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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00783692
First received: October 31, 2008
Last updated: April 8, 2013
Last verified: April 2013

October 31, 2008
April 8, 2013
December 2008
March 2012   (final data collection date for primary outcome measure)
  • Proportion of patients in clinical remission [ Time Frame: Week 6 & 52 ] [ Designated as safety issue: No ]
  • Proportion of patients with enhanced clinical response [ Time Frame: At 6 weeks ] [ Designated as safety issue: No ]
    A greater than or equal to 100-point decrease in Crohn's Disease Activity Index (CDAI) score from baseline (Week 0)
Same as current
Complete list of historical versions of study NCT00783692 on ClinicalTrials.gov Archive Site
Proportion of patients with enhanced clinical response [ Time Frame: Week 6 & 52 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease
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

This multicenter, phase 3, randomized, blinded, placebo-controlled study in patients with moderately to severely active CD 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
Crohn's Disease
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1116
May 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 18 to 80
  2. Diagnosis of moderately to severely active Crohn's disease
  3. CD involvement of the ileum and/or colon
  4. 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
  5. 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. History of >3 small bowel resections or diagnosis of short bowel syndrome
  4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
  5. Have received non permitted IBD therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
  6. Chronic hepatitis B or C infection
  7. 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
 
NCT00783692
C13007
Yes
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
April 2013

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