Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease
- Registration Number
- NCT01224171
- Lead Sponsor
- Millennium Pharmaceuticals, Inc.
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 416
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received placebo intravenous infusion at Weeks 0, 2 and 6. Vedolizumab vedolizumab Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
- Primary Outcome Measures
Name Time Method Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation Week 6 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Sustained Clinical Remission in the Overall Population Week 6 and Week 10 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.Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation Baseline and Week 6 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.Percentage of Participants in Clinical Remission at Week 6 in the Overall Population Week 6 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.Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation Week 10 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.Percentage of Participants in Clinical Remission at Week 10 in the Overall Population Week 10 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.Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population Week 6 and Week 10 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.Number of Participants With Adverse Events (AEs) 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. 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?
Trial Locations
- Locations (41)
Atlanta Gastroenterology Associates
🇺🇸Atlanta, Georgia, United States
University of Kentucky Medical Center
🇺🇸Lexington, Kentucky, United States
Gastroenterology of the Rockies
🇺🇸Lafayette, Colorado, United States
Gastroenterology Center of Connecticut P.C.
🇺🇸Hamden, Connecticut, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Shafran Gastroenterology Center
🇺🇸Winter Park, Florida, United States
Gastroenterology Associates of Central Georgia
🇺🇸Macon, Georgia, United States
Atlanta Gastroenterology Specialist PC
🇺🇸Suwanee, Georgia, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University Of Louisville
🇺🇸Louisville, Kentucky, United States
Gastroenterology Associates
🇺🇸Baton Rouge, Louisiana, United States
Gastroenterology Research of New Orleans
🇺🇸Hammond, Louisiana, United States
Metropolitan Gastroenterology Group P.C.
🇺🇸Chevy Chase, Maryland, United States
Mid-Atlantic Medical Research Center
🇺🇸Hollywood, Maryland, United States
Massachusetts General Hospital Crohn's and Colitis Center
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Center for Digestive Health
🇺🇸Troy, Michigan, United States
Huron Gastroenterology Associates
🇺🇸Ypsilanti, Michigan, United States
Minnesota Gastroenterology P.A.
🇺🇸Plymouth, Minnesota, United States
Washington University
🇺🇸St. Louis, Missouri, United States
Long Island Clinical Research Associates
🇺🇸Great Neck, New York, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Options Health Research
🇺🇸Tulsa, Oklahoma, United States
Charlotte Gastroenterology and Hepatology P.L.L.C
🇺🇸Charlotte, North Carolina, United States
Consultants in Gastroenterology
🇺🇸Columbia, South Carolina, United States
Gastroenterology Center of the MidSouth PC
🇺🇸Germantown, Tennessee, United States
Digestive Health Specialists of Tyler
🇺🇸Tyler, Texas, United States
University of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Cotton O'Neil Digestive Health Center
🇺🇸Topeka, Kansas, United States
University of Rochester
🇺🇸Rochester, New York, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
Zeidler Ledcor Center-Univerisity of Alberta
🇨🇦Edmonton, Alberta, Canada
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Consultants for Clinical Research Inc.
🇺🇸Cincinnati, Ohio, United States
The Oregon Clinic-West Hills Gastroenterology
🇺🇸Portland, Oregon, United States
Gastroenterology Clinic of San Antonio
🇺🇸San Antonio, Texas, United States
University of Washington School of Medicine
🇺🇸Seattle, Washington, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
Medical College Of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States