medical Research
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Facility Name
Pharmaseek, LLC
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States
Facility Name
Wisconsin Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Medical College Of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
GI Research
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H4B9
Country
Canada
Facility Name
Zeidler Ledcor Center-Univerisity of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2X8
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Pharmaseek, LLC
City
Ponce
ZIP/Postal Code
716
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
33200296
Citation
Wyant T, Yang L, Rosario M. Comparison of the ELISA and ECL Assay for Vedolizumab Anti-drug Antibodies: Assessing the Impact on Pharmacokinetics and Safety Outcomes of the Phase 3 GEMINI Trials. AAPS J. 2020 Nov 16;23(1):3. doi: 10.1208/s12248-020-00518-0.
Results Reference
derived
PubMed Identifier
32635680
Citation
Okamoto H, Dirks NL, Rosario M, Hori T, Hibi T. Population pharmacokinetics of vedolizumab in Asian and non-Asian patients with ulcerative colitis and Crohn's disease. Intest Res. 2021 Jan;19(1):95-105. doi: 10.5217/ir.2019.09167. Epub 2020 Jul 10.
Results Reference
derived
PubMed Identifier
30615117
Citation
Sands BE, Van Assche G, Tudor D, Akhundova-Unadkat G, Curtis RI, Tan T. Vedolizumab in Combination With Corticosteroids for Induction Therapy in Crohn's Disease: A Post Hoc Analysis of GEMINI 2 and 3. Inflamm Bowel Dis. 2019 Jul 17;25(8):1375-1382. doi: 10.1093/ibd/izy384.
Results Reference
derived
PubMed Identifier
30203005
Citation
Feagan BG, Sandborn WJ, Colombel JF, Byrne SO, Khalid JM, Kempf C, Geransar P, Bhayat F, Rubin DT. Incidence of Arthritis/Arthralgia in Inflammatory Bowel Disease with Long-term Vedolizumab Treatment: Post Hoc Analyses of the GEMINI Trials. J Crohns Colitis. 2019 Jan 1;13(1):50-57. doi: 10.1093/ecco-jcc/jjy125.
Results Reference
derived
PubMed Identifier
29857145
Citation
Feagan BG, Lasch K, Lissoos T, Cao C, Wojtowicz AM, Khalid JM, Colombel JF. Rapid Response to Vedolizumab Therapy in Biologic-Naive Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2019 Jan;17(1):130-138.e7. doi: 10.1016/j.cgh.2018.05.026. Epub 2018 May 29. Erratum In: Clin Gastroenterol Hepatol. 2020 Mar;18(3):759.
Results Reference
derived
PubMed Identifier
29471381
Citation
Feagan BG, Schwartz D, Danese S, Rubin DT, Lissoos TW, Xu J, Lasch K. Efficacy of Vedolizumab in Fistulising Crohn's Disease: Exploratory Analyses of Data from GEMINI 2. J Crohns Colitis. 2018 Apr 27;12(5):621-626. doi: 10.1093/ecco-jcc/jjy019.
Results Reference
derived
PubMed Identifier
26893500
Citation
Colombel JF, Sands BE, Rutgeerts P, Sandborn W, Danese S, D'Haens G, Panaccione R, Loftus EV Jr, Sankoh S, Fox I, Parikh A, Milch C, Abhyankar B, Feagan BG. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut. 2017 May;66(5):839-851. doi: 10.1136/gutjnl-2015-311079. Epub 2016 Feb 18.
Results Reference
derived
PubMed Identifier
25996351
Citation
Rosario M, Dirks NL, Gastonguay MR, Fasanmade AA, Wyant T, Parikh A, Sandborn WJ, Feagan BG, Reinisch W, Fox I. Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn's disease. Aliment Pharmacol Ther. 2015 Jul;42(2):188-202. doi: 10.1111/apt.13243. Epub 2015 May 20. Erratum In: Aliment Pharmacol Ther. 2015 Nov;42(9):1135.
Results Reference
derived
PubMed Identifier
23964933
Citation
Sandborn WJ, Feagan BG, Rutgeerts P, Hanauer S, Colombel JF, Sands BE, Lukas M, Fedorak RN, Lee S, Bressler B, Fox I, Rosario M, Sankoh S, Xu J, Stephens K, Milch C, Parikh A; GEMINI 2 Study Group. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013 Aug 22;369(8):711-21. doi: 10.1056/NEJMoa1215739.
Results Reference
derived

Learn more about this trial

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

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