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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03464136
Registration number
NCT03464136
Ethics application status
Date submitted
7/03/2018
Date registered
13/03/2018
Date last updated
5/06/2023
Titles & IDs
Public title
Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year
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Scientific title
A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease
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Secondary ID [1]
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2017-004209-41
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Secondary ID [2]
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CR108449
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Universal Trial Number (UTN)
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Trial acronym
SEAVUE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Placebo for Ustekinumab
Treatment: Other - Placebo for Adalimumab
Treatment: Other - Ustekinumab (6 mg/kg)
Treatment: Other - Ustekinumab (90 mg)
Treatment: Other - Adalimumab (40 mg)
Experimental: Group 1 (Ustekinumab) - Participants will receive intravenous (IV) infusion of ustekinumab (approximately 6 milligram/kilogram \[mg/kg\]) and 4 subcutaneous (SC) injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants will self-administer one SC injection of ustekinumab 90 milligram (mg) every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated every 2 weeks (q2w) dosing intervals.
Active comparator: Group 2 (Adalimumab) - Participants will receive IV infusion of placebo for ustekinumab and 4 SC injections of adalimumab (each 40 mg, total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants will self-administer 1 SC injection of adalimumab 40 mg q2w.
Treatment: Other: Placebo for Ustekinumab
Participants will receive placebo as SC injection to blind adalimumab.
Treatment: Other: Placebo for Adalimumab
Participants will receive placebo as IV infusion to blind ustekinumab.
Treatment: Other: Ustekinumab (6 mg/kg)
Participants will receive ustekinumab 6 mg/kg (weight based dosing) as IV infusion.
Treatment: Other: Ustekinumab (90 mg)
Participants will self-administer SC injection of ustekinumab 90 mg.
Treatment: Other: Adalimumab (40 mg)
Participants will self-administer multiple SC injections of adalimumab (each 40 mg) and will receive total dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg q2w from Week 4 to 56.
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Intervention code [1]
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Treatment: Other
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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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Percentage of Participants With Clinical Remission at Week 52
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Assessment method [1]
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Percentage of participants with clinical remission at Week 52 were assessed. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of less than (\<) 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.
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Timepoint [1]
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Week 52
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Secondary outcome [1]
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Percentage of Participants With Corticosteroid-free Remission at Week 52
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Assessment method [1]
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Percentage of participants with Corticosteroid-free remission at Week 52 were assessed. Corticosteroid-free remission was defined as CDAI score \<150 points at Week 52 and not taking any corticosteroids for at least 30 days prior to Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.
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Timepoint [1]
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Week 52
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Secondary outcome [2]
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Percentage of Participants With Clinical Response at Week 52
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Assessment method [2]
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Percentage of participants with clinical response at Week 52 were assessed. Clinical response at Week 52 was defined as a reduction from baseline in the CDAI score of greater than or equal (\>=) 100 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.
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Timepoint [2]
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Week 52
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Secondary outcome [3]
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Percentage of Participants in Patient Reported Outcome (PRO)-2 Symptom Remission at Week 52
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Assessment method [3]
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PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools (total number of soft/liquid stools in the last 7 days) and abdominal pain (on a 4-point scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe). A weekly score was calculated for the liquid or soft stool frequency and a separate weekly score was calculated for abdominal pain, in each case based on daily symptom reporting. PRO-2 symptom remission was defined as an abdominal pain (AP) mean daily score at or below 1 and also stool frequency (SF) mean daily score at or below 3, that is, AP \<=1 and SF \<=3. PRO2 is a composite index consisting of weighted scoring of both variables. PRO-2 scores range from 0 to no upper limit with higher scores indicating 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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Percentage of Participants With Clinical Remission at Week 16
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Assessment method [4]
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Percentage of participants with clinical remission (defined as CDAI \<150 points) at Week 16 were assessed. Clinical remission was defined as a CDAI score of \< 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.
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Timepoint [4]
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Week 16
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Secondary outcome [5]
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Percentage of Participants With Endoscopic Remission at Week 52
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Assessment method [5]
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Percentage of participants with endoscopic remission at Week 52 were assessed. Endoscopic remission was defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score less than or equal to (\<=) 3, or SES-CD =0 for participants who entered the study with a SES-CD =3 at Week 52. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis) each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.
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Timepoint [5]
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Week 52
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Secondary outcome [6]
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Percentage of Participants With Clinical Remission Through Week 52
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Assessment method [6]
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Percentage of participants with clinical remission at each postbaseline visit through Week 52 were reported. Clinical remission was defined as a CDAI score of \<150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.
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Timepoint [6]
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Weeks 2, 8, 16, 24, 32, 40, 48, and 52
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Secondary outcome [7]
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Percentage of Participants With Clinical Response Through Week 52
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Assessment method [7]
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Percentage of participants with clinical response at each postbaseline visit through Week 52 were reported. Clinical response through Week 52 was defined as a reduction from baseline in the CDAI score of \>=100 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.
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Timepoint [7]
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Weeks 2, 8, 16, 24, 32, 40, 48, and 52
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Secondary outcome [8]
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Percentage of Participants With Durable Clinical Response at Week 52
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Assessment method [8]
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Percentage of participants with durable clinical response at Week 52 were reported. Durable clinical response was defined as CDAI score decreased at least 100 from baseline or CDAI \<150 at Week 52 and was \>= 80% of all visits between Week 16 and Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.
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Timepoint [8]
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Week 52
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Secondary outcome [9]
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Percentage of Participants With Durable Clinical Remission at Week 52
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Assessment method [9]
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Percentage of participants with durable clinical remission at Week 52 were reported. Clinical remission was defined as CDAI score \<150 at Week 52 and was \>= 80% of all visits between Week 16 and Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.
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Timepoint [9]
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Week 52
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Secondary outcome [10]
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Percentage of Participants With Abdominal Pain (AP) Improvement Through Week 52
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Assessment method [10]
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Percentage of participants with AP improvement through Week 52 were reported. AP improvement was defined as at least 1 point or greater improvement in mean daily CDAI AP score (ranges from 0 to 3 where higher score indicates severity of pain) from baseline, or a mean score of zero among participants with mean AP\>0 at baseline, compared at each visit through Week 52.
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Timepoint [10]
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Weeks 2, 8, 16, 24, 32, 40, 48, and 52
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Secondary outcome [11]
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Percentage of Participants With Reduction in Frequency of Diarrhea Through Week 52
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Assessment method [11]
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Number of participants with reduction in frequency of diarrhea were reported. Reduction in frequency of diarrhea was defined as a reduction of at least 3 (or a mean number \<1) in SF (that is, mean daily number of liquid or very soft stools from CDAI score \[ranges from 0 to 3 where higher score indicates severity of pain\] in the week prior to the visit) from baseline, among subjects with mean SF \>1 at baseline, compared at each visit through Week 52.
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Timepoint [11]
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Weeks 2, 8, 16, 24, 32, 40, 48, and 52
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Secondary outcome [12]
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Percentage of Participants With Clinical and Biomarker Remission at Weeks 8, 16 and 52
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Assessment method [12]
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Percentage of participants with clinical and biomarker remission was defined as the percentage of participants with CDAI \<150, CRP \<= 3 mg/L, and also fecal calprotectin \<=250 micrograms per gram (mcg/g). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.
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Timepoint [12]
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At Weeks 8, 16 and 52
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Secondary outcome [13]
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Percentage of Participants With Adverse Events (AEs)
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Assessment method [13]
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Percentage of participants with AE were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
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Timepoint [13]
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Up to Week 52 and up to Week 76
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Secondary outcome [14]
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Percentage of Participants With Infections
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Assessment method [14]
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Percentage of participants with infections were reported.
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Timepoint [14]
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Up to Week 52 and up to Week 76
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Secondary outcome [15]
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Percentage of Participants With Serious Infections
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Assessment method [15]
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Percentage of participants with serious infections were reported.
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Timepoint [15]
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Up to Week 52 and up to Week 76
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Secondary outcome [16]
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Percentage of Participants With Serious Adverse Events (SAEs)
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Assessment method [16]
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Percentage of participants with SAEs were reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Coronavirus disease 2019 (COVID-19) related adverse events are adverse events with any of the following preferred terms "COVID-19", "Asymptomatic COVID-19", "Suspected COVID-19", "COVID-19 pneumonia", "severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test positive" or with a reported term containing the string "COVI.
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Timepoint [16]
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Up to Week 52 and up to Week 76
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Secondary outcome [17]
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Percentage of Participants With Anti-drug Antibodies
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Assessment method [17]
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Percentage of participants with anti-drug antibodies were reported. Serum samples were assessed for anti-drug antibodies. Anti-drug assays were performed for ustekinumab and adalimumab.
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Timepoint [17]
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Up to Week 52
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Eligibility
Key inclusion criteria
* Has Crohn's Disease (CD) or fistulizing CD of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy
* Has moderately-to-severely active CD with a baseline Crohn's disease activity index (CDAI) score of greater than or equal to (>=) 220 and less than or equal to (<=) 450
* Has one or more ulceration on screening ileocolonoscopy (which by definition, would result in an Simple Endoscopic Score for Crohn's Disease [SES-CD] of at least 3)
* Has failed or was intolerant to conventional therapy (corticosteroids, azathioprine [AZA], 6-mercaptopurine [6-MP] and/or methotrexate [MTX]) at adequate doses or is corticosteroid dependent
* Has not previously received an approved biologic for Crohn's Disease (i.e., infliximab, adalimumab, certolizumab pegol, ustekinumab, natalizumab, vedolizumab or approved biosimilars of these agents)
* Participants on oral corticosteroids (e.g., prednisone, budesonide) at a prednisone-equivalent dose of <=40 or milligram/day (mg/day) or <=9 mg/day of budesonide are budesonide <=9 mg/day are permitted if doses are stable for 3 weeks prior to baseline
* Participants on AZA, 6-MP, or MTX at screening (or recently prior), must discontinue these medications at least 3 weeks prior to baseline
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Minimum age
18
Years
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Maximum age
No limit
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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
* Has complications of CD that are likely to require surgery or would confound the ability to assess the effect of ustekinumab or adalimumab treatment using the CDAI, such as: active stoma; short-gut syndrome and severe or symptomatic strictures or stenosis
* Currently has, or is suspected to have, an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks prior to baseline, or 8 weeks prior for intra-abdominal abscesses, if there is no anticipated need for any further surgery. Participants with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses present
* Has had any kind of bowel resection within 6 months prior to baseline or other intra-abdominal surgery or a hospital admission for bowel obstruction within 3 months prior to baseline
* Has a stool culture or other examination positive for an enteric pathogen, including Clostridium difficile toxin, in the last 4 months unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen
* Has received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or any other live bacterial or live viral vaccination within 2 weeks of baseline
* Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (eg, recurrent pyelonephritis or chronic nonremitting cystitis), or infected skin wounds or ulcers
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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 administering the treatment/s
The people assessing the outcomes
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 3
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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
29/03/2018
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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
21/05/2021
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Sample size
Target
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Accrual to date
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Final
386
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Monash Health, Monash Medical Centre - Clayton
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Alfred Hospital - Melbourne
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Mater Hospital Brisbane (Inflammatory Bowel Diseases) - South Brisbane
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St John of God Subiaco Hospital - Subiaco
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The Queen Elizabeth Hospital - Woodville South
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3168 - Clayton
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3004 - Melbourne
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4101 - South Brisbane
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Recruitment postcode(s) [4]
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6008 - Subiaco
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Recruitment postcode(s) [5]
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5011 - Woodville South
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Recruitment outside Australia
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United States of America
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Alabama
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California
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Colorado
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Connecticut
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Idaho
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Louisiana
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Pleven
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Amiens
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France
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France
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Nantes
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France
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Paris
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France
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Saint Priest en jarez
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France
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Toulouse
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Germany
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Freiburg
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Italy
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Ufa
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United Kingdom
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Bath
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London
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Southampton
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Taunton
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Funding & Sponsors
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Commercial sector/industry
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Name
Janssen Scientific Affairs, LLC
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Ethics approval
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Summary
Brief summary
The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.
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Trial website
https://clinicaltrials.gov/study/NCT03464136
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Trial related presentations / publications
Sands BE, Irving PM, Hoops T, Izanec JL, Gao LL, Gasink C, Greenspan A, Allez M, Danese S, Hanauer SB, Jairath V, Kuehbacher T, Lewis JD, Loftus EV Jr, Mihaly E, Panaccione R, Scherl E, Shchukina OB, Sandborn WJ; SEAVUE Study Group. Ustekinumab versus adalimumab for induction and maintenance therapy in biologic-naive patients with moderately to severely active Crohn's disease: a multicentre, randomised, double-blind, parallel-group, phase 3b trial. Lancet. 2022 Jun 11;399(10342):2200-2211. doi: 10.1016/S0140-6736(22)00688-2.
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Public notes
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Contacts
Principal investigator
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Janssen Scientific Affairs, LLC Clinical Trial
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Address
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Janssen Scientific Affairs, LLC
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/36/NCT03464136/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/36/NCT03464136/SAP_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/NCT03464136
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