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Completed

NCT Number: NCT01224171

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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zeidler Ledcor Center-Univerisity of Alberta, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vedolizumab

Drug

Vedolizumab for intravenous infusion

Other names: Entyvio, MLN0002, MLN02, LDP-02

Placebo

Other

Placebo intravenous infusion

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Percentage of Participants in Clinical Remission at Week 6 in the Overall Population

    Time frame: 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.

  2. Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation

    Time frame: Week 10

    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.

  3. Percentage of Participants in Clinical Remission at Week 10 in the Overall Population

    Time frame: Week 10

    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.

  4. Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population

    Time frame: Week 6 and Week 10

    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.

  5. Percentage of Participants With Sustained Clinical Remission in the Overall Population

    Time frame: Week 6 and Week 10

    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.

  6. Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation

    Time frame: Baseline and Week 6

    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.

  7. Number of Participants With Adverse Events (AEs)

    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.

    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?

Sponsors and collaborators

Lead sponsor

Millennium Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Acronym: GEMINI III

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 19, 2010
Registry last updated
Jul 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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