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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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7 October 2014 |
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Main ID: |
EUCTR2008-005320-81-BE |
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Date of registration:
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20/02/2009 |
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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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A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2
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Scientific title:
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A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2 |
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Date of first enrolment:
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16/02/2009 |
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Target sample size:
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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:2008-005320-81 |
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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: no
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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Germany
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Spain
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Patients who completed the extension 1 study may enter the extension 2 study upon
signing informed consent.
A patient is defined as completing the extension 1 study if he/she completed the study up to and including Visit 31.
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:
Patients for whom continuation of treatment in the extension 2 is not considered
appropriate by the treating physician.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation confirmed by a positive
hCG laboratory test (>5mIU/mL).
Women of childbearing potential (WOCBP) defined as all women physiologically capable of becoming pregnant, UNLESS they are: • Using a double barrier method of contraception such as intrauterine devices (IUDs), oral contraceptives, sub-dermal implants and a barrier method with spermicide, condoms. • Women whose partners have been sterilized by vasectomy or other means. • Considered post-menopausal and not of childbearing potential if they have had 24 months of natural (spontaneous) amenorrhea or six months of spontaneous amenorrhea with serum
FSH levels > 40 mIU/mL (for US only estradiol < 20 pg/mL) or have had surgical
bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
Note: FSH and estradiol tests do not need to be performed for surgically sterile or women on estrogen replacement therapy. Females of childbearing potential must agree to continue to practice an acceptable form of birth control during the trial and for at least 2 months after completing the trial.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
MedDRA version: 9.1
Level: LLT
Classification code 10039073
Term: Rheumatoid arthritis
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Intervention(s)
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Product Name: ACZ885
Product Code: ACZ885
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Canakinumab
Current Sponsor code: ACZ885
Other descriptive name: Recombinant human monoclonal antibody to inerleukin-1beta of the IgG1-K-class
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
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Primary Outcome(s)
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Main Objective: To assess long-term safety and tolerability of canakinumab (ACZ885) in patients with
active RA who completed the first extension study.
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Secondary Objective: To evaluate the efficacy of canakinumab (ACZ885) by assessing the response to treatment according to ACR20, ACR50 and ACR70 criteria and DAS28.
To assess the effect of canakinumab on ACR components, including a marker of
inflammation (hsCRP).
To assess pharmacokinetic profile of canakinumab.
To assess immunogenicity of canakinumab.
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Primary end point(s):
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Secondary ID(s)
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CACZ885A2201E2
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2008-005320-81-AT
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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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