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Main
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Note: This record shows only the 20 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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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01109940 |
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Date of registration:
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22/04/2010 |
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Primary sponsor: |
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Public title:
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Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis
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Scientific title:
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An Open Label Non-randomized Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti Interleukin-17 Monoclonal Antibody) in Patients With Moderate to Severe Ankylosing Spondylitis |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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39 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01109940 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Netherlands
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United Kingdom
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United States
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Contacts
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Name:
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Novartis Pharmaceuticals |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novartis Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- A diagnosis of ankylosing spondylitis
- Patients who took part in the core CAIN457A2209 study
Exclusion Criteria:
- Patients for whom continued treatment with AIN457 is not considered appropriate by
the treating physician.
- Patients who were non-compliant or who demonstrated a major protocol deviation in the
core CAIN457A2209 study.
- Patients who discontinued from the core CAIN457A2209 study before Visit 14 (Week 16),
and patients who completed the core study or discontinued the core study more than 2
weeks before the baseline visit.
- Pregnant or lactating women
- Presence of active infection
- Positive PPD or HIV test in patients where repeated testing was deemed appropriate
due to their risk profile
Other protocol-defined inclusion/exclusion criteria may apply
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Intervention(s)
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Biological: AIN457A
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Primary Outcome(s)
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Safety and tolerability (Vital signs, ECG, Hematology; Blood chemistry; Urinalysis, Adverse Events, Immunogenicity)
[Time Frame: Up to 64 weeks]
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Secondary Outcome(s)
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Immunogenicity of AIN457
[Time Frame: Up to 64 weeks]
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Pharmacokinetics of AIN457 at steady state
[Time Frame: Up to 64 weeks]
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Total IL-17 concentration in blood at steady-state
[Time Frame: Up to 64 weeks]
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Secondary ID(s)
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2009-011591-30
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CAIN457A2209E1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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