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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00160524
Registration number
NCT00160524
Ethics application status
Date submitted
8/09/2005
Date registered
12/09/2005
Date last updated
1/08/2018
Titles & IDs
Public title
A follow-on Safety Study of CDP870 in Subjects With Crohn's Disease (CD) Who Have Completed a 26-week Double Blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]
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Scientific title
A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed 4-weekly), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Completed Studies CDP870-031 or CDP870-032
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Secondary ID [1]
0
0
2005-002622-60
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Secondary ID [2]
0
0
C87033
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Universal Trial Number (UTN)
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Trial acronym
PRECiSE 3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
0
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)
Experimental: Certolizumab Pegol - 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.
Treatment: Other: Certolizumab Pegol (CDP870)
Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study.
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Intervention code [1]
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0
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 Subjects With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months)
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Assessment method [1]
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An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
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Timepoint [1]
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Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)
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Primary outcome [2]
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Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months)
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Assessment method [2]
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An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.
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Timepoint [2]
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Up to 84 months from Study Entry (Week 0) to the Study End (Week 364) and the Safety Follow-up (Week 374)
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Secondary outcome [1]
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Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI = 4) at Study Completion Visit or (Early) Withdrawal Visit
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Assessment method [1]
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HBI remission is defined as total HBI score of 4 points or less. 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 (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.
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Timepoint [1]
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Study Completion Visit (Week 364) / (Early) Withdrawal Visit
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Secondary outcome [2]
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Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change >=3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of Feeder Study CDP870-031 or CDP870-032
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Assessment method [2]
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Response is defined as decrease in total Harvey Bradshaw Index (HBI) score of 3 or more points. 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 (8 items, score 1 per item) lower scores indicating better well-being. The first three parameters are scored for the previous day.
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Timepoint [2]
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From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of this study (up to 90 months) or (Early) Withdrawal Visit
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Secondary outcome [3]
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Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit
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Assessment method [3]
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Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
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Timepoint [3]
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Study Completion Visit (Week 364) / (Early) Withdrawal Visit
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Secondary outcome [4]
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Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-033
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Assessment method [4]
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Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in one of the previous studies CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels \> 2.4 units/mL.
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Timepoint [4]
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From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 364) of CDP870-033 (up to 90 months)
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Secondary outcome [5]
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C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit
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Assessment method [5]
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0
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Timepoint [5]
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Study Completion Visit (Week 364) / (Early) Withdrawal Visit
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Secondary outcome [6]
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Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258
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Assessment method [6]
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Timepoint [6]
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Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258
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Eligibility
Key inclusion criteria
* Participation in either of the CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] clinical studies in which the subject completed the trial at Week 26. Subjects may have received active or placebo or both treatments in the prior study
* Subjects must be able to understand the information provided to them and give written informed consent
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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
* Any exclusion criterion that would have prevented the subject's participation in the qualifying pivotal study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425], although the criterion that excludes previous participation in a clinical trial of Certolizumab Pegol does not apply. In addition there are no limits on the Clinical Disease Activity Index (CDAI) score at entry
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
1/07/2004
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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
1/08/2012
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Sample size
Target
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Accrual to date
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Final
596
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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11001 - Adelaide
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Recruitment hospital [2]
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11016 - Ballarat
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11011 - Bankstown
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11007 - Box Hill
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11013 - Frankston
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11010 - Fremantle
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11015 - Garran
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11017 - Herston
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11014 - Lauceston
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11003 - Melbourne
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11004 - Melbourne
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11005 - New Lambton
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Recruitment hospital [13]
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11018 - Newtown
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11012 - Parkville
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Ballarat
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- Bankstown
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Recruitment postcode(s) [4]
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- Box Hill
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- Frankston
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- Fremantle
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Recruitment postcode(s) [7]
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- Garran
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- Herston
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- Lauceston
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- Melbourne
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- New Lambton
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Recruitment postcode(s) [12]
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- Newtown
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Recruitment postcode(s) [13]
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- Parkville
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Recruitment outside Australia
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United States of America
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Alabama
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Colorado
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Florida
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Georgia
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United States of America
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Indiana
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Kentucky
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Maryland
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Missouri
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Palermo
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Funding & Sponsors
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UCB Pharma SA
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Summary
Brief summary
An open-label follow-on safety study of CDP870 (400 mg every 4 weeks) in patients with Crohn's Disease who have completed a 26-week blinded study (CDP870-031 \[NCT00152490\] or CDP870-032 \[NCT00152425\]).
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Trial website
https://clinicaltrials.gov/study/NCT00160524
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Trial related presentations / publications
Lichtenstein GR, Thomsen OO, Schreiber S, Lawrance IC, Hanauer SB, Bloomfield R, Sandborn WJ; Precise 3 Study Investigators. Continuous therapy with certolizumab pegol maintains remission of patients with Crohn's disease for up to 18 months. Clin Gastroenterol Hepatol. 2010 Jul;8(7):600-9. doi: 10.1016/j.cgh.2010.01.014. Epub 2010 Feb 1. Sandborn WJ, Wolf DC, Kosutic G, Parker G, Schreiber S, Lee SD, Abraham B, Afzali A, Arsenescu RI, Gutierrez A, Spearman M, Coarse J, Feagan BG. Effects of Transient and Persistent Anti-drug Antibodies to Certolizumab Pegol: Longitudinal Data from a 7-Year Study in Crohn's Disease. Inflamm Bowel Dis. 2017 Jul;23(7):1047-1056. doi: 10.1097/MIB.0000000000001100. Melmed GY, McGovern D, Schreiber S, Kosutic G, Spearman M, Coarse J, Sandborn WJ. Early remission status predicts long-term outcomes in patients with Crohn's disease treated with certolizumab pegol. Curr Med Res Opin. 2016 Dec;32(12):1937-1941. doi: 10.1080/03007995.2016.1221802. Epub 2016 Aug 22.
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Public notes
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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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What supporting documents are/will be available?
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Results publications and other study-related documents
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Results are available at
https://clinicaltrials.gov/study/NCT00160524
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