16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis
NCT01649375 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 219
Last updated 2019-10-30
Summary
This study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor
Conditions
- Anklyosing Spondylitis
Interventions
- DRUG
-
Secukinumab (75 mg)
Secukinumab 75 mg s.c.
- DRUG
-
Placebo
- DRUG
-
Secukinumab (150 mg)
Secukinumab 150 mg s.c.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-10-18
- Primary Completion
- 2014-08-04
- Completion
- 2018-09-18
- FDA Drug
- Yes
Countries
- United States
- Austria
- Canada
- Czechia
- Finland
- Germany
- Italy
- Netherlands
- Russia
- Singapore
- Spain
- Switzerland
- United Kingdom
Study Locations
More Related Trials
-
Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)
NCT03259074 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis
NCT02696031 ·Status: COMPLETED ·Phase: PHASE3
-
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis
NCT02294227 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Efficacy and Safety of Secukinumab in Japanese Patients With Active Ankylosing Spondylitis
NCT02750592 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis
NCT01752634 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Demonstrate the Efficacy, Safety and Tolerability of an Intravenous Regimen of Secukinumab Compared to Placebo in Subjects With Active axSpA
NCT04156620 ·Status: COMPLETED ·Phase: PHASE3
-
Study Estimating the Clinical Difference Between 300 mg and 150 mg of Secukinumab Following Dose Escalation to 300 mg in Patients With Ankylosing Spondylitis
NCT03350815 ·Status: COMPLETED ·Phase: PHASE4
-
Extension in AS: Sustainability of Benefits, Safety and Tolerability
NCT01863732 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission
NCT05622708 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE4
-
Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.
NCT01770379 ·Status: TERMINATED ·Phase: PHASE3
-
Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement
NCT02721966 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents (CAIN457F2309 and CAIN457F2309E1)
NCT01350804 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Examine the Clinical Efficacy and the Nonsteroidal Anti-inflammatory Drug (NSAID)-Sparing Effect of Secukinumab Over 16 Weeks in Patients With Ankylosing Spondylitis
NCT02763046 ·Status: COMPLETED ·Phase: PHASE4
-
A Study Evaluating the Efficacy of Secukinumab 300mg in Chinese Adults With Active Ankylosing Spondylitis
NCT05303285 ·Status: RECRUITING ·Phase: PHASE4
-
Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)
NCT05767034 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety Study of Secukinumab in Chinese Participants With Non-radiographic Axial Spondyloarthritis
NCT04732117 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents
NCT01377012 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Demonstrate the Efficacy and Safety of Secukinumab up to 224 Weeks in Subjects With Active Peripheral Spondyloarthritis (pSpA).
NCT05206591 ·Status: WITHDRAWN ·Phase: PHASE3
-
Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate
NCT01359943 ·Status: COMPLETED ·Phase: PHASE2
-
Real-world Study on Secukinumab Effectiveness in Biologic-naïve Ankylosing Spondylitis (AS) Patients in Korea.
NCT06905288 ·Status: RECRUITING
-
Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA)
NCT03031782 ·Status: COMPLETED ·Phase: PHASE3
-
A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis
NCT03129100 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis
NCT02757352 ·Status: COMPLETED ·Phase: PHASE3
-
An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)
NCT03769168 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Secukinumab in Patients With New Onset of Giant Cell Arteritis Who Are in Clinical Remission
NCT05380453 ·Status: COMPLETED ·Phase: PHASE3