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

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn's Disease
• Intervention / Treatment: Other: Placebo; Drug: vedolizumab

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.

• Study Type: Interventional
• Enrollment (Actual): 1116
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G2X8
      • Zeidler Ledcor Center-Univerisity of Alberta
    • Edmonton, Alberta, Canada, T5H4B9
      • GI Research
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital
• Puerto Rico
  • Ponce, Puerto Rico, 716
    • Pharmaseek, LLC
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
    • Birmingham, Alabama, United States, 35234
      • Apex Clinical Trials
  • California
    • Los Angeles, California, United States, 90067
      • Gastrointestinal Bioscience
    • Montebello, California, United States, 90640
      • Paramount Medical Specialty
    • Sacramento, California, United States, 95815
      • Capital Gastroenterology Consultants Medical Group
    • San Diego, California, United States, 92114
      • Desta Digestive Disease Medical Center
    • San Diego, California, United States, 92103
      • Clinical Applications Laboratories Inc.
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Health Sciences Center
    • Golden, Colorado, United States, 80401
      • Rocky Mountain Clinical Research, LLC
    • Lafayette, Colorado, United States, 80026
      • Gastroenterology of the Rockies
    • Littleton, Colorado, United States, 80120
      • Arapahoe Gastroenterology Associates P.C.
    • Lone Tree, Colorado, United States, 80124
      • South Denver Gastroenterology
    • Pueblo, Colorado, United States, 81007
      • Lynn Institute of Pueblo
  • Connecticut
    • Bristol, Connecticut, United States, 06010
      • Connecticut Gastroenterology Institute
    • Hamden, Connecticut, United States, 06518
      • Gastroenterology Center of Connecticut, P.C.
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida
    • Jacksonville, Florida, United States, 32256
      • Borland-Groover Clinic
    • Jacksonville, Florida, United States, 32209
      • University of Florida, Jacksonville
    • Jacksonville, Florida, United States, 32223
      • East Coast Institute for Research
    • Maitland, Florida, United States, 32751
      • Center for Advanced Gastroenterology
    • Melbourne, Florida, United States, 32901
      • Osler Clinical Research
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine
    • New Smyrna Beach, Florida, United States, 32168
      • United Medical Research Institute
    • Orlando, Florida, United States, 32806
      • Compass Research LLC
    • Orlando, Florida, United States, 32806
      • Internal Medicine Specialists
    • Tampa, Florida, United States, 33606
      • University of South Florida
    • Tampa, Florida, United States, 33607
      • West Wind'r Research & Development, LLC
    • Winter Park, Florida, United States, 32789
      • Shafran Gastroenterology Center
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Gastroenterology Associates
    • Columbus, Georgia, United States, 31904
      • Southeast Regional Research Group
    • Decatur, Georgia, United States, 30033
      • Atlanta Center for Gastroenterology, P.C.
    • Macon, Georgia, United States, 31201
      • Gastroenterology Associates of Central Georgia
    • Newnan, Georgia, United States, 30263
      • Digestive Research Associates
    • Savannah, Georgia, United States, 31405
      • St. Joseph's/Candler Health System
    • Snellville, Georgia, United States, 30039
      • DLW Research System
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Urbana, Illinois, United States, 58150
      • Carle Clinic Association P.C.
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • Indianapolis Gastroenterology & Hepatology, Inc.- ARC
  • Iowa
    • Clive, Iowa, United States, 50325
      • Iowa Digestive Disease Center
    • Clive, Iowa, United States, 50325
      • Digestive & Liver Consultants
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas
    • Topeka, Kansas, United States, 66606
      • Cotton O'Neil Digestive Health Center
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Medical Center
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Gastroenterology Associates
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Metropolitan Gastroenterology Group, P.C.
    • Prince Frederick, Maryland, United States, 20678
      • Shah Associates
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
  • Michigan
    • Dearborn, Michigan, United States, 48124
      • The Center for Clinical Studies
    • Troy, Michigan, United States, 48098
      • Center for Digestive Health
    • Wyoming, Michigan, United States, 49519
      • Gastroenterology Associates of Western Michigan, P.L.C.
  • Minnesota
    • Plymouth, Minnesota, United States, 55486
      • Minnesota Gastroenterology, P.A.
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Digestive Health Specialists
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Truman Medical Center
    • Mexico, Missouri, United States, 65265
      • Center for Digestive and Liver Diseases, Inc.
    • St. Louis, Missouri, United States, 63110
      • Washington University
    • St. Louis, Missouri, United States, 63128
      • St. Louis Center for Clinical Research
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Affiliates in Gastroenterology PA
    • New Brunswick, New Jersey, United States, 08903
      • University of Medicine and Dentistry of New Jersey-NJMS
    • Vineland, New Jersey, United States, 08360
      • The Gastroenterology Group of South Jersey
  • New York
    • Bayside, New York, United States, 11358
      • Hepatobiliary Associates of New York
    • Cheektowaga, New York, United States, 14225
      • Digestive Health Physician
    • Great Neck, New York, United States, 11021
      • Long Island Clinical Research Associates
    • Merrick, New York, United States, 11566
      • Long Island Gastroenterology Group, P.C.
    • New York, New York, United States, 10021
      • New York Presbyterian Hospital
    • New York, New York, United States, 10028
      • Present Chapman Marion Steinlauf MD PC
    • Pittsford, New York, United States, 14534
      • Kim, Chung MD (Private Practice)
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Setauket, New York, United States, 11733
      • Long Island Digestive Disease Consultants
    • Stonybrook, New York, United States, 11794
      • SUNY Stony Brook University Medical Center
    • Syracuse, New York, United States, 13210
      • Syracuse Gastroenterological Associates
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Asheville Gastroenterology Associates, P.A.
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Charlotte, North Carolina, United States, 28207
      • Charlotte Gastroentology and Hepatology, P.L.L.C
    • Elkin, North Carolina, United States, 28621
      • Northwest Piedmont Clinical Research, Inc.
    • Morganton, North Carolina, United States, 28655
      • Burke Research Associates
    • Winston Salem, North Carolina, United States, 27157
      • Wake Forest University Baptist Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Consultants for Clinical Research Inc.
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Dayton, Ohio, United States, 45415
      • Dayton Science Institute
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Options Health Research
  • Oregon
    • Portland, Oregon, United States, 97225
      • The Oregon Clinic-West Hills Gastroenterology
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center - Cancer Centers
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University Of SC CAR
    • Columbia, South Carolina, United States, 29203
      • Consultants in Gastroenterology
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Gastroenterology Center of the MidSouth, PC
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Gastroenterology, PA
    • Houston, Texas, United States, 77034
      • Gastroenterology Consultants
    • Houston, Texas, United States, 77024
      • Bayou City Research, Ltd.
    • Houston, Texas, United States, 77090
      • Jacon Medical Research Associates
    • Pasadena, Texas, United States, 77504
      • Digestive Health Center
    • San Antonio, Texas, United States, 78229
      • Gastroenterology Clinic of San Antonio
    • San Antonio, Texas, United States, 78215
      • Alamo Medical Research
    • San Antonio, Texas, United States, 78258
      • Stone Oak Research Foundation
    • Tyler, Texas, United States, 75701
      • Digestive Health Specialists of Tyler
  • Utah
    • Sandy, Utah, United States, 84094
      • Granite Peaks Gastroenterology
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
    • Fairfax, Virginia, United States, 22031
      • Gastroenterology Associates of Northern Virginia
    • Norfolk, Virginia, United States, 23502
      • Digestive and Liver Disease Specialist Ltd.
    • Richmond, Virginia, United States, 23249
      • Hunter Holmes McGuire VA Medical Center
  • Washington
    • Bellevue, Washington, United States, 98004
      • Northwest Gastroenterology Associates
    • Edmonds, Washington, United States, 98026
      • Puget Sound Medical Research
  • Wisconsin
    • Madison, Wisconsin, United States, 53717
      • Pharmaseek, LLC
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Wisconsin Center for Advanced Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vedolizumab; 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.	Drug: vedolizumab; Vedolizumab for intravenous infusion; Other Names: Entyvio; MLN0002; MLN02; LDP-02
Placebo Comparator: Placebo; 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.	Other: Placebo; Placebo intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 6
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.	Baseline and Week 6
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.	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline and Week 6
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.	Baseline and Week 52
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.	Week 52
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	Assessed every 4 weeks from Week 6 to Week 50, and at Week 52

Collaborators and Investigators

• Sponsor: Millennium Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: October 31, 2008
• First Submitted That Met QC Criteria: October 31, 2008
• First Posted (Estimate): November 2, 2008

Study Record Updates

• Last Update Posted (Estimate): July 21, 2014
• Last Update Submitted That Met QC Criteria: June 19, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Gastrointestinal Agents; Vedolizumab
• Other Study ID Numbers: C13007; 2008-002783-33 (EudraCT Number); U1111-1157-7675 (Registry Identifier: WHO); CTRI/2009/091/000135 (Registry Identifier: CTRI); NMRR-08-1047-2202 (Registry Identifier: NMRR); 09/H1102/65 (Registry Identifier: NRES); NL25208.096.08 (Registry Identifier: CCMO); C13007CTIL (Other Identifier: Israel MoH)