Extension in AS: Sustainability of Benefits, Safety and Tolerability

Phase 3

Completed

Conditions: Spondylitis, Ankylosing

Registration Number: NCT01863732

Lead Sponsor: Novartis Pharmaceuticals

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 274

Inclusion Criteria

patients having completed the "core study" CAIN457F2305, indication for treatment extension. --

Exclusion Criteria

history of hypersensitivity to secukinumab or to any drug of similar chemical classes, use of any investigational drug other than secukinumab during the "core study" CAIN457F2305.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of Spondyloarthritis International Society Criteria (ASAS) 20 Response From Week 104 to Week 260	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.

Secondary Outcome Measures

Name	Time	Method
Assessment of Spondyloarthritis International Society Criteria (ASAS) 40 Response From Week 104 to Week 260	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