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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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
Colorado
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United States of America
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Florida
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United States of America
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Illinois
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Kentucky
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Louisiana
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Maryland
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Michigan
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Minnesota
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North Carolina
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Ohio
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Pennsylvania
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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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Belgium
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Brussels
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Gent
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Leuven
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Belgium
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Liege
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Belgium
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Roeselare
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Brazil
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MG
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Curitiba
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Santos
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Hradec Kralove
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Hradek Kralove
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Praha 7
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Zlin
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Tallin
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Tartu
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Jena
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Ulm
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Gyor
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Holon
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Kfar Saba
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Rehovot
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Tel Aviv
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Zerifin
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Italy
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Bologna
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Italy
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Padova
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Roma
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Wellington
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Christchurch
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Hamilton
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Poland
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Czestochowa
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Lodz
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Romania
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Bucharest
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Cluj Napoca
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Constanta
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Kiev
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Kyiv
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Lviv
Country [93] 0 0
Ukraine
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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
Trial website
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
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

TypeCitations or Other Details
Journal Sandborn WJ, Schreiber S, Feagan BG, Rutgeerts P, ... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00552058