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Ulcerative ColitisPhase 3GEMINI INCT00783718

Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis

A Phase 3 study testing vedolizumab in people with Ulcerative Colitis, run by Millennium Pharmaceuticals, Inc. at 105 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
vedolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
895 participants
Where
105 sitesin 3 countries
Study dates
Jan 2009to Mar 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Each patient must meet all of the following inclusion criteria to be enrolled in the study:
  • Diagnosis of moderately to severely active ulcerative colitis
  • Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance at least 1 of the following agents:
  • Immunomodulators
  • Tumor necrosis factor-alpha (TNFα) antagonists
  • Corticosteroids
  • May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol

Who cannot join

  • Evidence of abdominal abscess at the initial screening visit
  • Extensive colonic resection, subtotal or total colectomy
  • 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

Trial locations and contacts

105 sites in 3 countries.

105 sites in 3 countries

United States102 sites

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • University of Colorado Health Sciences Center

    Aurora, Colorado, 80045

  • Austin Gastroenterology, PA

    Austin, Texas, 78705

  • University of Maryland Medical Group

    Baltimore, Maryland, 21201

  • Gastroenterology Associates

    Baton Rouge, Louisiana, 70809

  • Hepatobiliary Associates of New York

    Bayside, New York, 11358

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Apex Clinical Trials

    Birmingham, Alabama, 35234

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Medical University Of SC CAR

    Charleston, South Carolina, 29425

  • Charlotte Gastroentology and Hepatology, P.L.L.C

    Charlotte, North Carolina, 28207

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Digestive Health Physician

    Cheektowaga, New York, 14225

  • Metropolitan Gastroenterology Group, P.C.

    Chevy Chase, Maryland, 20815

  • Consultants for Clinical Research Inc.

    Cincinnati, Ohio, 45219

  • Digestive & Liver Consultants

    Clive, Iowa, 50325

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325

  • Southeast Regional Research Group

    Columbus, Georgia, 31904

  • Dayton Science Institute

    Dayton, Ohio, 45415

  • The Center for Clinical Studies

    Dearborn, Michigan, 48124

  • Atlanta Center for Gastroenterology, P.C.

    Decatur, Georgia, 30033

  • Puget Sound Medical Research

    Edmonds, Washington, 98026

  • Northwest Piedmont Clinical Research, Inc.

    Elkin, North Carolina, 28621

  • Gastroenterology Associates of Northern Virginia

    Fairfax, Virginia, 22031

  • University of Florida

    Gainesville, Florida, 32608

  • Gastroenterology Center of the MidSouth, PC

    Germantown, Tennessee, 38138

  • Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • Gastroenterology Center of Connecticut, P.C.

    Hamden, Connecticut, 06518

  • Bayou City Research, Ltd.

    Houston, Texas, 77024

  • Baylor College Of Medicine

    Houston, Texas, 77030

  • Gastroenterology Consultants

    Houston, Texas, 77034

  • Jacon Medical Research Associates

    Houston, Texas, 77090

  • University of Florida, Jacksonville

    Jacksonville, Florida, 32209

  • East Coast Institute for Research

    Jacksonville, Florida, 32223

  • Borland-Groover Clinic

    Jacksonville, Florida, 32256

  • University Of Kansas

    Kansas City, Kansas, 66160

  • Truman Medical Center

    Kansas City, Missouri, 64108

  • Gastroenterology of the Rockies

    Lafayette, Colorado, 80026

  • Rocky Mountain Gastroenterology Associates P.L.L.C.

    Lakewood, Colorado, 80215

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

  • Arapahoe Gastroenterology Associates P.C

    Littleton, Colorado, 80120

  • South Denver Gastroenterology

    Lone Tree, Colorado, 80124

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Gastrointestinal Bioscience

    Los Angeles, California, 90067

  • University Of Louisville

    Louisville, Kentucky, 40202

  • Gastroenterology Associates of Central Georgia

    Macon, Georgia, 31201

  • Pharmaseek, LLC

    Madison, Wisconsin, 53717

  • Osler Clinical Research

    Melbourne, Florida, 32901

  • Long Island Gastroenterology Group, P.C.

    Merrick, New York, 11566

  • Center for Digestive and Liver Diseases, Inc.

    Mexico, Missouri, 65265

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin, 53215

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Paramount Medical Specialty

    Montebello, California, 90640

  • Burke Research Associates

    Morganton, North Carolina, 28655

  • Affiliates in Gastroenterology PA

    Morristown, New Jersey, 07960

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • University of Medicine and Dentistry of New Jersey-NJMS

    New Brunswick, New Jersey, 08903

  • United Medical Research Institute

    New Smyrna Beach, Florida, 32168

  • New York Presbyterian Hospital

    New York, New York, 10021

  • Present Chapman Marion Steinlauf MD PC

    New York, New York, 10028

  • Digestive Research Associates

    Newnan, Georgia, 30263

  • Digestive and Liver Disease Specialist Ltd

    Norfolk, Virginia, 23502

  • Compass Research LLC

    Orlando, Florida, 32806

  • Internal Medicine Specialists

    Orlando, Florida, 32806

  • Digestive Health Center

    Pasadena, Texas, 77504

  • University of Pittsburgh Medical Center - Cancer Centers

    Pittsburgh, Pennsylvania, 15213

  • Kim, Chung MD (Private Practice)

    Pittsford, New York, 14534

  • Minnesota Gastroenterology, P.A.

    Plymouth, Minnesota, 55486

  • The Oregon Clinic-West Hills Gastroenterology

    Portland, Oregon, 97225

  • Shah Associates

    Prince Frederick, Maryland, 20678

  • Lynn Institute of Pueblo

    Pueblo, Colorado, 81007

  • Hunter Holmes McGuire VA Medical Center

    Richmond, Virginia, 23249

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Rochester

    Rochester, New York, 14642

  • Capital Gastroenterology Consultants Medical Group

    Sacramento, California, 95815

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • Gastroenterology Clinic of San Antonio

    San Antonio, Texas, 78229

  • Stone Oak Research Foundation

    San Antonio, Texas, 78258

  • Clinical Applications Laboratories Inc.

    San Diego, California, 92103

  • Desta Digestive Disease Medical Center

    San Diego, California, 92114

  • Granite Peaks Gastroenterology

    Sandy City, Utah, 84094

  • St. Joseph's/Candler Health System

    Savannah, Georgia, 31405

  • Long Island Digestive Disease Consultants

    Setauket, New York, 11733

  • DLW Research System

    Snellville, Georgia, 30039

  • Washington University

    St Louis, Missouri, 63110

  • St. Louis Center for Clinical Research

    St Louis, Missouri, 63128

  • SUNY Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Syracuse Gastroenterological Associates

    Syracuse, New York, 13210

  • University of South Florida

    Tampa, Florida, 33606

  • West Wind'r Research & Development, LLC

    Tampa, Florida, 33607

  • Cotton O'Neil Digestive Health Center

    Topeka, Kansas, 66606

  • Center for Digestive Health

    Troy, Michigan, 48098

  • Options Health Research

    Tulsa, Oklahoma, 74104

  • Digestive Health Specialists of Tyler

    Tyler, Texas, 75701

  • Carle Clinic Association P.C.

    Urbana, Illinois, 61801

  • The Gastroenterology Group of South Jersey

    Vineland, New Jersey, 08360

  • Shafran Gastroenterology Center

    Winter Park, Florida, 32789

  • Gastroenterology Associates of Western Michigan, P.L.C.

    Wyoming, Michigan, 49519

Other trials in United States

Canada2 sites

  • Zeidler Ledcor Center-Univerisity of Alberta

    Edmonton, Alberta, T6G2X8

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

Other trials in Canada

Puerto Rico1 site

  • Pharmaseek, LLC

    Ponce, 716

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis

The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.

Read the detailed description

This multicenter, phase 3, randomized, blinded, placebo-controlled study in patients with moderately to severely active ulcerative colitis comprises two phases:

  • The Induction Phase, designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.
  • The Maintenance Phase, designed to establish the efficacy and safety of vedolizumab for the maintenance of clinical response and 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 meeting protocol-defined criteria were eligible to enroll in Study C13008 (NCT00790933; Long-term Safety) 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 also have been eligible for 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 C13006.

Being tested
vedolizumab, Placebo
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vedolizumabDrug

    Also called Entyvio, MLN0002, MLN02, LDP-02

    Vedolizumab for intravenous infusion

  • PlaceboOther

    Placebo intravenous infusion

Study groups in NCT00783718
Study groupRoleWhat they receive
VedolizumabExperimentalIn 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.
Receives: Drug: vedolizumab
PlaceboPlacebo comparatorIn 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.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Induction Phase: Percentage of Participants With a Clinical Response at Week 6

    Clinical response is defined as a reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point.

    The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).

    All participants who prematurely discontinued for any reason were considered as not achieving clinical response.

    Measured: Baseline and Week 6

  2. Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52

    Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point.

    The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).

    All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.

    Measured: Week 52

Secondary outcomes (6)

  1. Induction Phase: Percentage of Participants in Clinical Remission at Week 6

    Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point.

    The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).

    All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.

    Measured: Week 6

  2. Induction Phase: Percentage of Participants With Mucosal Healing at Week 6

    Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point.

    The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows:

    0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).

    All participants who prematurely discontinued for any reason were considered as not achieving mucosal healing.

    Measured: Week 6

  3. Maintenance Phase: Percentage of Participants With Durable Clinical Response

    Durable clinical response is defined as reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).

    All participants who prematurely discontinued for any reason were considered as not achieving durable clinical response.

    Measured: Baseline, Week 6 and Week 52

  4. Maintenance Phase: Percentage of Participants With Mucosal Healing at Week 52

    Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point.

    The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows:

    0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).

    All participants who prematurely discontinued for any reason were considered as not achieving mucosal healing.

    Measured: Week 52

  5. Maintenance Phase: Percentage of Participants With Durable Clinical Remission

    Durable clinical remission is defined as complete Mayo score of ≤ 2 points and no individual subscore > 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).

    All participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission.

    Measured: Week 6 and Week 52

  6. Maintenance Phase: Percentage of Participants With Corticosteroid-free Remission at Week 52

    Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point. Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission at Week 52.

    The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity).

    All participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free remission.

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2008 (estimated)
  2. Study startJan 2009
  3. Primary completionDec 2011
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
895 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00783718
Sponsor's protocol ID
C13006
Other IDs
U1111-1156-8422, 2008-002782-32, NL25207.096.08, CTRI/2009/091/000128, NMRR-08-1046-2201, C13006CTIL, 09/H1102/66, 2008
Acronym
GEMINI I
Status last verified
Jun 2014
First submitted
31 Oct 2008
Last updated
18 Jul 2014
Data monitoring committee
Yes

Publications

  • Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, Van Assche G, Axler J, Kim HJ, Danese S, Fox I, Milch C, Sankoh S, Wyant T, Xu J, Parikh A; GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013 Aug 22;369(8):699-710. doi: 10.1056/NEJMoa1215734.

    PubMed 23964932

  • Dulai PS, Feagan BG, Sands BE, Chen J, Lasch K, Lirio RA. Prognostic Value of Fecal Calprotectin to Inform Treat-to-Target Monitoring in Ulcerative Colitis. Clin Gastroenterol Hepatol. 2023 Feb;21(2):456-466.e7. doi: 10.1016/j.cgh.2022.07.027. Epub 2022 Aug 4.

    PubMed 35934286

  • 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.

    PubMed 33200296

  • 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.

    PubMed 32635680

  • Loftus EV Jr, Sands BE, Colombel JF, Dotan I, Khalid JM, Tudor D, Geransar P. Sustained Corticosteroid-Free Clinical Remission During Vedolizumab Maintenance Therapy in Patients with Ulcerative Colitis on Stable Concomitant Corticosteroids During Induction Therapy: A Post Hoc Analysis of GEMINI 1. Clin Exp Gastroenterol. 2020 Jun 11;13:211-220. doi: 10.2147/CEG.S248597. eCollection 2020.

    PubMed 32606883

  • Dulai PS, Singh S, Vande Casteele N, Meserve J, Winters A, Chablaney S, Aniwan S, Shashi P, Kochhar G, Weiss A, Koliani-Pace JL, Gao Y, Boland BS, Chang JT, Faleck D, Hirten R, Ungaro R, Lukin D, Sultan K, Hudesman D, Chang S, Bohm M, Varma S, Fischer M, Shmidt E, Swaminath A, Gupta N, Rosario M, Jairath V, Guizzetti L, Feagan BG, Siegel CA, Shen B, Kane S, Loftus EV Jr, Sandborn WJ, Sands BE, Colombel JF, Lasch K, Cao C. Development and Validation of Clinical Scoring Tool to Predict Outcomes of Treatment With Vedolizumab in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Dec;18(13):2952-2961.e8. doi: 10.1016/j.cgh.2020.02.010. Epub 2020 Feb 13.

    PubMed 32062041

  • Feagan BG, Schreiber S, Wolf DC, Axler JL, Kaviya A, James A, Curtis RI, Geransar P, Stallmach A, Ehehalt R, Bokemeyer B, Khalid JM, O'Byrne S. Sustained Clinical Remission With Vedolizumab in Patients With Moderate-to-Severe Ulcerative Colitis. Inflamm Bowel Dis. 2019 May 4;25(6):1028-1035. doi: 10.1093/ibd/izy323.

    PubMed 30365009

  • Sandborn WJ, Colombel JF, Panaccione R, Dulai PS, Rosario M, Cao C, Barocas M, Lasch K. Deep Remission With Vedolizumab in Patients With Moderately to Severely Active Ulcerative Colitis: A GEMINI 1 post hoc Analysis. J Crohns Colitis. 2019 Feb 1;13(2):172-181. doi: 10.1093/ecco-jcc/jjy149.

    PubMed 30285104

  • 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.

    PubMed 30203005

  • 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.

    PubMed 29857145

  • Arijs I, De Hertogh G, Lemmens B, Van Lommel L, de Bruyn M, Vanhove W, Cleynen I, Machiels K, Ferrante M, Schuit F, Van Assche G, Rutgeerts P, Vermeire S. Effect of vedolizumab (anti-alpha4beta7-integrin) therapy on histological healing and mucosal gene expression in patients with UC. Gut. 2018 Jan;67(1):43-52. doi: 10.1136/gutjnl-2016-312293. Epub 2016 Oct 7.

    PubMed 27802155

  • Feagan BG, Rubin DT, Danese S, Vermeire S, Abhyankar B, Sankoh S, James A, Smyth M. Efficacy of Vedolizumab Induction and Maintenance Therapy in Patients With Ulcerative Colitis, Regardless of Prior Exposure to Tumor Necrosis Factor Antagonists. Clin Gastroenterol Hepatol. 2017 Feb;15(2):229-239.e5. doi: 10.1016/j.cgh.2016.08.044. Epub 2016 Sep 14.

    PubMed 27639327

  • 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.

    PubMed 26893500

  • 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.

    PubMed 25996351

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing vedolizumab in people with Ulcerative Colitis, run by Millennium Pharmaceuticals, Inc. at 105 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 105 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Induction Phase: Percentage of Participants With a Clinical Response at Week 6 (time frame: Baseline and Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00783718, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2014.

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