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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00783718
First received: October 31, 2008
Last updated: March 18, 2013
Last verified: March 2013

October 31, 2008
March 18, 2013
January 2009
December 2011   (final data collection date for primary outcome measure)
  • Proportion of patients with clinical response [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Proportion of patients in clinical remission [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00783718 on ClinicalTrials.gov Archive Site
  • Proportion of patients in clinical remission [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • Proportion of patients in clinical response [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis
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

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 (MLN0002) for the induction of clinical response and remission
  • The Maintenance Phase, designed to establish the efficacy and safety of vedolizumab (MLN0002) for the maintenance of clinical response and remission
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Ulcerative Colitis
  • Drug: vedolizumab
    Vedolizumab (MLN0002) is given at weeks 0, 2, 6 and then at 4-week intervals, or 8-week intervals for up to one year.
    Other Name: MLN0002
  • Other: Placebo
    The placebo infusion (IV) will be composed of normal saline. This is given at weeks 0, 2, 6 and then at 4-weekly intervals for up to one year.
  • Experimental: 1
    • 1 arm for Induction Phase
    • 2 arms for Maintenance Phase
    Intervention: Drug: vedolizumab
  • Placebo Comparator: 2

    Placebo add-on Comparator

    • 1 arm for Induction Phase
    • 1 arm for Maintenance Phase
    Intervention: Other: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
895
April 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

1. Age 18 to 80

2 Diagnosis of moderately to severely active ulcerative colitis

3. 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

4. May be receiving a therapeutic dose of conventional therapies for IBD as defined by the protocol

Exclusion Criteria:

  1. Evidence of abdominal abscess at the initial screening visit
  2. Extensive colonic resection, subtotal or total colectomy
  3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
  4. Have received non permitted IBD therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
  5. Chronic hepatitis B or C infection
  6. 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,   Puerto Rico
 
NCT00783718
C13006
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