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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-BE |
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Date of registration:
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01/09/2006 |
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Prospective Registration:
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Yes |
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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.
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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. |
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Date of first enrolment:
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18/10/2006 |
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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: yes
Randomised:
Open: yes
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
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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Key inclusion & exclusion criteria
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Inclusion criteria:
Crohn’s disease diagnosis·
Patients (previously treated with infliximab) having completed the maintenance phase of study C87042 and being in response ·
Patient remaining able to understand the information provided to them and to give written informed consent for C87046·
Female patient either postmenopausal for at least one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception (oral or parenteral hormonal contraceptives; intrauterine device; 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 CDP870.
Concomitant medicationsSame concomitant medications as in C87042 study will be allowed (5-ASA, azathioprine and 6- mercaptopurine or methotrexate).
Are the trial subjects under 18?
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:
Subject must not be included if they meet any of the following criteria· Subject withdrawn prematurely from C87042 study·
Subject who received treatment other than certolizumab pegol and other than medications permitted in C87042 study·
Subjects from countries where certolizumab pegol is authorized in Crohn’s disease treatment.
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 with Crohn's disease and having completed C87042 study.
MedDRA version: 8.1
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
INN or Proposed INN: certolizumab pegol
Current Sponsor code: CDP870
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: range
Concentration number: 150+/-15-
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Primary Outcome(s)
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Main Objective: To continue to assess safety of certolizumab pegol as per adverse event reporting.
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Primary end point(s): Efficacy Variables
Proportion of patients in clinical response at week 0 with maintenance of clinical response*, as assessed by CDAI score every 4 weeks.*Loss of response is defined as both a CDAI score >150 points and a minimum increase in CDAI of 70 points versus week 0 (week 26 of C87042 study) as confirmed at two consecutive visits.CDAI score and its change from Week 0, as measured every 4 weeks.Remission rate with remission defined as CDAI score = 150 every 4 weeks.
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Secondary Objective: To describe the evolution of 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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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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