Clinical trial NCT01224171: Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-10-19
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 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

Primary outcomes:
measure: Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation
timeFrame: Week 6
Secondary outcomes:
measure: Percentage of Participants in Clinical Remission at Week 6 in the Overall Population
timeFrame: Week 6
measure: Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation
timeFrame: Week 10
measure: Percentage of Participants in Clinical Remission at Week 10 in the Overall Population
timeFrame: Week 10
measure: Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population
timeFrame: Week 6 and Week 10
measure: Percentage of Participants With Sustained Clinical Remission in the Overall Population
timeFrame: Week 6 and Week 10
measure: Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation
timeFrame: Baseline and Week 6
measure: Number of Participants With Adverse Events (AEs)
timeFrame: 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.
Other outcomes:
Locations:
city: Lafayette
country: United States
facility: Gastroenterology of the Rockies
state: Colorado
city: Hamden
country: United States
facility: Gastroenterology Center of Connecticut P.C.
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia
state: Georgia
city: Suwanee
country: United States
facility: Atlanta Gastroenterology Specialist PC
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Topeka
country: United States
facility: Cotton O'Neil Digestive Health Center
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Louisville
country: United States
facility: University Of Louisville
state: Kentucky
city: Baton Rouge
country: United States
facility: Gastroenterology Associates
state: Louisiana
city: Hammond
country: United States
facility: Gastroenterology Research of New Orleans
state: Louisiana
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group P.C.
state: Maryland
city: Hollywood
country: United States
facility: Mid-Atlantic Medical Research Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital Crohn's and Colitis Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: Ypsilanti
country: United States
facility: Huron Gastroenterology Associates
state: Michigan
city: Plymouth
country: United States
facility: Minnesota Gastroenterology P.A.
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology and Hepatology P.L.L.C
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research Inc.
state: Ohio
city: Tulsa
country: United States
facility: Options Health Research
state: Oklahoma
city: Portland
country: United States
facility: The Oregon Clinic-West Hills Gastroenterology
state: Oregon
city: Columbia
country: United States
facility: Consultants in Gastroenterology
state: South Carolina
city: Germantown
country: United States
facility: Gastroenterology Center of the MidSouth PC
state: Tennessee
city: San Antonio
country: United States
facility: Gastroenterology Clinic of San Antonio
state: Texas
city: Tyler
country: United States
facility: Digestive Health Specialists of Tyler
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Seattle
country: United States
facility: University of Washington School of Medicine
state: Washington
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College Of Wisconsin
state: Wisconsin
city: Edmonton
country: Canada
facility: Zeidler Ledcor Center-Univerisity of Alberta
state: Alberta
Study officials:
affiliation: Millennium Pharmaceuticals, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Sands BE, Van Assche G, Tudor D, Akhundova-Unadkat G, Curtis RI, Tan T. Vedolizumab in Combination With Corticosteroids for Induction Therapy in Crohn's Disease: A Post Hoc Analysis of GEMINI 2 and 3. Inflamm Bowel Dis. 2019 Jul 17;25(8):1375-1382. doi: 10.1093/ibd/izy384.
citation: Feagan BG, Sandborn WJ, Colombel JF, Byrne SO, Khalid JM, Kempf C, Geransar P, Bhayat F, Rubin DT. Incidence of Arthritis/Arthralgia in Inflammatory Bowel Disease with Long-term Vedolizumab Treatment: Post Hoc Analyses of the GEMINI Trials. J Crohns Colitis. 2019 Jan 1;13(1):50-57. doi: 10.1093/ecco-jcc/jjy125.
citation: Feagan BG, Lasch K, Lissoos T, Cao C, Wojtowicz AM, Khalid JM, Colombel JF. Rapid Response to Vedolizumab Therapy in Biologic-Naive Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2019 Jan;17(1):130-138.e7. doi: 10.1016/j.cgh.2018.05.026. Epub 2018 May 29.
citation: Colombel JF, Sands BE, Rutgeerts P, Sandborn W, Danese S, D'Haens G, Panaccione R, Loftus EV Jr, Sankoh S, Fox I, Parikh A, Milch C, Abhyankar B, Feagan BG. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut. 2017 May;66(5):839-851. doi: 10.1136/gutjnl-2015-311079. Epub 2016 Feb 18.
citation: Rosario M, Dirks NL, Gastonguay MR, Fasanmade AA, Wyant T, Parikh A, Sandborn WJ, Feagan BG, Reinisch W, Fox I. Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn's disease. Aliment Pharmacol Ther. 2015 Jul;42(2):188-202. doi: 10.1111/apt.13243. Epub 2015 May 20.
citation: Sands BE, Feagan BG, Rutgeerts P, Colombel JF, Sandborn WJ, Sy R, D'Haens G, Ben-Horin S, Xu J, Rosario M, Fox I, Parikh A, Milch C, Hanauer S. Effects of vedolizumab induction therapy for patients with Crohn's disease in whom tumor necrosis factor antagonist treatment failed. Gastroenterology. 2014 Sep;147(3):618-627.e3. doi: 10.1053/j.gastro.2014.05.008. Epub 2014 May 21.