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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
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.
Secondary ID [1] 0 0
2007-001913-41
Secondary ID [2] 0 0
C87085
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn 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
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
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Subjects in Clinical Remission at Week 6
Timepoint [1] 0 0
Week 6
Secondary outcome [1] 0 0
Percentage of Subjects Achieving a Clinical Response at Week 6
Timepoint [1] 0 0
Week 0, Week 6
Secondary outcome [2] 0 0
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6
Timepoint [2] 0 0
Week 6
Secondary outcome [3] 0 0
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6
Timepoint [3] 0 0
Week 0 to Week 6
Secondary outcome [4] 0 0
Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6
Timepoint [4] 0 0
Week 0 to Week 6
Secondary outcome [5] 0 0
Percentage of Subjects in Clinical Remission at Week 2
Timepoint [5] 0 0
Week 2
Secondary outcome [6] 0 0
Percentage of Subjects in Clinical Remission at Week 4
Timepoint [6] 0 0
Week 4
Secondary outcome [7] 0 0
Percentage of Subjects Achieving a Clinical Response at Week 2
Timepoint [7] 0 0
Week 0, Week 2
Secondary outcome [8] 0 0
Percentage of Subjects Achieving a Clinical Response at Week 4
Timepoint [8] 0 0
Week 0, Week 4
Secondary outcome [9] 0 0
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2
Timepoint [9] 0 0
Week 0 to Week 2
Secondary outcome [10] 0 0
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4
Timepoint [10] 0 0
Week 0, Week 4
Secondary outcome [11] 0 0
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2
Timepoint [11] 0 0
Week 2
Secondary outcome [12] 0 0
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4
Timepoint [12] 0 0
Week 4
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Week 6
Secondary outcome [14] 0 0
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
Timepoint [14] 0 0
Week 6
Secondary outcome [15] 0 0
Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
Timepoint [15] 0 0
Week 0, Week 6
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
Timepoint [16] 0 0
Week 0, Week 6

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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* previous participation in a certolizumab pegol study
* general exclusion criteria as common for studies in this indication

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
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
Intervention assignment
Parallel
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
1/03/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2009
Sample size
Target
Accrual to date
Final
439
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Concord
Recruitment hospital [2] 0 0
- Box Hill
Recruitment hospital [3] 0 0
- Footscray
Recruitment hospital [4] 0 0
- Parkville
Recruitment hospital [5] 0 0
- Adelaide
Recruitment hospital [6] 0 0
- Bankstown
Recruitment hospital [7] 0 0
- Clayton
Recruitment hospital [8] 0 0
- Fitzroy
Recruitment hospital [9] 0 0
- Fremantle
Recruitment hospital [10] 0 0
- Garran
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
- Footscray
Recruitment postcode(s) [4] 0 0
- Parkville
Recruitment postcode(s) [5] 0 0
- Adelaide
Recruitment postcode(s) [6] 0 0
- Bankstown
Recruitment postcode(s) [7] 0 0
- Clayton
Recruitment postcode(s) [8] 0 0
- Fitzroy
Recruitment postcode(s) [9] 0 0
- Fremantle
Recruitment postcode(s) [10] 0 0
- Garran
Recruitment outside Australia
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Alabama
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Tennessee
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Virginia
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Washington
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Austria
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Wien
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Belgium
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Bonheiden
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Brussels
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Leuven
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Roeselare
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MG
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Rehovot
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Zerifin
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Italy
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Bologna
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Lviv
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Simferopol

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
UCB Pharma
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00552058
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.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00552058