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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00160706




Registration number
NCT00160706
Ethics application status
Date submitted
8/09/2005
Date registered
12/09/2005
Date last updated
7/08/2018

Titles & IDs
Public title
A follow-on Safety Study in Subjects With Crohn's Disease Who Have Previously Been Withdrawn From the Double-blind Study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] Due to an Exacerbation of Crohn's Disease
Scientific title
A Phase III Multi-national, Multi-centre, Open Label, Safety Study to Assess the Safety of Re-exposure After a Variable Interval and Subsequent Chronic Therapy With the Humanised Anti-TNF PEG Conjugate CDP870 400 mg sc, (Dosed at Weeks 0, 2 and 4 Then Every 4 Weeks), in the Treatment of Patients With Active Crohn's Disease Who Have Previously Been Withdrawn From Studies CDP870-031 or CDP870-032 Due to an Exacerbation of Crohn's Disease.
Secondary ID [1] 0 0
2005-002623-13
Secondary ID [2] 0 0
C87034
Universal Trial Number (UTN)
Trial acronym
PRECiSE 4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Other interventions - Certolizumab Pegol (CDP870)

Experimental: Certolizumab Pegol - 3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.


Other interventions: Certolizumab Pegol (CDP870)
Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.
Up to 84 months of therapy in this study.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of This Study CDP870-034 (up to 84 Months) - 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.
Timepoint [1] 0 0
Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)
Primary outcome [2] 0 0
Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-034 (up to 84 Months) - 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.
Timepoint [2] 0 0
Up to 84 months from Study Entry (Week 0) to the Study End (Week 362 ) and the Safety Follow-up (Week 372)
Secondary outcome [1] 0 0
Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI = 4) at Study Completion Visit or (Early) Withdrawal Visit - 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.
Timepoint [1] 0 0
Study Completion Visit (Week 362) / (Early) Withdrawal Visit
Secondary outcome [2] 0 0
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 - 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.
Timepoint [2] 0 0
From Baseline of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] to Study Completion Visit (Week 362) or (Early) Withdrawal Visit of this study (up to 90 months)
Secondary outcome [3] 0 0
Percentage of Subjects in Harvey Bradshaw Index (HBI) Response (HBI Change = 3) at Study Completion Visit or (Early) Withdrawal Visit From Week 0 of CDP870-034 - 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.
Timepoint [3] 0 0
From Week 0 of study CDP870-034 to Study Completion Visit (Week 362) or (Early) Withdrawal Visit (up to 84 months)
Secondary outcome [4] 0 0
Plasma Concentration of Certolizumab Pegol at Study Completion Visit or (Early) Withdrawal Visit - Plasma Samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.
Timepoint [4] 0 0
Study Completion Visit (Week 362) / (Early) Withdrawal Visit
Secondary outcome [5] 0 0
Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Studies CDP870-031 or CDP870-032 to the Study Completion Visit in CDP870-034 - 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.
Timepoint [5] 0 0
From Week 0 of study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] up to Study Completion Visit (Week 362) of CDP870-034 (up to 90 months)
Secondary outcome [6] 0 0
C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit
Timepoint [6] 0 0
Study Completion Visit (Week 362) / (Early) Withdrawal Visit
Secondary outcome [7] 0 0
Fecal Calprotectin Level at Week 256 or (Early) Withdrawal Visit, if it is Earlier Than Week 256
Timepoint [7] 0 0
Week 256 / (Early) Withdrawal Visit, if it is earlier than Week 256

Eligibility
Key inclusion criteria
- Participation in either of the CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425]
clinical studies in which the subject completed the Week 2 assessment in CDP870-031
[NCT00152490] or the Week 6 randomization in CDP870-032 [NCT00152425] but whose
Crohn's Disease was significantly worse as determined by the investigator and whose
Clinical Disease Activity Index (CDAI) score at entry to this study is either
(subjects may have received active or placebo treatment):

1. At least 70 points higher then Baseline (Week 0 CDP870-031 [NCT00152490]; Week 6
CDP870 032 [NCT00152425] responders) OR

2. Higher than Baseline (Week 0 CDP870-031 [NCT00152490]; Week 6 CDP870-032
[NCT00152425] responders) with an absolute score of at least 350 points

- Subjects must be able to understand the information provided to them and give written
informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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 upper limit of 450 in the CDAI score is not applicable. In addition the
criterion that excludes previous participation in a clinical trial of Certolizumab
Pegol does not apply

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
11011 - Bankstown
Recruitment hospital [2] 0 0
11005 - New Lambton
Recruitment hospital [3] 0 0
11017 - Herston
Recruitment hospital [4] 0 0
11006 - South Brisbane
Recruitment hospital [5] 0 0
11014 - Lauceston
Recruitment hospital [6] 0 0
11016 - Ballarat
Recruitment hospital [7] 0 0
11007 - Box Hill
Recruitment hospital [8] 0 0
11002 - Fitzroy
Recruitment hospital [9] 0 0
11013 - Frankston
Recruitment hospital [10] 0 0
11012 - Parkville
Recruitment hospital [11] 0 0
11009 - Adelaide
Recruitment hospital [12] 0 0
11010 - Fremantle
Recruitment hospital [13] 0 0
11015 - Garran
Recruitment hospital [14] 0 0
11018 - Newtown
Recruitment postcode(s) [1] 0 0
- Bankstown
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- New Lambton
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- Herston
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- South Brisbane
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- Lauceston
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- Ballarat
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- Box Hill
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- Fitzroy
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- Frankston
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- Parkville
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- Adelaide
Recruitment postcode(s) [12] 0 0
- Fremantle
Recruitment postcode(s) [13] 0 0
- Garran
Recruitment postcode(s) [14] 0 0
- Newtown
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
UCB Pharma SA
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A follow-on safety study in subjects with Crohn's Disease who have previously been withdrawn
from the double-blind study CDP870-031 [NCT00152490] or CDP870-032 [NCT00152425] due to an
exacerbation of Crohn's Disease.
Trial website
https://clinicaltrials.gov/show/NCT00160706
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
UCB Clinical Trial Call Center
Address 0 0
+1 877 822 9493 (UCB)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications