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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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26 June 2012 |
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Main ID: |
EUCTR2010-019263-11-AT |
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Date of registration:
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13/04/2010 |
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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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A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN
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Scientific title:
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A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN |
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Date of first enrolment:
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19/05/2010 |
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Target sample size:
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270 |
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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:2010-019263-11 |
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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: no
Randomised:
Open:
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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Czech Republic
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France
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Hungary
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Lithuania
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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:
I 01. Patients with AS that have completed 12 weeks of treatment in the DRI11073 study.
I 02. Patients must give informed consent for participating in the LTS11298 study prior to any procedure related to the study.
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:
E 01. Any patients who experienced any adverse events leading to treatment discontinuation from the DRI11073 study.
E 02. Any abnormalities or adverse events at the last treatment visit of the DRI11073 study that per Investigator judgment would adversely affect patient’s participation in this study.
E 03. Positive pregnancy test at the last visit in the DRI 11073 study.
E 04. Breast-feeding women.
E 05. For women of childbearing potential, unwillingness to utilize adequate contraception methods or not become pregnant during the full course of the study. Adequate contraceptive measures include oral contraceptives (stable use for 2 or more cycles prior to screening) and other prescription pharmaceutical contraceptives; IUD; bilateral tubal legations; vasectomy; condom or diaphragm plus either contraceptive sponge, foam or jelly. If subject is on MTX and/ or any other concomitant medication, please follow their precautions and recommendations. For example, if a subject is on Methotrexate, which requires a longer term use of contraception, then the longer period should be used to protect safety of subject.
E 06. Men who are unwilling to utilize 2 form of contraception: a condom and a spermicidal agent.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
MedDRA version: 12.1
Level: LLT
Classification code 10002556
Term: Ankylosing spondylitis
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Intervention(s)
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Product Code: SAR153191
Pharmaceutical Form: Solution for injection
Current Sponsor code: SAR153191
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 75-
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Primary Outcome(s)
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Main Objective: The primary objective of the study is to evaluate the long term safety of SAR153191 in patients with AS
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Primary end point(s): The percentage of patients who experienced a TEAE during the study
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Secondary Objective: The secondary objectives are all related to the long term efficacy of SAR153191 as assessed by the following:
• ASAS 20
• ASAS partial remission
• disease activity (BASDAI)
• range of motion assessed by Bath AS Metrology Index (BASMI) (10-point scale)
• Ankylosing Spondylitis Disease Activity Score (ASDAS)
• Magnetic Resonance Imaging (MRI) of the spine
• X-Ray of the spine; cervical and lumbar spine lateral view
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Secondary ID(s)
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2010-019263-11-BE
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LTS11298
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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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