Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease

Crohn's Disease Clinical Trial

— GEMINI III  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224171
• Other study ID #: C13011
• Secondary ID: U1111-1158-25812
• Status: Completed
• Phase: Phase 3
• First received: October 18, 2010
• Last updated: June 19, 2014
• Start date: November 2010
• Est. completion date: April 2012

Study information

• Verified date: June 2014
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This 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.

Description:

After completing the study, patients were eligible to enroll in a long term safety study with continued access to vedolizumab (study C13008; NCT00790933) if study drug was well tolerated, and no major surgical intervention for Crohn's disease occurred or was required.

Participants who did not enroll in Study C13008 were to complete the Final Safety visit (16 weeks after the last dose of study drug) for a maximum time on study of 22 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 416
• Est. completion date: April 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 inflammatory bowel disease (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; human immunodeficiency virus (HIV) infection

• Active or latent tuberculosis

Study Design

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• vedolizumab
Vedolizumab for intravenous infusion

Other:
• Placebo
Placebo intravenous infusion

Locations

Country	Name	City	State
Canada	Zeidler Ledcor Center-Univerisity of Alberta	Edmonton	Alberta
United States	University of Michigan	Ann Arbor	Michigan
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Gastroenterology Associates	Baton Rouge	Louisiana
United States	Massachusetts General Hospital Crohn's and Colitis Center	Boston	Massachusetts
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Charlotte Gastroenterology and Hepatology P.L.L.C	Charlotte	North Carolina
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Metropolitan Gastroenterology Group P.C.	Chevy Chase	Maryland
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Consultants for Clinical Research Inc.	Cincinnati	Ohio
United States	Consultants in Gastroenterology	Columbia	South Carolina
United States	University of Florida	Gainesville	Florida
United States	Gastroenterology Center of the MidSouth PC	Germantown	Tennessee
United States	Long Island Clinical Research Associates	Great Neck	New York
United States	Gastroenterology Center of Connecticut P.C.	Hamden	Connecticut
United States	Gastroenterology Research of New Orleans	Hammond	Louisiana
United States	Mid-Atlantic Medical Research Center	Hollywood	Maryland
United States	Gastroenterology of the Rockies	Lafayette	Colorado
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	University Of Louisville	Louisville	Kentucky
United States	Gastroenterology Associates of Central Georgia	Macon	Georgia
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Medical College Of Wisconsin	Milwaukee	Wisconsin
United States	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin
United States	New York Presbyterian Hospital	New York	New York
United States	Minnesota Gastroenterology P.A.	Plymouth	Minnesota
United States	The Oregon Clinic-West Hills Gastroenterology	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester	Rochester	New York
United States	Gastroenterology Clinic of San Antonio	San Antonio	Texas
United States	University of Washington School of Medicine	Seattle	Washington
United States	Washington University	St. Louis	Missouri
United States	Atlanta Gastroenterology Specialist PC	Suwanee	Georgia
United States	Cotton O'Neil Digestive Health Center	Topeka	Kansas
United States	Center for Digestive Health	Troy	Michigan
United States	Options Health Research	Tulsa	Oklahoma
United States	Digestive Health Specialists of Tyler	Tyler	Texas
United States	Shafran Gastroenterology Center	Winter Park	Florida
United States	Huron Gastroenterology Associates	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFa) Antagonist Failure Subpopulation	Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score = 150 points.; The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: Number of liquid or soft stools each day for 7 days; Abdominal pain (graded from 0-3 on severity) each day for 7 days; General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; Presence of complications; Taking Lomotil or opiates for diarrhea; Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); Hematocrit of < 0.47 in men and < 0.42 in women; Percentage deviation from standard weight.; The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.; All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.	Week 6	No
Secondary	Percentage of Participants in Clinical Remission at Week 6 in the Overall Population	Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score = 150 points.; The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: Number of liquid or soft stools each day for 7 days; Abdominal pain (graded from 0-3 on severity) each day for 7 days; General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; Presence of complications; Taking Lomotil or opiates for diarrhea; Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); Hematocrit of < 0.47 in men and < 0.42 in women; Percentage deviation from standard weight.; The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.; All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.	Week 6	No
Secondary	Percentage of Participants in Clinical Remission at Week 10 in the TNFa Antagonist Failure Subpopulation	Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score = 150 points.; The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: Number of liquid or soft stools each day for 7 days; Abdominal pain (graded from 0-3 on severity) each day for 7 days; General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; Presence of complications; Taking Lomotil or opiates for diarrhea; Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); Hematocrit of < 0.47 in men and < 0.42 in women; Percentage deviation from standard weight.; The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.; All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.	Week 10	No
Secondary	Percentage of Participants in Clinical Remission at Week 10 in the Overall Population	Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score = 150 points.; The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: Number of liquid or soft stools each day for 7 days; Abdominal pain (graded from 0-3 on severity) each day for 7 days; General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; Presence of complications; Taking Lomotil or opiates for diarrhea; Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); Hematocrit of < 0.47 in men and < 0.42 in women; Percentage deviation from standard weight.; The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.; All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.	Week 10	No
Secondary	Percentage of Participants With Sustained Clinical Remission in the TNFa Antagonist Failure Population	Sustained clinical remission is defined as a CDAI score = 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: Number of liquid or soft stools each day for 7 days; Abdominal pain (graded from 0-3 on severity) each day for 7 days; General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; Presence of complications; Taking Lomotil or opiates for diarrhea; Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); Hematocrit of < 0.47 in men and < 0.42 in women; Percentage deviation from standard weight.; The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.; All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission.	Week 6 and Week 10	No
Secondary	Percentage of Participants With Sustained Clinical Remission in the Overall Population	Sustained clinical remission is defined as a CDAI score = 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: Number of liquid or soft stools each day for 7 days; Abdominal pain (graded from 0-3 on severity) each day for 7 days; General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; Presence of complications; Taking Lomotil or opiates for diarrhea; Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); Hematocrit of < 0.47 in men and < 0.42 in women; Percentage deviation from standard weight.; The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.; All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission.	Week 6 and Week 10	No
Secondary	Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFa Antagonist Failure Subpopulation	Enhanced clinical response is defined as a = 100-point decrease in CDAI score from Baseline.; The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: Number of liquid or soft stools each day for 7 days; Abdominal pain (graded from 0-3 on severity) each day for 7 days; General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; Presence of complications; Taking Lomotil or opiates for diarrhea; Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); Hematocrit of < 0.47 in men and < 0.42 in women; Percent deviation from standard weight.; The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.; All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response.	Baseline and Week 6	No
Secondary	Number of Participants With Adverse Events (AEs)	An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was any AE, occurring at any dose and regardless of causality that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event based upon appropriate medical judgment that may have jeopardized the patient and may have required medical or surgical intervention to prevent 1 of the outcomes listed above, or any diagnosis of progressive multifocal leukoencephalopathy (PML).; Relationship to study drug administration was determined by the investigator responding yes or no to the question: Is there a reasonable possibility that the AE is associated with the study drug?	From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments.	Yes