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

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:

  • Age 18 to 80
  • Diagnosis of moderately to severely active Crohn's disease
  • Crohn's Disease 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 one conventional therapy as defined by the protocol
  • May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol

Exclusion Criteria

  • Evidence of abdominal abscess at the initial screening visit
  • 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 therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
  • Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) infection
  • Active or latent tuberculosis

Sites / Locations

  • Gastroenterology of the Rockies
  • Gastroenterology Center of Connecticut P.C.
  • University of Florida
  • University of Miami Miller School of Medicine
  • Shafran Gastroenterology Center
  • Atlanta Gastroenterology Associates
  • Gastroenterology Associates of Central Georgia
  • Atlanta Gastroenterology Specialist PC
  • University of Chicago Medical Center
  • Cotton O'Neil Digestive Health Center
  • University of Kentucky Medical Center
  • University Of Louisville
  • Gastroenterology Associates
  • Gastroenterology Research of New Orleans
  • Metropolitan Gastroenterology Group P.C.
  • Mid-Atlantic Medical Research Center
  • Massachusetts General Hospital Crohn's and Colitis Center
  • University of Michigan
  • Center for Digestive Health
  • Huron Gastroenterology Associates
  • Minnesota Gastroenterology P.A.
  • Mayo Clinic
  • Washington University
  • Dartmouth-Hitchcock Medical Center
  • Long Island Clinical Research Associates
  • New York Presbyterian Hospital
  • University of Rochester
  • University of North Carolina at Chapel Hill
  • Charlotte Gastroenterology and Hepatology P.L.L.C
  • Consultants for Clinical Research Inc.
  • Options Health Research
  • The Oregon Clinic-West Hills Gastroenterology
  • Consultants in Gastroenterology
  • Gastroenterology Center of the MidSouth PC
  • Gastroenterology Clinic of San Antonio
  • Digestive Health Specialists of Tyler
  • University of Virginia Health System
  • University of Washington School of Medicine
  • Wisconsin Center for Advanced Research
  • Medical College Of Wisconsin
  • Zeidler Ledcor Center-Univerisity of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Vedolizumab

Arm Description

Participants received placebo intravenous infusion at Weeks 0, 2 and 6.

Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.

Outcomes

Primary Outcome Measures

Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation
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.

Secondary Outcome Measures

Percentage of Participants in Clinical Remission at Week 6 in the Overall Population
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.
Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation
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.
Percentage of Participants in Clinical Remission at Week 10 in the Overall Population
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.
Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population
Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. 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 sustained clinical remission.
Percentage of Participants With Sustained Clinical Remission in the Overall Population
Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. 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 sustained clinical remission.
Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation
Enhanced clinical response is defined as a ≥ 100-point decrease in CDAI score from 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; Percent 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 enhanced clinical response.
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was any AE, occurring at any dose and regardless of causality that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event based upon appropriate medical judgment that may have jeopardized the patient and may have required medical or surgical intervention to prevent 1 of the outcomes listed above, or any diagnosis of progressive multifocal leukoencephalopathy (PML). Relationship to study drug administration was determined by the investigator responding yes or no to the question: Is there a reasonable possibility that the AE is associated with the study drug?

Full Information

First Posted
October 18, 2010
Last Updated
June 19, 2014
Sponsor
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01224171
Brief Title
Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease
Acronym
GEMINI III
Official Title
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab 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
November 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
April 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
This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.
Detailed Description
After completing the study, patients were eligible to enroll in a long term safety study with continued access to vedolizumab (study C13008; NCT00790933) if study drug was well tolerated, and no major surgical intervention for Crohn's disease occurred or was required. Participants who did not enroll in Study C13008 were to complete the Final Safety visit (16 weeks after the last dose of study drug) for a maximum time on study of 22 weeks.

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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
416 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
Arm Title
Vedolizumab
Arm Type
Experimental
Arm Description
Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
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
Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation
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
Secondary Outcome Measure Information:
Title
Percentage of Participants in Clinical Remission at Week 6 in the Overall Population
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
Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation
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 10
Title
Percentage of Participants in Clinical Remission at Week 10 in the Overall Population
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 10
Title
Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population
Description
Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. 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 sustained clinical remission.
Time Frame
Week 6 and Week 10
Title
Percentage of Participants With Sustained Clinical Remission in the Overall Population
Description
Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. 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 sustained clinical remission.
Time Frame
Week 6 and Week 10
Title
Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation
Description
Enhanced clinical response is defined as a ≥ 100-point decrease in CDAI score from 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; Percent 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 enhanced clinical response.
Time Frame
Baseline and Week 6
Title
Number of Participants With Adverse Events (AEs)
Description
An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was any AE, occurring at any dose and regardless of causality that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event based upon appropriate medical judgment that may have jeopardized the patient and may have required medical or surgical intervention to prevent 1 of the outcomes listed above, or any diagnosis of progressive multifocal leukoencephalopathy (PML). Relationship to study drug administration was determined by the investigator responding yes or no to the question: Is there a reasonable possibility that the AE is associated with the study drug?
Time Frame
From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments.

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 Crohn's Disease 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 one conventional therapy as defined by the protocol May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol Exclusion Criteria Evidence of abdominal abscess at the initial screening visit 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 therapies within either 30 or 60 days, depending on the medication, as stated in the protocol Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) 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
Gastroenterology of the Rockies
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Gastroenterology Center of Connecticut P.C.
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
65180
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
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
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
Gastroenterology Associates of Central Georgia
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Atlanta Gastroenterology Specialist PC
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
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
40402
Country
United States
Facility Name
Gastroenterology Associates
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Gastroenterology Research of New Orleans
City
Hammond
State/Province
Louisiana
ZIP/Postal Code
70403
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
Mid-Atlantic Medical Research Center
City
Hollywood
State/Province
Maryland
ZIP/Postal Code
20636
Country
United States
Facility Name
Massachusetts General Hospital Crohn's and Colitis Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Center for Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Huron Gastroenterology Associates
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Minnesota Gastroenterology P.A.
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
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
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
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 Gastroenterology and Hepatology P.L.L.C
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Consultants for Clinical Research Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
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
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
Gastroenterology Clinic of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Digestive Health Specialists of Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Washington School of Medicine
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
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
Zeidler Ledcor Center-Univerisity of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2X8
Country
Canada

12. IPD Sharing Statement

Citations:
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
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Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease

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