Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease - Full Text View

Sponsor:	Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):	Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00783692

Purpose

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.

Condition	Intervention	Phase
Crohn's Disease	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 Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

U.S. FDA Resources

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

Primary Outcome Measures:

Proportion of patients in clinical remission [ Time Frame: Week 6 & 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients with enhanced clinical response [ Time Frame: Week 6 & 52 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1059
Study Start Date:	December 2008
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	July 2012 (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

Criteria

Inclusion Criteria:

Age 18 to 80
Diagnosis of moderately to severely active Crohn's disease
CD 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 IBD therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
Chronic hepatitis B or C infection
Active or latent tuberculosis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783692

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:	NCT00783692 History of Changes
Other Study ID Numbers:	C13007
Study First Received:	October 31, 2008
Last Updated:	March 1, 2012
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 May 23, 2012