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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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]
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
Secondary ID [1] 0 0
2005-002622-60
Secondary ID [2] 0 0
C87033
Universal Trial Number (UTN)
Trial acronym
PRECiSE 3
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 - 400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.


Other interventions: 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.

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 the Study CDP870-033 (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 364) and the Safety Follow-up (Week 374)
Primary outcome [2] 0 0
Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (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 364) and the Safety Follow-up (Week 374)
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 364) / (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 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
Secondary outcome [3] 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 [3] 0 0
Study Completion Visit (Week 364) / (Early) Withdrawal Visit
Secondary outcome [4] 0 0
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 - 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 [4] 0 0
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)
Secondary outcome [5] 0 0
C-Reactive Protein (CRP) Level at Study Completion Visit or (Early) Withdrawal Visit
Timepoint [5] 0 0
Study Completion Visit (Week 364) / (Early) Withdrawal Visit
Secondary outcome [6] 0 0
Faecal Calprotectin Level at Week 258 Visit or (Early) Withdrawal Visit, if it is Earlier Than Week 258
Timepoint [6] 0 0
Week 258 / (Early) Withdrawal Visit, if it is earlier than Week 258

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
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 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

Study design
Purpose of the study
Treatment
Allocation to intervention
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)
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11001 - Adelaide
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11016 - Ballarat
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- New Lambton
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- Newtown
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- Parkville
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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
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]).
Trial website
https://clinicaltrials.gov/show/NCT00160524
Trial related presentations / publications
Lichtenstein GR, Thomsen OØ, 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.
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
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications