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Crohn's DiseasePhase 3GEMINI IINCT00783692

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

A Phase 3 study testing vedolizumab in people with Crohn's Disease, run by Millennium Pharmaceuticals, Inc. at 114 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 and remission 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
Crohn's Disease
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
1,116 participants
Where
114 sitesin 3 countries
Study dates
Dec 2008to May 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

  • 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

Who cannot join

  • 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

Trial locations and contacts

114 sites in 3 countries.

114 sites in 3 countries

United States110 sites

  • Asheville Gastroenterology Associates, P.A.

    Asheville, North Carolina, 28801

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342

  • University of Colorado Health Sciences Center

    Aurora, Colorado, 80045

  • Austin Gastroenterology, PA

    Austin, Texas, 78705

  • Gastroenterology Associates

    Baton Rouge, Louisiana, 70809

  • Hepatobiliary Associates of New York

    Bayside, New York, 11358

  • Northwest Gastroenterology Associates

    Bellevue, Washington, 98004

  • 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

  • Connecticut Gastroenterology Institute

    Bristol, Connecticut, 06010

  • 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

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Consultants for Clinical Research Inc.

    Cincinnati, Ohio, 45219

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Digestive & Liver Consultants

    Clive, Iowa, 50325

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325

  • Consultants in Gastroenterology

    Columbia, South Carolina, 29203

  • 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

  • Rocky Mountain Clinical Research, LLC

    Golden, Colorado, 80401

  • 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

  • Gastroenterology Consultants

    Houston, Texas, 77034

  • Jacon Medical Research Associates

    Houston, Texas, 77090

  • Indianapolis Gastroenterology & Hepatology, Inc.- ARC

    Indianapolis, Indiana, 46237

  • 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

  • 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

  • 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

  • Center for Advanced Gastroenterology

    Maitland, Florida, 32751

  • 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

    Tupelo, Mississippi, 38801

  • Digestive Health Specialists of Tyler

    Tyler, Texas, 75701

  • Carle Clinic Association P.C.

    Urbana, Illinois, 58150

  • The Gastroenterology Group of South Jersey

    Vineland, New Jersey, 08360

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

  • Shafran Gastroenterology Center

    Winter Park, Florida, 32789

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

    Wyoming, Michigan, 49519

Other trials in United States

Canada3 sites

  • GI Research

    Edmonton, Alberta, T5H4B9

  • 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 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.

Read the 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.

Conditions
Crohn's Disease
Being tested
vedolizumab, Placebo
Medical subject headings
Crohn Disease

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 NCT00783692
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 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.

    Measured: Week 6

  2. 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.

    Measured: Baseline and Week 6

  3. 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.

    Measured: Week 52

Secondary outcomes (4)

  1. 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).

    Measured: Baseline and Week 6

  2. 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.

    Measured: Baseline and Week 52

  3. 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.

    Measured: Week 52

  4. 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

    Measured: Assessed every 4 weeks from Week 6 to Week 50, and at 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 startDec 2008
  3. Primary completionMar 2012
  4. Study completionMay 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
Factorial
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00783692
Sponsor's protocol ID
C13007
Other IDs
2008-002783-33, U1111-1157-7675, CTRI/2009/091/000135, NMRR-08-1047-2202, 09/H1102/65, NL25208.096.08, C13007CTIL, 2008
Acronym
GEMINI II
Status last verified
Jun 2014
First submitted
31 Oct 2008
Last updated
21 Jul 2014
Data monitoring committee
Yes

Publications

  • 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

  • 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.

    PubMed 30615117

  • 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

  • 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.

    PubMed 29471381

  • 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

  • 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.

    PubMed 23964933

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing vedolizumab in people with Crohn's Disease, run by Millennium Pharmaceuticals, Inc. at 114 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 8 inclusion and 7 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 21 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 114 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 21 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 Achieving Clinical Remission at Week 6 (time frame: Week 6). The study lists 3 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 NCT00783692, which also lists 9 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 21 Jul 2014.

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