Study of Vedolizumab 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:	NCT01224171

Purpose

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.

Condition	Intervention	Phase
Crohn's Disease	Drug: vedolizumab Other: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	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

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 in the tumor necrosis factor alpha antagonist therapy subpopulation [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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)

Estimated Enrollment:	396
Study Start Date:	November 2010
Estimated Study Completion Date:	June 2012
Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vedolizumab	Drug: vedolizumab Vedolizumab will be given as an intravenous (IV) infusion at weeks 0, 2 and 6 Other Name: MLN0002
Placebo Comparator: Placebo	Other: Placebo Placebo will be given as an intravenous (IV) infusion comprised of normal saline at weeks 0, 2 and 6

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224171

Show 41 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:	NCT01224171 History of Changes
Other Study ID Numbers:	C13011
Study First Received:	October 18, 2010
Last Updated:	April 27, 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