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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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19 March 2012 |
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Main ID: |
EUCTR2006-003871-11-DE |
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Date of registration:
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26/10/2006 |
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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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An open-label, multi-center trial to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). - COSPAR II
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Scientific title:
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An open-label, multi-center trial to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I). - COSPAR II |
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Date of first enrolment:
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06/02/2007 |
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Target sample size:
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352 |
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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:2006-003871-11 |
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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: yes
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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Germany
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Patients on placebo and/or active drug who were unable to complete corticosteroid tapering or who needed to be restarted on corticosteroids, and patients suffering from Crohn's disease who have successfully completed, in remission, the C87059 trial. Patients able to understand the information provided to them and who have given written informed consent for C87065. If female, the patient is either postmenopausal for atleast one year, surgically incapable of childbearing, or effectively practicing an acceptable method of contraception( oral or parenteral hormonal contraceptive; intrauterine device; barrier or spermicide-abstinence is not an acceptable method. Patients must agree to use adequate contraception during the trial and for 12 weeks after the last dose of certolizumab. If the patient is on immunosuppresant ( azathioprine, 6-mercaptopurine and methotrexate) are allowed immunosuppresants, the dose has to have been stable during the 8 weeks preceding and throughout the C87059 trial and is expected to remain stable during the extension trial. If the patient is on a 5-ASA analogue for Crohn's disease, the dose has to have been stable during, and for the 4 weeks preceding, the C87059 trial and is expected to remain stable during the extension trial.
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:
Subjects withdrawn or discontinued from the C87059 trial for reasons other than those listed in Inclusion 1. Subject who received treatment other than trial medication and other than medications permitted in the C87059 trial. Subjects from countries where certolizumab pegol is authorised in Crohn's disease treatment. Patients who have developed medical conditions excluded in the C87059 trial will be excluded from participation in C87065. Patients who took permitted antibiotics for conditions other than Crohn's disease in C87059 will be allowed to enter trial C87065 as long as the antibiotic use has not occured within two weeks of entry into C87065.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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The trial aims to examine the long term safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol in patients with moderate to severe Crohn's disease who have failed tapering of corticosteroids, needed corticosteroids after completion of tapering, or have successfully completed the trial C87059 (COSPAR I).
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: Solution for injection
INN or Proposed INN: certolizumab pegol
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: The main objective of the trial is to continue to assess safety of certolizumab pegol as per adverse events reporting
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Secondary Objective: To describe the evolution of long term efficacy (through maintenance of clinical remission) in Crohn’s disease patients who have completed COSPAR I trial (C87059)·To assess the effect of induction/treatment with certolizumab pegol in patients who have failed to maintain clinical remission off steroids in COSPAR I trial (C87059)
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Primary end point(s): The primary efficacy variable will be the proportion of patients who completed COSPAR I and have remained off corticosteroids and in disease remission (CDAI <=150).
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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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