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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1156-8422 | Registry Identifier | WHO | |
| 2008-002782-32 | EudraCT Number | ||
| NL25207.096.08 | Registry Identifier | CCMO | |
| CTRI/2009/091/000128 | Registry Identifier | CTRI | |
| NMRR-08-1046-2201 | Registry Identifier | NMRR | |
| C13006CTIL | Other Identifier | Israel MoH | |
| 09/H1102/66 | Registry Identifier | NRES |
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The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.
This multicenter, phase 3, randomized, blinded, placebo-controlled study in patients with moderately to severely active ulcerative colitis comprises two phases:
The 6-week Induction Phase contained 2 cohorts of participants: Cohort 1 participants were randomized and treated with double-blind study drug, and Cohort 2 participants were treated with open-label vedolizumab. The second cohort was enrolled to ensure that the sample size of Induction Phase responders randomized into the Maintenance Study provided sufficient power for the Maintenance Study primary efficacy analysis. These participants did not contribute to the efficacy analyses performed for the Induction Study. Participants in both cohorts were assessed for treatment response at Week 6.
In the Maintenance Phase vedolizumab-treated participants from both Cohort 1 and Cohort 2 who demonstrated a clinical response were randomized in a 1:1:1 ratio to double-blind treatment with vedolizumab administered every 4 weeks (Q4W), vedolizumab administered every 8 weeks (Q8W), or placebo. Vedolizumab-treated participants who did not demonstrate response at Week 6 continued treatment with open-label vedolizumab, administered Q4W. Participants treated with double-blind placebo in the Induction Phase continued on double-blind placebo during the Maintenance Phase, regardless of treatment response during induction. The Maintenance Phase began at Week 6 and concluded with Week 52 assessments.
After the Week 52 assessments, participants meeting protocol-defined criteria were eligible to enroll in Study C13008 (NCT00790933; Long-term Safety) to receive open-label vedolizumab treatment. Participants who withdrew early (prior to Week 52) due to sustained nonresponse, disease worsening, or the need for rescue medications may also have been eligible for Study C13008. Participants who did not enroll into Study C13008 were to complete a final on-study safety assessment at Week 66 (or final safety visit 16 weeks after the last dose) in the Maintenance Phase of Study C13006.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vedolizumab | Experimental | In the Induction Phase participants received vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 (Days 1 and 15). In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria were randomized in a 1:1:1 ratio to double-blind treatment with vedolizumab administered every 4 weeks, vedolizumab administered every 8 weeks, or placebo for up to Week 50. Participants who did not demonstrate response at Week 6 of the Induction Phase continued treatment with vedolizumab, administered every 4 weeks during the Maintenance Phase. |
|
| Placebo | Placebo Comparator | In the Induction Phase participants received placebo intravenous infusion at Week 0 and Week 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vedolizumab | Drug | Vedolizumab for intravenous infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Induction Phase: Percentage of Participants With a Clinical Response at Week 6 | Clinical response is defined as a reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity). All participants who prematurely discontinued for any reason were considered as not achieving clinical response. | Baseline and Week 6 |
| Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 | Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity). All participants who prematurely discontinued for any reason were considered as not achieving clinical remission. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Induction Phase: Percentage of Participants in Clinical Remission at Week 6 | Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity). All participants who prematurely discontinued for any reason were considered as not achieving clinical remission. |
Not provided
Inclusion Criteria:
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
Diagnosis of moderately to severely active ulcerative colitis
Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance at least 1 of the following agents:
May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Apex Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23964932 | Result | Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, Van Assche G, Axler J, Kim HJ, Danese S, Fox I, Milch C, Sankoh S, Wyant T, Xu J, Parikh A; GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013 Aug 22;369(8):699-710. doi: 10.1056/NEJMoa1215734. | |
| 35934286 |
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In Cohort 1, eligible patients who met entry criteria were randomized to treatment with double-blind vedolizumab 300 mg or placebo in a 3:2 ratio. All Cohort 2 patients were treated with open-label vedolizumab. In the Maintenance Phase participants were assigned to treatment groups based on their Induction Phase treatment and response to therapy.
Participants took part in the study at 211 investigative sites worldwide. The Induction Phase contained 2 cohorts. The eligibility criteria for both cohorts were identical. The purpose of Cohort 2 was to provide enough responders to power the Maintenance Phase primary efficacy analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction Phase |
|
Not provided
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| Placebo | Other | Placebo intravenous infusion |
|
| Week 6 |
| Induction Phase: Percentage of Participants With Mucosal Healing at Week 6 | Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). All participants who prematurely discontinued for any reason were considered as not achieving mucosal healing. | Week 6 |
| Maintenance Phase: Percentage of Participants With Durable Clinical Response | Durable clinical response is defined as reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity). All participants who prematurely discontinued for any reason were considered as not achieving durable clinical response. | Baseline, Week 6 and Week 52 |
| Maintenance Phase: Percentage of Participants With Mucosal Healing at Week 52 | Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). All participants who prematurely discontinued for any reason were considered as not achieving mucosal healing. | Week 52 |
| Maintenance Phase: Percentage of Participants With Durable Clinical Remission | Durable clinical remission is defined as complete Mayo score of ≤ 2 points and no individual subscore > 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity). All participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission. | Week 6 and Week 52 |
| Maintenance Phase: Percentage of Participants With Corticosteroid-free Remission at Week 52 | Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point. Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission at Week 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity). All participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free remission. | Week 52 |
| Birmingham |
| Alabama |
| 35234 |
| United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Gastrointestinal Bioscience | Los Angeles | California | 90067 | United States |
| Paramount Medical Specialty | Montebello | California | 90640 | United States |
| Capital Gastroenterology Consultants Medical Group | Sacramento | California | 95815 | United States |
| Clinical Applications Laboratories Inc. | San Diego | California | 92103 | United States |
| Desta Digestive Disease Medical Center | San Diego | California | 92114 | United States |
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | United States |
| Gastroenterology of the Rockies | Lafayette | Colorado | 80026 | United States |
| Rocky Mountain Gastroenterology Associates P.L.L.C. | Lakewood | Colorado | 80215 | United States |
| Arapahoe Gastroenterology Associates P.C | Littleton | Colorado | 80120 | United States |
| South Denver Gastroenterology | Lone Tree | Colorado | 80124 | United States |
| Lynn Institute of Pueblo | Pueblo | Colorado | 81007 | United States |
| Gastroenterology Center of Connecticut, P.C. | Hamden | Connecticut | 06518 | United States |
| University of Florida | Gainesville | Florida | 32608 | United States |
| University of Florida, Jacksonville | Jacksonville | Florida | 32209 | United States |
| East Coast Institute for Research | Jacksonville | Florida | 32223 | United States |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | United States |
| Osler Clinical Research | Melbourne | Florida | 32901 | United States |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
| United Medical Research Institute | New Smyrna Beach | Florida | 32168 | United States |
| Compass Research LLC | Orlando | Florida | 32806 | United States |
| Internal Medicine Specialists | Orlando | Florida | 32806 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| West Wind'r Research & Development, LLC | Tampa | Florida | 33607 | United States |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | United States |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | United States |
| Southeast Regional Research Group | Columbus | Georgia | 31904 | United States |
| Atlanta Center for Gastroenterology, P.C. | Decatur | Georgia | 30033 | United States |
| Gastroenterology Associates of Central Georgia | Macon | Georgia | 31201 | United States |
| Digestive Research Associates | Newnan | Georgia | 30263 | United States |
| St. Joseph's/Candler Health System | Savannah | Georgia | 31405 | United States |
| DLW Research System | Snellville | Georgia | 30039 | United States |
| Carle Clinic Association P.C. | Urbana | Illinois | 61801 | United States |
| Digestive & Liver Consultants | Clive | Iowa | 50325 | United States |
| Iowa Digestive Disease Center | Clive | Iowa | 50325 | United States |
| University Of Kansas | Kansas City | Kansas | 66160 | 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 | 40202 | United States |
| Gastroenterology Associates | Baton Rouge | Louisiana | 70809 | United States |
| University of Maryland Medical Group | Baltimore | Maryland | 21201 | United States |
| Metropolitan Gastroenterology Group, P.C. | Chevy Chase | Maryland | 20815 | United States |
| Shah Associates | Prince Frederick | Maryland | 20678 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| The Center for Clinical Studies | Dearborn | Michigan | 48124 | United States |
| Center for Digestive Health | Troy | Michigan | 48098 | United States |
| Gastroenterology Associates of Western Michigan, P.L.C. | Wyoming | Michigan | 49519 | United States |
| Minnesota Gastroenterology, P.A. | Plymouth | Minnesota | 55486 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Truman Medical Center | Kansas City | Missouri | 64108 | United States |
| Center for Digestive and Liver Diseases, Inc. | Mexico | Missouri | 65265 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| St. Louis Center for Clinical Research | St Louis | Missouri | 63128 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Affiliates in Gastroenterology PA | Morristown | New Jersey | 07960 | United States |
| University of Medicine and Dentistry of New Jersey-NJMS | New Brunswick | New Jersey | 08903 | United States |
| The Gastroenterology Group of South Jersey | Vineland | New Jersey | 08360 | United States |
| Hepatobiliary Associates of New York | Bayside | New York | 11358 | United States |
| Digestive Health Physician | Cheektowaga | New York | 14225 | United States |
| Long Island Clinical Research Associates | Great Neck | New York | 11021 | United States |
| Long Island Gastroenterology Group, P.C. | Merrick | New York | 11566 | United States |
| New York Presbyterian Hospital | New York | New York | 10021 | United States |
| Present Chapman Marion Steinlauf MD PC | New York | New York | 10028 | United States |
| Kim, Chung MD (Private Practice) | Pittsford | New York | 14534 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Long Island Digestive Disease Consultants | Setauket | New York | 11733 | United States |
| SUNY Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| Syracuse Gastroenterological Associates | Syracuse | New York | 13210 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Charlotte Gastroentology and Hepatology, P.L.L.C | Charlotte | North Carolina | 28207 | United States |
| Northwest Piedmont Clinical Research, Inc. | Elkin | North Carolina | 28621 | United States |
| Burke Research Associates | Morganton | North Carolina | 28655 | United States |
| Consultants for Clinical Research Inc. | Cincinnati | Ohio | 45219 | United States |
| Dayton Science Institute | Dayton | Ohio | 45415 | United States |
| Options Health Research | Tulsa | Oklahoma | 74104 | United States |
| The Oregon Clinic-West Hills Gastroenterology | Portland | Oregon | 97225 | United States |
| University of Pittsburgh Medical Center - Cancer Centers | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University Of SC CAR | Charleston | South Carolina | 29425 | United States |
| Gastroenterology Center of the MidSouth, PC | Germantown | Tennessee | 38138 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Austin Gastroenterology, PA | Austin | Texas | 78705 | United States |
| Bayou City Research, Ltd. | Houston | Texas | 77024 | United States |
| Baylor College Of Medicine | Houston | Texas | 77030 | United States |
| Gastroenterology Consultants | Houston | Texas | 77034 | United States |
| Jacon Medical Research Associates | Houston | Texas | 77090 | United States |
| Digestive Health Center | Pasadena | Texas | 77504 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Gastroenterology Clinic of San Antonio | San Antonio | Texas | 78229 | United States |
| Stone Oak Research Foundation | San Antonio | Texas | 78258 | United States |
| Digestive Health Specialists of Tyler | Tyler | Texas | 75701 | United States |
| Granite Peaks Gastroenterology | Sandy City | Utah | 84094 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Gastroenterology Associates of Northern Virginia | Fairfax | Virginia | 22031 | United States |
| Digestive and Liver Disease Specialist Ltd | Norfolk | Virginia | 23502 | United States |
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
| Puget Sound Medical Research | Edmonds | Washington | 98026 | United States |
| Pharmaseek, LLC | Madison | Wisconsin | 53717 | 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 |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Pharmaseek, LLC | Ponce | 716 | Puerto Rico |
| Dulai PS, Feagan BG, Sands BE, Chen J, Lasch K, Lirio RA. Prognostic Value of Fecal Calprotectin to Inform Treat-to-Target Monitoring in Ulcerative Colitis. Clin Gastroenterol Hepatol. 2023 Feb;21(2):456-466.e7. doi: 10.1016/j.cgh.2022.07.027. Epub 2022 Aug 4. |
| 33200296 | Derived | Wyant T, Yang L, Rosario M. Comparison of the ELISA and ECL Assay for Vedolizumab Anti-drug Antibodies: Assessing the Impact on Pharmacokinetics and Safety Outcomes of the Phase 3 GEMINI Trials. AAPS J. 2020 Nov 16;23(1):3. doi: 10.1208/s12248-020-00518-0. |
| 32635680 | Derived | Okamoto H, Dirks NL, Rosario M, Hori T, Hibi T. Population pharmacokinetics of vedolizumab in Asian and non-Asian patients with ulcerative colitis and Crohn's disease. Intest Res. 2021 Jan;19(1):95-105. doi: 10.5217/ir.2019.09167. Epub 2020 Jul 10. |
| 32606883 | Derived | Loftus EV Jr, Sands BE, Colombel JF, Dotan I, Khalid JM, Tudor D, Geransar P. Sustained Corticosteroid-Free Clinical Remission During Vedolizumab Maintenance Therapy in Patients with Ulcerative Colitis on Stable Concomitant Corticosteroids During Induction Therapy: A Post Hoc Analysis of GEMINI 1. Clin Exp Gastroenterol. 2020 Jun 11;13:211-220. doi: 10.2147/CEG.S248597. eCollection 2020. |
| 32062041 | Derived | Dulai PS, Singh S, Vande Casteele N, Meserve J, Winters A, Chablaney S, Aniwan S, Shashi P, Kochhar G, Weiss A, Koliani-Pace JL, Gao Y, Boland BS, Chang JT, Faleck D, Hirten R, Ungaro R, Lukin D, Sultan K, Hudesman D, Chang S, Bohm M, Varma S, Fischer M, Shmidt E, Swaminath A, Gupta N, Rosario M, Jairath V, Guizzetti L, Feagan BG, Siegel CA, Shen B, Kane S, Loftus EV Jr, Sandborn WJ, Sands BE, Colombel JF, Lasch K, Cao C. Development and Validation of Clinical Scoring Tool to Predict Outcomes of Treatment With Vedolizumab in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Dec;18(13):2952-2961.e8. doi: 10.1016/j.cgh.2020.02.010. Epub 2020 Feb 13. |
| 30365009 | Derived | Feagan BG, Schreiber S, Wolf DC, Axler JL, Kaviya A, James A, Curtis RI, Geransar P, Stallmach A, Ehehalt R, Bokemeyer B, Khalid JM, O'Byrne S. Sustained Clinical Remission With Vedolizumab in Patients With Moderate-to-Severe Ulcerative Colitis. Inflamm Bowel Dis. 2019 May 4;25(6):1028-1035. doi: 10.1093/ibd/izy323. |
| 30285104 | Derived | Sandborn WJ, Colombel JF, Panaccione R, Dulai PS, Rosario M, Cao C, Barocas M, Lasch K. Deep Remission With Vedolizumab in Patients With Moderately to Severely Active Ulcerative Colitis: A GEMINI 1 post hoc Analysis. J Crohns Colitis. 2019 Feb 1;13(2):172-181. doi: 10.1093/ecco-jcc/jjy149. |
| 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. |
| 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. |
| 27802155 | Derived | Arijs I, De Hertogh G, Lemmens B, Van Lommel L, de Bruyn M, Vanhove W, Cleynen I, Machiels K, Ferrante M, Schuit F, Van Assche G, Rutgeerts P, Vermeire S. Effect of vedolizumab (anti-alpha4beta7-integrin) therapy on histological healing and mucosal gene expression in patients with UC. Gut. 2018 Jan;67(1):43-52. doi: 10.1136/gutjnl-2016-312293. Epub 2016 Oct 7. |
| 27639327 | Derived | Feagan BG, Rubin DT, Danese S, Vermeire S, Abhyankar B, Sankoh S, James A, Smyth M. Efficacy of Vedolizumab Induction and Maintenance Therapy in Patients With Ulcerative Colitis, Regardless of Prior Exposure to Tumor Necrosis Factor Antagonists. Clin Gastroenterol Hepatol. 2017 Feb;15(2):229-239.e5. doi: 10.1016/j.cgh.2016.08.044. Epub 2016 Sep 14. |
| 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. |
| Induction Phase: DB Vedolizumab |
In the Induction Phase participants in Cohort 1 were randomized to receive double-blind (DB) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2. |
| FG002 | Induction Phase: OL Vedolizumab | In the Induction Phase participants in Cohort 2 received open-label (OL) vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2. |
| FG003 | Maintenance Phase: Placebo | Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with placebo every 4 weeks up to Week 50 during the Maintenance Phase. |
| FG004 | Maintenance Phase: Vedolizumab Q8W | Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 8 weeks (Q8W) at Weeks 6, 14, 22, 30, 38, and 46, and, to maintain blinding, placebo infusions at Weeks 10, 18, 26, 34, 42, and 50. |
| FG005 | Maintenance Phase: Vedolizumab Q4W | Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were then randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50. |
| FG006 | Maintenance Phase: Non-responders | Participants who received vedolizumab during the Induction Phase who did not demonstrate a clinical response at Week 6 received open-label treatment with vedolizumab 300 mg every 4 weeks from Week 6 to Week 50. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance Phase |
|
|
Baseline characteristics are provided for the Induction Phase Safety Population, defined as all participants, in both Cohort 1 and Cohort 2, who received any amount of study drug in the Induction Phase (Weeks 0-6), according to the actual study drug received.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | In the Induction Phase participants in Cohort 1 were randomized to receive double-blind placebo intravenous infusions at Week 0 and Week 2. Participants continued to receive placebo every 4 weeks from Week 6 through Week 50 during the Maintenance Phase, regardless of treatment response during induction. |
| BG001 | Induction Phase: DB Vedolizumab | In the Induction Phase participants in Cohort 1 were randomized to receive double-blind vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2. |
| BG002 | Induction Phase: OL Vedolizumab | In the Induction Phase participants in Cohort 2 received open-label vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2. |
| BG003 | 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Body Weight | Body weight data only available for 148 participants in the placebo arm. | Mean | Standard Deviation | kg |
| ||||||||||||||
| Body Mass Index (BMI) | BMI data only available for 148 participants in the placebo arm. | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Duration of Ulcerative Colitis | Duration of ulcerative colitis data only available for 519 participants in the Induction Phase: OL Vedolizumab arm. | Mean | Standard Deviation | years |
| ||||||||||||||
| Categorical Duration of Ulcerative Colitis | Number | participants |
| ||||||||||||||||
| Baseline Mayo Score | The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Baseline Disease Activity | Number | participants |
| ||||||||||||||||
| Baseline Fecal Calprotectin | Number of participants for whom baseline fecal calprotectin data were available were 139, 213, and 505, respectively. | Mean | Standard Deviation | μg/g |
| ||||||||||||||
| Categorical Baseline Fecal Calprotectin | Number | participants |
| ||||||||||||||||
| Disease Localization | Number | participants |
| ||||||||||||||||
| Smoking Status | Number | participants |
| ||||||||||||||||
| History of Extraintestinal Manifestations | 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 | Induction Phase: Percentage of Participants With a Clinical Response at Week 6 | Clinical response is defined as a reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity). All participants who prematurely discontinued for any reason were considered as not achieving clinical response. | Induction Study Intent-to-treat (ITT) population which consisted of all randomized patients in Cohort 1 who received any amount of blinded study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Week 6 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 | Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity). All participants who prematurely discontinued for any reason were considered as not achieving clinical remission. | Maintenance Study ITT Population, defined as all randomized participants who received vedolizumab during the Induction Phase and met the protocol definition of clinical response at Week 6, as assessed by the investigator, were randomized, and received any amount of double-blind study drug in the Maintenance Phase. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Induction Phase: Percentage of Participants in Clinical Remission at Week 6 | Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity). All participants who prematurely discontinued for any reason were considered as not achieving clinical remission. | Induction Study ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Week 6 |
|
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| Secondary | Induction Phase: Percentage of Participants With Mucosal Healing at Week 6 | Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). All participants who prematurely discontinued for any reason were considered as not achieving mucosal healing. | Induction Study ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Week 6 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance Phase: Percentage of Participants With Durable Clinical Response | Durable clinical response is defined as reduction in complete Mayo score of ≥ 3 points and ≥ 30% from Baseline (Week 0) with an accompanying decrease in rectal bleeding subscore of ≥ 1 point or absolute rectal bleeding subscore of ≤ 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity). All participants who prematurely discontinued for any reason were considered as not achieving durable clinical response. | Maintenance Study ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 6 and Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance Phase: Percentage of Participants With Mucosal Healing at Week 52 | Mucosal healing is defined as a Mayo endoscopic subscore of ≤ 1 point. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Endoscopic findings were scored on a scale from 0 to 3 as follows: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern, mild friability); 2 = Moderate disease (marked erythema, lack of vascular pattern, friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). All participants who prematurely discontinued for any reason were considered as not achieving mucosal healing. | Maintenance Study ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance Phase: Percentage of Participants With Durable Clinical Remission | Durable clinical remission is defined as complete Mayo score of ≤ 2 points and no individual subscore > 1 point at both Weeks 6 and 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity). All participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission. | Maintenance Study ITT Population | Posted | Number | 95% Confidence Interval | percentage of participants | Week 6 and Week 52 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maintenance Phase: Percentage of Participants With Corticosteroid-free Remission at Week 52 | Clinical Remission is defined as a complete Mayo score of ≤ 2 points and no individual subscore > 1 point. Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission at Week 52. The Mayo Score is a standard assessment tool to measure ulcerative colitis disease activity in clinical trials. The index consists of 4 components: two that are patient reported (rectal bleeding and stool frequency), a global assessment by the physician, and an endoscopic subscore. Each component is scored on a scale from 0 to 3 and the complete score ranges from 1 to 12 (higher scores indicate greater disease activity). All participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free remission. | Maintenance Study ITT Population, participants who were on corticosteroids at Baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 52 |
|
From the start of the Induction Phase until a final on-study safety assessment at Week 66 (or Final Safety visit 16 weeks after the last dose).
Not provided
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 who received double-blind placebo intravenous infusions in the Induction Phase and continued to receive placebo during the Maintenance Phase. | 17 | 149 | 67 | 149 | ||
| EG001 | Vedolizumab Then Placebo | Participants who received vedolizumab during the Induction Phase and were then randomized to receive placebo during the Maintenance Phase. | 20 | 126 | 69 | 126 | ||
| EG002 | Vedolizumab | Participants who received vedolizumab during the Induction Phase and continued to receive vedolizumab during the Maintenance Phase. This includes participants who had a clinical response at Week 6 and were randomized to vedolizumab every 4 weeks or every 8 weeks in the Maintenance Phase, participants who did not achieve a clinical response at Week 6 and continued to receive vedolizumab every 4 weeks for the duration of the study, and participants who withdrew during the Induction phase. | 77 | 620 | 321 | 620 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Peritoneal haemorrhage | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Colon dysplasia | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Cholangitis suppurative | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Pulpitis dental | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Pelvic abscess | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Pericoronitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Accidental poisoning | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Gastrointestinal stoma complication | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cholangitis sclerosing | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Tubulointerstitial nephritis | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Haemoglobin decrease | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (14.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Arteriosclerosis obliterans | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Menorrhagia | Reproductive system and breast disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (14.0) | Systematic Assessment |
| |
| Sarcoidosis | Immune system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Fatigue | 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 |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C543529 | vedolizumab |
| C438271 | LDP-02 |
Not provided
Not provided
Not provided
| Protocol Violation |
|
| Lack of Efficacy |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| ≥ 35 |
|
| ≥ 65 |
|
| Male |
|
| Black |
|
| Asian |
|
| Other |
|
| Not Hispanic or Latino |
|
| Not reported |
|
| Austria |
|
| Belgium |
|
| Bulgaria |
|
| Canada |
|
| Czech Republic |
|
| Denmark |
|
| Estonia |
|
| France |
|
| Germany |
|
| Greece |
|
| Hong Kong |
|
| Hungary |
|
| Iceland |
|
| India |
|
| Ireland |
|
| Israel |
|
| Italy |
|
| Korea, Republic of |
|
| Latvia |
|
| Malaysia |
|
| Netherlands |
|
| New Zealand |
|
| Norway |
|
| Poland |
|
| Russian Federation |
|
| Singapore |
|
| South Africa |
|
| Spain |
|
| Switzerland |
|
| Turkey |
|
| United Kingdom |
|
| United States |
|
| ≥1 - < 3 years |
|
| ≥ 3 - < 7 years |
|
| ≥ 7 years |
|
| Missing |
|
| Complete Mayo score of 6 to 8 (inclusive) |
|
| Complete Mayo score of 9 to 12 (inclusive) |
|
| > 250 to ≤ 500 μg/g |
|
| > 500 μg/g |
|
| Missing |
|
| Left-sided colitis |
|
| Extensive colitis |
|
| Pancolitis |
|
| Nonsmoker |
|
| Former smoker |
|
| No |
|
| OG002 | Vedolizumab Q4W | Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50. |
|
|
|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG002 | Vedolizumab Q4W | Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50. |
|
|
|
| OG002 | Vedolizumab Q4W | Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50. |
|
|
|
| OG002 | Vedolizumab Q4W | Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50. |
|
|
|
| OG002 | Vedolizumab Q4W | Participants who received vedolizumab during the Induction Phase and demonstrated a clinical response at Week 6 were randomized to receive double-blind treatment with vedolizumab 300 mg every 4 weeks (Q4W) from Week 6 to Week 50. |
|
|
|