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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01287897
Registration number
NCT01287897
Ethics application status
Date submitted
31/01/2011
Date registered
2/02/2011
Date last updated
21/01/2016
Titles & IDs
Public title
A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
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Scientific title
A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)
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Secondary ID [1]
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2010-023034-23
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Secondary ID [2]
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B0151003
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Universal Trial Number (UTN)
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Trial acronym
ANDANTE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's 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: Drugs - PF-04236921 SC injection
Treatment: Drugs - PF-04236921 SC injection
Treatment: Drugs - PF-04236921 SC injection
Placebo Comparator: Placebo- SC injection -
Experimental: Drug Dose level 1 - SC injection -
Experimental: Drug Dose level 2 - SC injection -
Treatment: Drugs: PF-04236921 SC injection
Placebo delivered SC, 2 doses separated by 4 weeks
Treatment: Drugs: PF-04236921 SC injection
Drug dose level 1 delivered SC, 2 doses separated by 4 weeks
Treatment: Drugs: PF-04236921 SC injection
Drug dose level 2 delivered SC, 2 doses separated by 4 weeks
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Intervention code [1]
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Treatment: Drugs
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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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The Crohn's Disease Activity Index (CDAI)-70 Response Rate at Week 8 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
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Assessment method [1]
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CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score greater than or equal to (>=) 0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
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Timepoint [1]
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Baseline and Week 8
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Primary outcome [2]
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The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mg
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Assessment method [2]
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CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 1, that will yield different estimates for placebo for the two different models.
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Timepoint [2]
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Baseline and Week 8
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Primary outcome [3]
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The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
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Assessment method [3]
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CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
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Timepoint [3]
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Baseline and Week 12
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Primary outcome [4]
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The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mg
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Assessment method [4]
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CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 3, that will yield different estimates for placebo for the two different models.
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Timepoint [4]
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Baseline and Week 12
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Secondary outcome [1]
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The CDAI-70 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
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Assessment method [1]
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CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
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Timepoint [1]
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Baseline and Weeks 2, 4, 6, and 10
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Secondary outcome [2]
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The CDAI-70 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
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Assessment method [2]
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CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 5, that will yield different estimates for placebo for the two different models.
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Timepoint [2]
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Baseline and Weeks 2, 4, 6, and 10
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Secondary outcome [3]
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The CDAI Remission Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
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Assessment method [3]
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CDAI remission rate was defined as an absolute CDAI score less than (<) 150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
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Timepoint [3]
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Baseline and Weeks 2, 4, 6, 8, 10, and 12
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Secondary outcome [4]
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The CDAI Remission Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
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Assessment method [4]
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CDAI remission rate was defined as an absolute CDAI score <150. The proportions of participants with CDAI remission were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 7, that will yield different estimates for placebo for the two different models.
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Timepoint [4]
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Baseline and Weeks 2, 4, 6, 8, 10, and 12
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Secondary outcome [5]
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The CDAI-100 Response Rate Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
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Assessment method [5]
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CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
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Timepoint [5]
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Baseline and Weeks 2, 4, 6, 8, 10, and 12
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Secondary outcome [6]
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The CDAI-100 Response Rate Over Time in Participants Who Received Placebo and PF-04236921 200 mg
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Assessment method [6]
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CDAI-100 response was defined as a decrease in CDAI score of 100 or greater from baseline. The proportions of participants with CDAI-100 response at Week 12 were compared between placebo and PF-04236921 200 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit. Many clinical trials use the endpoint for response as a 70 or greater point decrease in CDAI and clinical remission is often defined as a CDAI score below 150. The Outcome included a Generalized linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 9, that will yield different estimates for placebo for the two different models.
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Timepoint [6]
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Baseline and Weeks 2, 4, 6, 8, 10, and 12
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Secondary outcome [7]
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Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg
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Assessment method [7]
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CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference).
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Timepoint [7]
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0
Baseline and Weeks 2, 4, 6, 8, 10, and 12
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Secondary outcome [8]
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Change From Baseline in CDAI Score Over Time in Participants Who Received Placebo and PF-04236921 200 mg
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Assessment method [8]
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CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score >=0 and without an upper limit, and higher score indicate more severe disease. The Outcome included a Linear mixed model analyses which incorporated longitudinal data for each subject, and the same model is used for estimate (least squares mean) and statistical analysis (mean difference). Since the inputs in the model included different Analysis Population than in Outcome Measure 11, that will yield different estimates for placebo for the two different models.
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Timepoint [8]
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Baseline and Weeks 2, 4, 6, 8, 10, and 12
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Secondary outcome [9]
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Percentages of Participants With Confirmed Positive Anti-drug Antibodies (ADAs)
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Assessment method [9]
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The percentage of participants with confirmed positive ADA was summarized for each treatment arm. ADA positive was defined as ADA titer defined as ADA titer (ie, the reciprocal of the highest dilution that gives a value equivalent to the cut point of the assay) >= 4.32.
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Timepoint [9]
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At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40
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Secondary outcome [10]
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Percentages of Participants With Confirmed Positive Neutralizing Antibodies (NAbs)
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Assessment method [10]
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The percentage of participants with confirmed positive NAbs was summarized for each treatment arm. Only ADA positive samples were analyzed for Nab. A multi-tiered approach was utilized to detect NAbs. NAb serum samples were screened at tier one, and those found presumptively NAb positive was further tested with the confirmatory assay (tier two). The percentage of subjects with confirmed positive NAbs was summarized for each treatment.
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Timepoint [10]
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At baseline (Day 1) and at Weeks 4, 8, 12, 16, 24, 32 and 40
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Secondary outcome [11]
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Serum PF-04236921 Concentration Over Time
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Assessment method [11]
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Timepoint [11]
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Day 1 (predose), and at Weeks 2, 4 (Day 28, predose), 8, 10, 12, 16, 20, 24, 28, 32, 36, and 40
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Secondary outcome [12]
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Number of Participants Who Withdrew From the Study Due to Treatment-emergent Adverse Events (AEs)
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Assessment method [12]
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An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. Treatment-emergent were events between first dose of treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
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Timepoint [12]
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Induction period: from Week 0 (Day 1) through Week 12; follow-up period: from Week 12 (or discontinuation from the induction period) through last subject visit (up to 28 weeks after completion of or discontinuation from the 12-week induction period)
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Eligibility
Key inclusion criteria
- Subjects must have failed or are intolerant to anti TNFs
- hsCRP greater or equal to 5.0 mg/L
- Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed
within 8 weeks of study entry (screening) and able to retrospectively complete the
SES-CD or colonoscopy performed during screening
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Minimum age
18
Years
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Maximum age
75
Years
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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
- Pregnant or breastfeeding women
- Crohn's Disease with active fistulae or abscess
- History of diverticulitis or symptomatic diverticulosis
- Abnormality in hematology or chemistry profiles at 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
1/02/2011
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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
1/02/2015
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Sample size
Target
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Accrual to date
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Final
250
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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Nepean Public Hospital - Kingswood
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Recruitment hospital [3]
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Royal Brisbane and Women's Hospital - Herston, Brisbane
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Recruitment hospital [4]
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Mater Health Services - South Brisbane
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Recruitment hospital [5]
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Eastern Health, Box Hill Hospital - Box Hill
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Recruitment hospital [6]
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Monash Medical Centre - Clayton
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Recruitment hospital [7]
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The Royal Melbourne Hospital - Parkville
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Recruitment hospital [8]
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St. Vincent's Hospital Melbourne - Fitzroy
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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2747 - Kingswood
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Recruitment postcode(s) [3]
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4029 - Herston, Brisbane
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Recruitment postcode(s) [4]
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4101 - South Brisbane
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Recruitment postcode(s) [5]
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3128 - Box Hill
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Recruitment postcode(s) [6]
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3168 - Clayton
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Recruitment postcode(s) [7]
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3050 - Parkville
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Recruitment postcode(s) [8]
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VIC 3065 - Fitzroy
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Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Georgia
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United States of America
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Illinois
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Indiana
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Kentucky
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United States of America
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Maryland
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Massachusetts
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Michigan
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Belgium
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Vlaams Brabant
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Roeselare
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Brazil
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GO
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Brazil
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Brazil
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Brazil
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SP
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Brazil
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Hradec Kralove
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Czech Republic
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Olomouc
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Prague
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Usti nad Labem
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Aalborg
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Aarhus C
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Denmark
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Herlev
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Denmark
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Hvidovre
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Denmark
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Koebenhavn NV
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Denmark
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Koebenhavn
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Denmark
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Koege
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France
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Lille Cedex
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France
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Paris Cedex 12
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France
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Vandoeuvre Les Nancy
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Niedersachsen
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Germany
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Berlin
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Germany
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Hamburg
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Germany
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Kiel
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Germany
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Minden
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Germany
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Regensburg
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Greece
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Athens
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Greece
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Kolonaki Athens
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Szeged
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Hungary
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Szekszard
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Ireland
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Dublin 4
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Ireland
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Dublin
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Ireland
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Galway
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Israel
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Ramat Gan
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Israel
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Haifa
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Israel
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Holon
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petach Tikva
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Israel
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Tel Aviv
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Israel
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Zerifin
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Italy
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Foggia
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Italy
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Milano
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Italy
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Italy
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Italy
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Padova
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Italy
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Roma
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Auckland
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New Zealand
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Waikato
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New Zealand
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Wellington
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Romania
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Sector 2
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Switzerland
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Zuerich
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United Kingdom
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East Yorkshire
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United Kingdom
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Cambridge
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United Kingdom
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Glasgow
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United Kingdom
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Hull
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London
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United Kingdom
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Newcastle-upon-Tyne
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United Kingdom
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Summary
Brief summary
This is a proof of concept study to determine the efficacy and safety of a monoclonal
antibody with three doses versus placebo. Subjects will be randomized to a treatment and the
dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate
to severe refractory Crohn's Disease.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01287897
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01287897
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