This 3-year extension study aims at making available the treatment with secukinumab in prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III study CAIN457F2305, defined as "core study", as well as to generate additional data on the sustainability of clinical benefits, safety and tolerability during long-term administration of secukinumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
274
Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W
Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group.
Time frame: Week 104 to Week 260
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260
ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 40 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was performed This was the total for Group 1 Participants that up-titrated are counted only at the originally randomized treatment group
Time frame: Week 104 to Week 260
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Duncansville, Pennsylvania, United States
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Jackson, Tennessee, United States
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Kingsport, Tennessee, United States
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Spokane, Washington, United States
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Brussels, Belgium
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Genk, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Burgas, Bulgaria
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