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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
History of Changes
  Purpose

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

Condition Intervention Phase
Ulcerative Colitis
 Drug: vedolizumab
Other: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 895
Study Start Date: January 2009
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
  • 1 arm for Induction Phase
  • 2 arms for Maintenance Phase
 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
Placebo Comparator: 2

Placebo add-on Comparator

  • 1 arm for Induction Phase
  • 1 arm for Maintenance Phase
 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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783718

  Show 105 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: NCT00783718     History of Changes
Other Study ID Numbers: C13006
Study First Received: October 31, 2008
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013