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

October 18, 2010
March 7, 2013
November 2010
February 2012   (final data collection date for primary outcome measure)
Proportion of patients in clinical remission in the tumor necrosis factor alpha antagonist therapy subpopulation [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01224171 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Crohn's Disease
  • Drug: vedolizumab
    Vedolizumab will be given as an intravenous (IV) infusion at weeks 0, 2 and 6
    Other Name: MLN0002
  • Other: Placebo
    Placebo will be given as an intravenous (IV) infusion comprised of normal saline at weeks 0, 2 and 6
  • Experimental: Vedolizumab
    Intervention: Drug: vedolizumab
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
416
April 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01224171
C13011
Yes
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP