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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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18 April 2012 |
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Main ID: |
EUCTR2006-001729-24-IT |
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Date of registration:
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26/06/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study - C87046
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Scientific title:
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Open label long term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy with certolizumab pegol, a PEGylated Fab fragment of humanized antibody to tumor necrosis factor alpha (TNF) in patients suffering from Crohn's disease and having completed C87042 study - C87046 |
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Date of first enrolment:
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10/05/2007 |
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Target sample size:
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600 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-001729-24 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Confirmatorio, a lungo termine
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Austria
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Belgium
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France
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Germany
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Italy
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Netherlands
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Spain
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Sweden
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
-Crohn's disease diagnosis
-Patients (previously treated with infliximab) having completed study C87042
-Patients remaining able to understand the information provided to them and to give written informed consent for C87046 study.
-Female patients either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral o parenteral hormonal contraceptives; intruterine devices; barrier and spermicide. Abstinence is not an acceptable method). Patients must agree to continue to use adequate contraception during the study and for 12 weeks after the last dose of certolizumab pegol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
-Subjects withdrawn prematurely from C87042 study
-Subjects who received treatment other than certolizumab pegol and other than medications permitted in C87042 study (For Crohn's disease treatmen)
-Subjects from countries where extensions of clinical trial are not allowed, however these patients will have the opportunity to be entered in a compassionate use program.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Patients suffering from Crohn's disease and having completed the C87042 study
MedDRA version: 9.1
Level: LLT
Classification code 10011401
Term: Crohn's disease
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Intervention(s)
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Product Name: certolizumab pegol
Product Code: CDP870
Pharmaceutical Form: Powder for solution for injection
CAS Number: 428863-50-7
Current Sponsor code: CDP870
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
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Primary Outcome(s)
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Primary end point(s): -Proportion of patients in clinical response at week 0 with maintenance of clinical response, as assessed by CDAI score at V1, V2 and from then on every 4 weeks
-CDAI score and its change from Week 0, as measured at V1, V2 and from then on every 4 weeks
-Incidence of adverse events reported by the patients during the long-term treatment period of the study
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Main Objective: -To continue to assess safety of certolizumab pegol as per adverse event reporting.
-To describe the evolution og long term efficacy (through maintenance of clinical response) in Crohn's disease patients who completed C87042 study.
-To assess the effect of subcutaneous certolizumab pegol 400 mg on direct cost parameters.
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Secondary Objective:
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Secondary ID(s)
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RPCE06C1511
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2006-001729-24-BE
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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