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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00552058
Registration number
NCT00552058
Ethics application status
Date submitted
18/10/2007
Date registered
1/11/2007
Date last updated
9/08/2018
Titles & IDs
Public title
Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease
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Scientific title
Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease.
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Secondary ID [1]
0
0
2007-001913-41
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Secondary ID [2]
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0
C87085
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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:
Crohn Disease
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0
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Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
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Inflammatory bowel disease
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
0
0
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Crohn's disease
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Other - certolizumab pegol (CDP870, CZP)
Other interventions - Placebo
Experimental: Certolizumab pegol - Certolizumab pegol 400 mg for subcutaneous (sc) injection
Placebo comparator: Placebo - Placebo, saline solution for sc injection
Treatment: Other: certolizumab pegol (CDP870, CZP)
Certolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4
Other interventions: Placebo
Saline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Other interventions
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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 Subjects in Clinical Remission at Week 6
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Assessment method [1]
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The percentage of subjects in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
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Timepoint [1]
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Week 6
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Secondary outcome [1]
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Percentage of Subjects Achieving a Clinical Response at Week 6
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Assessment method [1]
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The percentage of subjects achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
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Timepoint [1]
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Week 0, Week 6
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Secondary outcome [2]
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Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6
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Assessment method [2]
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The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 6 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
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Timepoint [2]
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Week 6
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Secondary outcome [3]
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Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6
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Assessment method [3]
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The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 6. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
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Timepoint [3]
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Week 0 to Week 6
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Secondary outcome [4]
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Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6
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Assessment method [4]
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The change in Harvey Bradshaw Index (HBI) score from Week 0 to Week 6. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (score 1 per item). The first three items are scored for the previous day. Lower scores indicated better well being.
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Timepoint [4]
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0
Week 0 to Week 6
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Secondary outcome [5]
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Percentage of Subjects in Clinical Remission at Week 2
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Assessment method [5]
0
0
The percentage of subjects in clinical remission at Week 2 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
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Timepoint [5]
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0
Week 2
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Secondary outcome [6]
0
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Percentage of Subjects in Clinical Remission at Week 4
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Assessment method [6]
0
0
The percentage of subjects in clinical remission at Week 4 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
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Timepoint [6]
0
0
Week 4
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Secondary outcome [7]
0
0
Percentage of Subjects Achieving a Clinical Response at Week 2
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Assessment method [7]
0
0
The percentage of subjects achieving a clinical response at Week 2 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
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Timepoint [7]
0
0
Week 0, Week 2
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Secondary outcome [8]
0
0
Percentage of Subjects Achieving a Clinical Response at Week 4
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Assessment method [8]
0
0
The percentage of subjects achieving a clinical response at Week 4 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
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Timepoint [8]
0
0
Week 0, Week 4
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Secondary outcome [9]
0
0
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2
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Assessment method [9]
0
0
The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 2. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
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Timepoint [9]
0
0
Week 0 to Week 2
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Secondary outcome [10]
0
0
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4
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Assessment method [10]
0
0
The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 4. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
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Timepoint [10]
0
0
Week 0, Week 4
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Secondary outcome [11]
0
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Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2
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Assessment method [11]
0
0
The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 2 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
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Timepoint [11]
0
0
Week 2
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Secondary outcome [12]
0
0
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4
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Assessment method [12]
0
0
The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 4 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
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Timepoint [12]
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Week 4
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Secondary outcome [13]
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Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6
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Assessment method [13]
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The percentage of subjects in the subgroup with less than 10 mg/L of C-reactive Protein (CRP) at Entry who are in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
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Timepoint [13]
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Week 6
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Secondary outcome [14]
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Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6
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Assessment method [14]
0
0
The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
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Timepoint [14]
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0
Week 6
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Secondary outcome [15]
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Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
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Assessment method [15]
0
0
The percentage of subjects in the subgroup with less than 10 mg/L C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
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Timepoint [15]
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0
Week 0, Week 6
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Secondary outcome [16]
0
0
Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
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Assessment method [16]
0
0
The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
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Timepoint [16]
0
0
Week 0, Week 6
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Eligibility
Key inclusion criteria
* male/female
* 18 - 75 years inclusive
* diagnosis of Crohn's disease confirmed
* moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)
* no previous treatment with anti-tumor necrosis factor (anti-TNF) medications
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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
* previous participation in a certolizumab pegol study
* general exclusion criteria as common for studies in this indication
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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
1/03/2008
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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
1/11/2009
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Sample size
Target
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Accrual to date
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Final
439
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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0
- Concord
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Recruitment hospital [2]
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0
- Box Hill
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Recruitment hospital [3]
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0
- Footscray
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Recruitment hospital [4]
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0
- Parkville
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Recruitment hospital [5]
0
0
- Adelaide
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Recruitment hospital [6]
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0
- Bankstown
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Recruitment hospital [7]
0
0
- Clayton
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Recruitment hospital [8]
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0
- Fitzroy
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Recruitment hospital [9]
0
0
- Fremantle
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Recruitment hospital [10]
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- Garran
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Recruitment postcode(s) [1]
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- Concord
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Recruitment postcode(s) [2]
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0
- Box Hill
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Recruitment postcode(s) [3]
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0
- Footscray
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Recruitment postcode(s) [4]
0
0
- Parkville
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Recruitment postcode(s) [5]
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0
- Adelaide
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Recruitment postcode(s) [6]
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0
- Bankstown
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Recruitment postcode(s) [7]
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0
- Clayton
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Recruitment postcode(s) [8]
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- Fitzroy
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Recruitment postcode(s) [9]
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0
- Fremantle
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Recruitment postcode(s) [10]
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- Garran
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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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0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
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Colorado
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Country [3]
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0
United States of America
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State/province [3]
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Florida
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Country [4]
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0
United States of America
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State/province [4]
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Illinois
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Kentucky
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Louisiana
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Maryland
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Michigan
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Minnesota
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Country [10]
0
0
United States of America
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State/province [10]
0
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North Carolina
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Country [11]
0
0
United States of America
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State/province [11]
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Ohio
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Country [12]
0
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United States of America
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State/province [12]
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Pennsylvania
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Country [13]
0
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United States of America
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State/province [13]
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Tennessee
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Country [14]
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United States of America
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State/province [14]
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Virginia
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Country [15]
0
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United States of America
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State/province [15]
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Washington
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Country [16]
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Austria
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Wien
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Belgium
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Bonheiden
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Belgium
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Brussels
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Country [19]
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Belgium
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Gent
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Country [20]
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Belgium
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Leuven
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Belgium
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Liege
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Country [22]
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Belgium
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Roeselare
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Country [23]
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Brazil
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State/province [23]
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MG
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Country [24]
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Brazil
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State/province [24]
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Curitiba
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0
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Brazil
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State/province [25]
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Goiania
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Country [26]
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Brazil
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Porto Alegre
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Country [27]
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Brazil
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State/province [27]
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Rio de Janeiro
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Country [28]
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Brazil
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State/province [28]
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Santo-Andre
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Brazil
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Santos
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Brazil
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Sao Paulo
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Canada
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Alberta
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Canada
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British Columbia
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Country [33]
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Canada
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Manitoba
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Country [34]
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Canada
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Ontario
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Country [35]
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Canada
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Calgary
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Country [36]
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Chile
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Santiago
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Chile
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Vina del Mar
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Czechia
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Hradec Kralove
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Czechia
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Hradek Kralove
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Czechia
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Praha 7
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Czechia
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Usti Nad Orlici
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Czechia
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Zlin
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0
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Estonia
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Tallin
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0
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Estonia
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0
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Tartu
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0
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Finland
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Mikkeli
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0
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Freiburg
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Germany
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Homburg
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0
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Germany
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Jena
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0
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Germany
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Kiel
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0
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Germany
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Munchen
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Country [53]
0
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Germany
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Ulm
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0
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Germany
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Wilhelmshaven
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0
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Hungary
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Budapest
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Hungary
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State/province [56]
0
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Gyor
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Country [57]
0
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Hungary
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State/province [57]
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Nagykanizsa
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Country [58]
0
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Hungary
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State/province [58]
0
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Szeged
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Country [59]
0
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Hungary
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State/province [59]
0
0
Szombathely
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Country [60]
0
0
Israel
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0
0
Beer Sheva
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Country [61]
0
0
Israel
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State/province [61]
0
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Haifa
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Country [62]
0
0
Israel
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State/province [62]
0
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Holon
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Country [63]
0
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Israel
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0
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Jerusalem
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Country [64]
0
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Israel
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State/province [64]
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Kfar Saba
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0
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Israel
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State/province [65]
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0
Petha Tikva
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0
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Israel
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0
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Rehovot
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Country [67]
0
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Israel
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0
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Tel Aviv
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Country [68]
0
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Israel
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State/province [68]
0
0
Zerifin
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Country [69]
0
0
Italy
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State/province [69]
0
0
Bologna
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Country [70]
0
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Italy
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State/province [70]
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Padova
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Country [71]
0
0
Italy
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State/province [71]
0
0
Roma
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Country [72]
0
0
Latvia
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State/province [72]
0
0
Riga
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Country [73]
0
0
Latvia
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State/province [73]
0
0
Valmiera
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Country [74]
0
0
New Zealand
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State/province [74]
0
0
Auckland
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Country [75]
0
0
New Zealand
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State/province [75]
0
0
Wellington
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Country [76]
0
0
New Zealand
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State/province [76]
0
0
Christchurch
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Country [77]
0
0
New Zealand
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State/province [77]
0
0
Hamilton
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Country [78]
0
0
Poland
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State/province [78]
0
0
Czestochowa
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Country [79]
0
0
Poland
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State/province [79]
0
0
Lodz
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Country [80]
0
0
Poland
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Poland
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Cluj Napoca
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Constanta
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Kazan
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Ukraine
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Ukraine
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Simferopol
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Funding & Sponsors
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UCB Pharma
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Summary
Brief summary
The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.
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Trial website
https://clinicaltrials.gov/study/NCT00552058
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Trial related presentations / publications
Sandborn WJ, Schreiber S, Feagan BG, Rutgeerts P, Younes ZH, Bloomfield R, Coteur G, Guzman JP, D'Haens GR. Certolizumab pegol for active Crohn's disease: a placebo-controlled, randomized trial. Clin Gastroenterol Hepatol. 2011 Aug;9(8):670-678.e3. doi: 10.1016/j.cgh.2011.04.031. Epub 2011 May 13. Sandborn WJ, Melmed GY, McGovern DP, Loftus EV Jr, Choi JM, Cho JH, Abraham B, Gutierrez A, Lichtenstein G, Lee SD, Randall CW, Schwartz DA, Regueiro M, Siegel CA, Spearman M, Kosutic G, Pierre-Louis B, Coarse J, Schreiber S. Clinical and demographic characteristics predictive of treatment outcomes for certolizumab pegol in moderate to severe Crohn's disease: analyses from the 7-year PRECiSE 3 study. Aliment Pharmacol Ther. 2015 Aug;42(3):330-42. doi: 10.1111/apt.13251. Epub 2015 Jun 1. Sandborn WJ, Lee SD, Randall C, Gutierrez A, Schwartz DA, Ambarkhane S, Kayhan C, Pierre-Louis B, Schreiber S, Lichtenstein GR. Long-term safety and efficacy of certolizumab pegol in the treatment of Crohn's disease: 7-year results from the PRECiSE 3 study. Aliment Pharmacol Ther. 2014 Oct;40(8):903-16. doi: 10.1111/apt.12930. Epub 2014 Aug 22.
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Contacts
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UCB Clinical Trial Call Center
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+1 877 822 9493 (UCB)
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
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Citations or Other Details
Journal
Sandborn WJ, Schreiber S, Feagan BG, Rutgeerts P, ...
[
More Details
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Results are available at
https://clinicaltrials.gov/study/NCT00552058
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