Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1158-2581 | Registry Identifier | WHO | |
| 2009-016488-12 | EudraCT Number | ||
| NL34356.078.10 | Registry Identifier | CCMO |
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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.
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.
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received placebo intravenous infusion at Weeks 0, 2 and 6. |
|
| Vedolizumab | Experimental | Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vedolizumab | Drug | Vedolizumab for intravenous infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) 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:
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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. |
Not provided
Inclusion Criteria:
Exclusion Criteria
Not provided
Not provided
Not provided
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Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology of the Rockies | Lafayette | Colorado | 80026 | United States | ||
| Gastroenterology Center of Connecticut P.C. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30615117 | Derived | 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. | |
| 30203005 | Derived | 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. |
Not provided
Not provided
Participants were randomized 1:1 to receive either 300 mg vedolizumab or placebo. Randomization to treatment assignment was stratified by the presence or absence of previous failure of TNFα antagonist therapy or naïve to TNFα antagonist therapy, concomitant use of oral corticosteroids and concomitant use of immunomodulators.
Participants with moderately to severely active Crohn's Disease took part in the study at 107 sites worldwide from 24 November 2010 to 12 April 2012. Approximately 75% of participants were to have previously failed tumor necrosis factor alpha (TNFα) antagonist therapy and approximately 25% were to have been naïve to TNFα antagonist therapy.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo intravenous infusion at Weeks 0, 2 and 6. |
| FG001 | Vedolizumab | Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Placebo intravenous infusion |
|
| Week 6 |
| Percentage of Participants in Clinical Remission at Week 10 in the TNFα 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:
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 |
| 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:
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 |
| Percentage of Participants With Sustained Clinical Remission in the TNFα 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:
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 |
| 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:
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 |
| Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα 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:
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 |
| 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. |
| Hamden |
| Connecticut |
| 65180 |
| United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | United States |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | United States |
| Gastroenterology Associates of Central Georgia | Macon | Georgia | 31201 | United States |
| Atlanta Gastroenterology Specialist PC | Suwanee | Georgia | 30024 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
| Cotton O'Neil Digestive Health Center | Topeka | Kansas | 66606 | United States |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | United States |
| University Of Louisville | Louisville | Kentucky | 40402 | United States |
| Gastroenterology Associates | Baton Rouge | Louisiana | 70809 | United States |
| Gastroenterology Research of New Orleans | Hammond | Louisiana | 70403 | United States |
| Metropolitan Gastroenterology Group P.C. | Chevy Chase | Maryland | 20815 | United States |
| Mid-Atlantic Medical Research Center | Hollywood | Maryland | 20636 | United States |
| Massachusetts General Hospital Crohn's and Colitis Center | Boston | Massachusetts | 02114 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Center for Digestive Health | Troy | Michigan | 48098 | United States |
| Huron Gastroenterology Associates | Ypsilanti | Michigan | 48197 | United States |
| Minnesota Gastroenterology P.A. | Plymouth | Minnesota | 55446 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Long Island Clinical Research Associates | Great Neck | New York | 11021 | United States |
| New York Presbyterian Hospital | New York | New York | 10021 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Charlotte Gastroenterology and Hepatology P.L.L.C | Charlotte | North Carolina | 28207 | United States |
| Consultants for Clinical Research Inc. | Cincinnati | Ohio | 45219 | United States |
| Options Health Research | Tulsa | Oklahoma | 74104 | United States |
| The Oregon Clinic-West Hills Gastroenterology | Portland | Oregon | 97225 | United States |
| Consultants in Gastroenterology | Columbia | South Carolina | 29203 | United States |
| Gastroenterology Center of the MidSouth PC | Germantown | Tennessee | 38138 | United States |
| Gastroenterology Clinic of San Antonio | San Antonio | Texas | 78229 | United States |
| Digestive Health Specialists of Tyler | Tyler | Texas | 75701 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| University of Washington School of Medicine | Seattle | Washington | 98195 | United States |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53215 | United States |
| Medical College Of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Zeidler Ledcor Center-Univerisity of Alberta | Edmonton | Alberta | T6G2X8 | Canada |
| 29857145 | Derived | 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. |
| 26893500 | Derived | 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. |
| 25996351 | Derived | 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. |
| 24859203 | Derived | 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. |
| TNFα Antagonist Failure Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Overall Intent-to-treat (ITT) Population consisted of all randomized participants who received any amount of blinded study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo intravenous infusion at Weeks 0, 2 and 6. |
| BG001 | Vedolizumab | Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Body Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Geographic Region | Number | participants |
| ||||||||||||||||
| Duration of Crohn's Disease (CD) | Mean | Standard Deviation | years |
| |||||||||||||||
| Duration of Crohn's Disease - Categorical | Number | participants |
| ||||||||||||||||
| Baseline Disease Activity - Crohn's Disease Activity Index (CDAI) | Baseline disease activity represents the baseline CDAI score. The CDAI is a numerical calculation derived from the sum of products from a list of 8 disease variables: number of liquid stools, extent of abdominal pain, general well-being, occurrence of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal masses, hematocrit, and body weight. CDAI scores range from 0 to ~600 points with lower scores indicating disease remission and higher scores indicating disease worsening. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Baseline Disease Activity - Categorical | Number | participants |
| ||||||||||||||||
| C-reactive Protein (CRP) | Mean | Standard Deviation | mg/L |
| |||||||||||||||
| CRP - Categorical | Number | participants |
| ||||||||||||||||
| Fecal Calprotectin | Number of participants for whom baseline fecal calprotectin data were available were 206 and 204, respectively. | Mean | Standard Deviation | μg/g |
| ||||||||||||||
| Fecal Calprotectin - Categorical | Number | participants |
| ||||||||||||||||
| Disease Localization | Number | participants |
| ||||||||||||||||
| History of Prior Surgery for Crohn's Disease | Number | participants |
| ||||||||||||||||
| Smoking Status | Number | participants |
| ||||||||||||||||
| History of Fistulizing Disease | Number | participants |
| ||||||||||||||||
| Draining Fistula at Baseline | Number | participants |
| ||||||||||||||||
| Extraintestinal Manifestations at Baseline | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) 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:
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. | TNFα Antagonist Failure Intent-to-treat (ITT) subpopulation which consisted of all randomized participants who received any amount of blinded study drug who met the TNFα antagonist failure criterion. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 6 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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:
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. | Overall ITT population, consisting of all randomized participants who received any amount of blinded study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants in Clinical Remission at Week 10 in the TNFα 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:
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. | TNFα Antagonist Failure Intent-to-treat (ITT) Subpopulation | Posted | Number | 95% Confidence Interval | percentage of participants | Week 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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:
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. | Overall ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Week 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Clinical Remission in the TNFα 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:
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. | TNFα Antagonist Failure ITT Subpopulation | Posted | Number | 95% Confidence Interval | percentage of participants | Week 6 and Week 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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:
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. | Overall ITT population | Posted | Number | 95% Confidence Interval | percentage of participants | Week 6 and Week 10 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα 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:
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. | TNFα Antagonist Failure ITT Subpopulation | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 6 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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? | Overall Safety Population | Posted | Number | participants | 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. |
|
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.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants received placebo intravenous infusion at Weeks 0, 2 and 6. | 16 | 207 | 29 | 207 | ||
| EG001 | Vedolizumab | Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6. | 13 | 209 | 25 | 209 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's disease | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Ependymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Demyelination | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.0) | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Millennium Pharmaceuticals Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C543529 | vedolizumab |
| C438271 | LDP-02 |
Not provided
Not provided
Not provided
| ≥ 35 years |
|
| ≥ 65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black |
|
| Asian |
|
| Other |
|
| Not Reported |
|
| Western/Northern Europe |
|
| Central Europe |
|
| Eastern Europe |
|
| Asia/Australia/Africa |
|
| ≥ 1 to < 3 years |
|
| ≥ 3 to < 7 years |
|
| ≥ 7 years |
|
| CDAI > 330 |
|
| > 2.87 to ≤ 5 mg/L |
|
| > 5 to ≤ 10 mg/L |
|
| > 10 mg/L |
|
| > 250 to ≤ 500 μg/g |
|
| > 500 μg/g |
|
| Missing |
|
| Colon only |
|
| Ileocolonic (both ileum and colon) |
|
| No |
|
| Never Smoked |
|
| Former Smoker |
|
| No |
|
| All Closed |
|
| No Fistula |
|
| No |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|