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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01224171
First received: October 18, 2010
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

This phase 3, randomized, blinded, placebo-controlled 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.

After completing the study, patients may be eligible to enroll in a long term safety study with continued access to vedolizumab.


Condition Intervention Phase
Crohn's Disease
Drug: vedolizumab
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Proportion of patients in clinical remission in the tumor necrosis factor alpha antagonist therapy subpopulation [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients in clinical remission [ Time Frame: Week 6 and Week 10 ] [ Designated as safety issue: No ]
  • Proportion of patients with sustained clinical remission [ Time Frame: Week 6 and Week 10 ] [ Designated as safety issue: No ]
  • Proportion of patients with enhanced clinical response [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Safety profile [ Time Frame: Through Week 22 ] [ Designated as safety issue: Yes ]
    Adverse events, serious adverse events, results of standard laboratory tests and results of 12-lead electrocardiograms (ECGs)


Enrollment: 416
Study Start Date: November 2010
Study Completion Date: April 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vedolizumab Drug: vedolizumab
Vedolizumab will be given as an intravenous (IV) infusion at weeks 0, 2 and 6
Other Name: MLN0002
Placebo Comparator: Placebo Other: Placebo
Placebo will be given as an intravenous (IV) infusion comprised of normal saline at weeks 0, 2 and 6

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 80
  • Diagnosis of moderately to severely active Crohn's disease
  • Crohn's Disease involvement of the ileum and/or colon
  • Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol
  • May be receiving a therapeutic dose of conventional therapies for 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; HIV infection
  • Active or latent tuberculosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224171

  Show 41 Study Locations
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01224171     History of Changes
Other Study ID Numbers: C13011
Study First Received: October 18, 2010
Last Updated: March 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 17, 2014