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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02589665
Registration number
NCT02589665
Ethics application status
Date submitted
27/10/2015
Date registered
28/10/2015
Titles & IDs
Public title
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Ulcerative Colitis
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Scientific title
A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects With Moderate to Severe Ulcerative Colitis
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Secondary ID [1]
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I6T-MC-AMAC
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Secondary ID [2]
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15829
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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0
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: 50 mg Mirikizumab IV Q4W (Induction) - 50 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period. Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
Experimental: 200 mg Mirikizumab IV Q4W (induction) - 200 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
Experimental: 600 mg Mirikizumab IV Q4W (Induction) - 600 mg mirikizumab administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
Participants who do not have a clinical response may choose to participate in the unblinded study extension period.
Placebo comparator: Placebo IV Q4W (Induction) - Placebo administered every 4 weeks (Q4W) intravenously (IV) during the induction period.
Experimental: 200 mg Mirikizumab SC Q4W (Maintenance) - Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) Q4W during the maintenance period.
Experimental: 200 mg Mirikizumab SC Q12W (Maintenance) - Induction mirikizumab responders were re-randomized: 200 mg mirikizumab administered subcutaneously (SC) once every 12 weeks (Q12W) during the maintenance period.
Placebo comparator: Placebo SC Q4W (Maintenance) - Induction placebo responders: Placebo administered subcutaneously (SC) Q4W during the maintenance period.
Experimental: 600mg Mirikizumab IV Q4W Extension Open-Label - Induction non-responders: 600 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
Experimental: 1000mg Mirikizumab IV Q4W Extension Open-Label - Induction non-responders: 1000 mg mirikizumab administered intravenously (IV) once every 4 weeks (Q4W) during the Extension Open-Label.
Experimental: 200mg Mirikizumab SC Q4W Extension Open-Label - Extension Induction responders: 200 mg mirikizumab administered subcutaneously (SC) once every 4 weeks (Q4W) during the Extension Open-Label
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Induction Period: Percentage of Participants With Clinical Remission at Week 12
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Assessment method [1]
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Clinical remission at week 12 is a defined as achieving a 9-pt Mayo subscore for rectal bleeding=0, stool frequency=0 or 1 with = 1 point decrease from baseline, and endoscopy=0 or 1, excluding Physician's Global Assessment (PGA).
* Stool Frequency Subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal);
* Rectal Bleeding Subscore, based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed);
* Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration);
* Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from 0 (normal) to 3 (severe disease).
The total score ranges from 0 to 9 points, with higher scores representing more severe disease.
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Induction Period: Percentage of Participants With Clinical Response at Week 12
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Assessment method [1]
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Clinical response at week 12 is defined as a decrease in the 9-point Mayo subscores (rectal bleeding, stool frequency and the endoscopic findings) inclusive of \>= 2 points and \>=35% from baseline with either a decrease of rectal bleeding subscore of \>=1 or rectal bleeding subscore of 0 or 1.
The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:
* Stool Frequency Subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal);
* Rectal Bleeding Subscore, based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed);
* Endoscopy Subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
The total score ranges from 0 to 9 points, with higher scores representing more severe disease.
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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Induction Period: Percentage of Participants With Endoscopic Remission at Week 12
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Assessment method [2]
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Endoscopic remission at week 12 is defined as achieving a Mayo endoscopic score of 0 at Week 12. Endoscopy Subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration);
The total score ranges from 0 to 3 points, with higher scores representing more severe disease.
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Timepoint [2]
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0
Week 12
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Secondary outcome [3]
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Maintenance Period: Percentage of Participants With Endoscopic Remission at Week 52
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Assessment method [3]
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Endoscopic remission at week 52 is defined as achieving a Mayo endoscopic subscore of 0 at Week 52. Endoscopy Subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration);
The total score ranges from 0 to 3 points, with higher scores representing more severe disease.
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Timepoint [3]
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Week 52
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Secondary outcome [4]
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Induction Period: Change From Baseline to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
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Assessment method [4]
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The IBDQ is a 32-item subject-completed questionnaire that measures 4 aspects of subjects' lives: symptoms directly related to the primary bowel disturbance, systemic symptoms, emotional function, and social function (Guyatt et al. 1989). Responses are graded on a 7-point. Likert scale in which 7 denotes "not a problem at all" and 1 denotes "a very severe problem." Scores range from 32 to 224; a higher score indicates a better quality of life. LS Mean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Geographical Region + Prior Biologic Therapy Group (N) + Treatment + Time + Treatment\*Time (Type III sum of squares).
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Timepoint [4]
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Baseline, Week 12
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Secondary outcome [5]
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Induction Period: Change From Baseline to Week 12 in 36-Item Short Form Health Survey (SF-36)
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Assessment method [5]
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SF-36 Health Status Survey is a generic, health-related scale assessing participant's quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health. Domain scores: general health (range: 5-25); physical functioning (range: 10-30); role-physical (range: 4-8); role-emotional (range: 3-15); social functioning (range: 2-10); bodily pain (range: 2-12); vitality (range: 4-20); mental health (range: 5-25). Each raw scale score was converted to a scale score ranging from 0-100 points, with higher values representing a better outcome \[(Raw score) - min{raw score}\] / (max {raw score} - min{raw score}) x 100\]. LS Mean was calculated using Mixed effect Model Repeat Measurement (MMRM) model for post-baseline measures: Variable = Baseline + Geographical Region + Prior Biologic Therapy Group (N) + Treatment + Time + Treatment\*Time (Type III sum of squares).
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Timepoint [5]
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Baseline, Week 12
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Secondary outcome [6]
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Induction Period: Change From Baseline to Week 12 in Patient's Global Impressions of Severity (PGI-S) Score
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Assessment method [6]
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PGI-S is a 1-item subject-rated questionnaire designed to assess the subject's impression of their disease symptoms at baseline (Guy 1976; Yalcin and Bump 2003). Responses are graded on a 7-point scale in which a score of 1 indicates that the subject's symptom(s) are "normal," a score of 2 indicates that the subject feels "borderline ill," a score of 3 indicates that the subject feels "mildly ill," a score of 4 indicates that the subject(s) feel "moderately ill," and scores of 5, 6, and 7 indicate that the subject feels "markedly ill," "severely ill," and "extremely ill," respectively. LS Mean was calculated using MMRM model for post-baseline measures: Variable = Baseline + Geographical Region + Prior Biologic Therapy Group (N) + Treatment + Time + Treatment\*Time (Type III sum of squares).
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Timepoint [6]
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Baseline, Week 12
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Secondary outcome [7]
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Induction Period: Patient's Global Impressions of Improvement (PGI-I) Score at Week 12
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Assessment method [7]
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PGI-I scale is a subject-rated instrument designed to assess the subject's impression of change in their symptom(s) (Guy 1976; Yalcin and Bump 2003). Responses are graded on a 7-point Likert scale in which a score of 1 indicates that the subject's symptom(s) is "very much better," a score of 4 indicates that the subject's symptom(s) has experienced "no change," and a score of 7 indicates that the subject's symptom(s) is "very much worse."
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Timepoint [7]
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Week 12
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Secondary outcome [8]
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Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, Tau) of Mirikizumab
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Assessment method [8]
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Pharmacokinetics (PK): Area Under the Concentration-Time Curve During Dosing Interval at Steady State (AUCss, tau) of Mirikizumab
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Timepoint [8]
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Induction Period: Day (D) 1, D15 ± 2d, D29 ± 2d, D43 ± 2d, D57 ± 2d, D78-85; Maintenance Period: D85-92,D113± 7d,D141± 7d,D169± 7d,D225 ±7d,D281 ±7d,D337 ±7d,D393± 7d,D448± 7d,D504± 7d,D560± 7d,D616± 7d,D672± 7d,D728± 7d,D784± 7d,D840± 7d
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Secondary outcome [9]
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Induction Period: Percentage of Participants With Symptomatic Remission at Week 12
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Assessment method [9]
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Symptomatic remission is defined as a stool frequency score of 0 or 1 and a rectal bleeding score of 0.
* Stool Frequency Subscore is based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal).
* Rectal Bleeding Subscore is based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed).
The total score ranges from 0 to 1 points, with higher scores representing more severe disease.
The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100.
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Timepoint [9]
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Week 12
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Secondary outcome [10]
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Maintenance Period: Percentage of Participants With Symptomatic Remission at Week 52
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Assessment method [10]
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Symptomatic remission is defined as a stool frequency score of 0 or 1 and a rectal bleeding score of 0.
* Stool Frequency Subscore , based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal);
* Rectal Bleeding Subscore , based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed);
* Endoscopy Subscore , based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration);
* Physician's Global Assessment subscore, based on the physician's overall assessment, and scored from zero (normal) to 3 (severe disease).
The total score ranges from 0 to 1 points, with higher scores representing more severe disease.
The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100.
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Timepoint [10]
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Week 52
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Secondary outcome [11]
0
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Induction Period: Percentage of Participants With Endoscopic Improvement at Week 12
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Assessment method [11]
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Endoscopic Improvement defined as achieving an endoscopic findings subscore of 0 or 1. Endoscopy Subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100.
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Timepoint [11]
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Week 12
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Secondary outcome [12]
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0
Maintenance Period: Percentage of Participants With Endoscopic Improvement at Week 52
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Assessment method [12]
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Endoscopic Improvement defined as achieving an endoscopic findings subscore of 0 or 1. Endoscopy Subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The percentage of response is calculated by dividing number of participants in the specified category by number of participants with non-missing values multiplied by 100.
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Timepoint [12]
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Week 52
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Eligibility
Key inclusion criteria
* Have moderate to severe active UC as defined by a Mayo score of 6 to 12 with an endoscopic subscore =2 within 14 days before the first dose of study treatment (note: a partial Mayo score of at least 4 and other eligibility criteria must have been met before endoscopy is performed as a study procedure)
* Have evidence of UC extending proximal to the rectum (=15 centimeters [cm] of involved colon)
* Up-to-date colorectal cancer surveillance (performed according to local standard), for subjects with family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor
* Participants must either: be naive to biologic therapy (eg, tumor necrosis factor [TNF] antagonists or vedolizumab) and have at least 1 of the following: inadequate response or failure to tolerate current treatment with oral or intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine) or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC) OR have received treatment with 1 or more biologic agents (eg, TNF antagonists or vedolizumab) at doses approved for the treatment of UC with documented history of failure to respond to or tolerate such treatment
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Minimum age
18
Years
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Maximum age
75
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Have been diagnosed with indeterminate colitis, proctitis (distal disease involving the rectum only; less than 15 cm from the anal verge) or Crohn's Disease
* Have had surgery for treatment of UC or are likely to require surgery for UC during the study
* Have received any of the following for treatment of UC: cyclosporine or thalidomide within 30 days of screening, corticosteroid enemas, corticosteroid suppositories, or topical treatment with 5-aminosalicyclic acid within 30 days of screening
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/12/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
7/05/2019
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Sample size
Target
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Accrual to date
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Final
249
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Concord
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Recruitment hospital [2]
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0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Fitzroy
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Recruitment hospital [3]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - South Brisbane
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Recruitment hospital [4]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Woolloongabba
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Recruitment postcode(s) [1]
0
0
2139 - Concord
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Recruitment postcode(s) [2]
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3065 - Fitzroy
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Recruitment postcode(s) [3]
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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California
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United States of America
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Florida
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United States of America
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Illinois
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0
0
United States of America
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Louisiana
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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New York
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0
United States of America
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North Carolina
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United States of America
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Utah
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0
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Belgium
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Ghent
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0
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Belgium
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Leuven
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0
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Canada
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Calgary
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Canada
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Montreal
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0
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Canada
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Montréal
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0
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Czechia
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Hradec Kralove
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0
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Czechia
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Hradec Králové
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0
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Czechia
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Praha 4 Kralove
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Czechia
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Praha 4
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Czechia
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Praha
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Denmark
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Svendborg
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France
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Clichy
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France
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Montpellier Cedex 5
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France
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Nice
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France
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Saint Priest en Jarez
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France
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Vandoeuvre Les Nancy
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0
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Georgia
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Tbilisi
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Hungary
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Bekescsaba
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Hungary
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Budapest
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Hungary
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Szeged
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Hungary
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Szekszard
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Hungary
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Vac
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Japan
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Bunkyo-ku
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Japan
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Chuo-ku
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Kagoshima-shi
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Kamakura-shi
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Kasugai-shi
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Kawasaki
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Japan
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Mitaka
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Japan
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Nishinomiya
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Japan
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Oita City
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Japan
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Osaka-City
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Japan
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Saga-shi
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Japan
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Sakura
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Japan
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Shinjuku-ku
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Japan
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Takasaki
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Toyama
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Tsu-shi
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Japan
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Yokohama
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Moldova, Republic of
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Chisinau
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Netherlands
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Amsterdam
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Poland
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Bydgoszcz
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Poland
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Elblag
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Poland
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Katowice
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Krakow
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Lublin
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Rzeszow
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Poland
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Sopot
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Country [61]
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Poland
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State/province [61]
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Warszawa
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Country [62]
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Poland
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State/province [62]
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Wroclaw
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Country [63]
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Romania
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State/province [63]
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Bucharest
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Country [64]
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United Kingdom
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State/province [64]
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Oxford
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Country [65]
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United Kingdom
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State/province [65]
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Winchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eli Lilly and Company
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Ethics approval
Ethics application status
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Summary
Brief summary
The main purpose of this study is to test the hypothesis that treatment with mirikizumab is superior to placebo in providing clinical benefit to participants with moderate to severe ulcerative colitis (UC). This study will also investigate how the body processes the drug.
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Trial website
https://clinicaltrials.gov/study/NCT02589665
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Trial related presentations / publications
Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Hibi T, D'Haens GR, Tuttle JL, Krueger K, Friedrich S, Durante M, Arora V, Naegeli AN, Schmitz J, Feagan BG. Efficacy and Safety of Continued Treatment With Mirikizumab in a Phase 2 Trial of Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2022 Jan;20(1):105-115.e14. doi: 10.1016/j.cgh.2020.09.028. Epub 2020 Sep 18. Sandborn WJ, Ferrante M, Bhandari BR, Berliba E, Feagan BG, Hibi T, Tuttle JL, Klekotka P, Friedrich S, Durante M, Morgan-Cox M, Laskowski J, Schmitz J, D'Haens GR. Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Ulcerative Colitis. Gastroenterology. 2020 Feb;158(3):537-549.e10. doi: 10.1053/j.gastro.2019.08.043. Epub 2019 Sep 4.
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Public notes
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Contacts
Principal investigator
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
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Address
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Eli Lilly and Company
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Fax
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
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Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/65/NCT02589665/SAP_000.pdf
Study protocol
https://cdn.clinicaltrials.gov/large-docs/65/NCT02589665/Prot_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02589665