Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis
NCT ID: NCT02696031
Last Updated: 2022-04-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
555 participants
INTERVENTIONAL
2016-04-29
2021-03-11
Brief Summary
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Detailed Description
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* Secukinumab 150 mg Load: secukinumab 150 mg (1 mL, 150 mg/mL) s.c. pre-filled syringe (PFS) at baseline, Weeks 1, 2, and 3, followed by administration every four weeks starting at Week 4
* Secukinumab 150 mg No Load: secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS at baseline, placebo at Weeks 1, 2, and 3, followed by secukinumab 150 mg PFS administration every four weeks starting at Week 4
* Placebo: placebo (1 mL) s.c. PFS at baseline, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4.
All patients received secukinumab 150 mg as open-label treatment from Week 52 up to Week 100, unless they had discontinued study treatment.
At Week 104, all patients who finished the core phase according to the protocol were asked to continue in an optional, exploratory extension phase. Patients who achieved ASAS20 response at Week 104 (Core Phase Responders) were randomized to the following treatment groups (blinded) in the extension phase:
* Core Phase Responder 150 mg: secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS and placebo (1 mL) s.c. PFS every four weeks;
* Core Phase Responder 300 mg: 2 injections with secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS every four weeks.
Core Phase Non-Responders (not achieving ASAS20 at Week 104) were escalated to secukinumab 300 mg in an open-label manner.
\- Core Phase Non-Responder 300 mg: 2 injections with secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS every four weeks open-label.
Starting from Week 156 onward, a patient could switch to secukinumab 300 mg open-label based on the clinical judgment of disease activity by the investigator.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Group 1 (secukinumab 150 mg Load): secukinumab 150 mg (1 mL, 150 mg/mL) s.c. prefilled syringe (PFS) at baseline (BSL), Weeks 1, 2 and 3, followed by administration every four weeks starting at Week 4
* Group 2 (secukinumab 150 mg No Load): secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS at BSL, placebo at Weeks 1, 2 and 3, followed by secukinumab 150 mg PFS administration every four weeks starting at Week 4
* Group 3 (placebo): placebo (1 mL) s.c. PFS at BSL, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4 Based on the clinical judgment of disease activity by the investigator and the patient, background medications, such as NSAIDs and DMARDs, may have been modified or added to treat signs and symptoms of nr-axSpA from Week 16 on.
TREATMENT
QUADRUPLE
Study Groups
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Secukinumab, 150 mg Load (Core phase)
Secukinumab 150 mg s.c., pre-filled syringe (PFS) at baseline, Weeks 1, 2, and 3, followed by administration every four weeks starting at Week 4, Load, Core phase
Secukinumab
Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly
Secukinumab, 150 mg No Load (Core phase)
Secukinumab 150 mg s.c. PFS at baseline, placebo at Weeks 1, 2, and 3, followed by secukinumab 150 mg PFS administration every four weeks starting at Week 4, No Load, Core phase
Secukinumab
Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly
Placebo (Core phase)
Placebo s.c., PFS at baseline, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4, Core phase
Placebo
Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly
Core Phase Responder 150 mg (Extension phase)
Core Phase Responder 150 mg blinded: secukinumab 150 mg s.c. PFS and placebo (1 mL) s.c. PFS every four weeks, in the Extension phase
Secukinumab
Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly
Placebo
Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly
Core Phase Responder 300 mg (Extension phase)
Core Phase Responder 300 mg blinded: 2 injections with secukinumab 150 mg s.c. PFS every four weeks, in the Extension phase
Secukinumab
Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly
Core Phase Non-Responder 300 mg (Extension phase)
Core Phase Non-Responder 300 mg: 2 injections with secukinumab 150 mg s.c. PFS every four weeks open-label, in the Extension phase
Secukinumab
Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly
Interventions
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Secukinumab
Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly
Placebo
Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of axial spondyloarthritis according to Ankylosing SpondyloArthritis International Society (ASAS) axial spondyloarthritis criteria
* objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
* active axial spondyloarthritis as assessed by total Bath Ankylosing Spondylitis Disease Activity Index \>=4 cm
* Spinal pain as measured by Bath Ankylosing Spondylitis Disease Activity Index question #2 ≥ 4 cm (0-10 cm) at baseline
* Total back pain as measured by Visual Analogue scale ≥ 40 mm (0-100 mm) at baseline
* Patients should have been on at least 2 different non-steroidal anti-inflammatory drugs with an inadequate response
* Patients who have been on a Tumor Necrosis Factor (TNF) α inhibitor (not more than one) must have experienced an inadequate response
Exclusion Criteria
* Inability or unwillingness to undergo MRI
* Chest X-ray or MRI with evidence of ongoing infectious or malignant process
* Patients taking high potency opioid analgesics
* Previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor
* Pregnant or nursing (lactating) women
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Birmingham, Alabama, United States
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Beverly Hills, California, United States
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Fullerton, California, United States
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Denver, Colorado, United States
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Gainesville, Florida, United States
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Idaho Falls, Idaho, United States
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Bowling Green, Kentucky, United States
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Lansing, Michigan, United States
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Great Falls, Montana, United States
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Albany, New York, United States
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Potsdam, New York, United States
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Charlotte, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Duncansville, Pennsylvania, United States
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Charleston, South Carolina, United States
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Leander, Texas, United States
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Mesquite, Texas, United States
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Coffs Harbour, New South Wales, Australia
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Maroochydore, Queensland, Australia
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Hobart, Tasmania, Australia
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Malvern East, Victoria, Australia
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Woolloongabba, , Australia
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Graz, , Austria
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Vienna, , Austria
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Brussels, , Belgium
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Genk, , Belgium
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Ghent, , Belgium
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Prague, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Brno-Zidonice, CZE, Czechia
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Brno, CZ, Czechia
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Uherské Hradiště, , Czechia
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Limoges, Haute Vienne, France
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Bordeaux, , France
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Boulogne-Billancourt, , France
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Chambray-lès-Tours, , France
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Monaco, , France
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Paris, , France
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Poitiers, , France
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Rouen, , France
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Hanover, Lower Saxony, Germany
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Berlin, , Germany
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Berlin, , Germany
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Cottbus, , Germany
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Dresden, , Germany
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Erlangen, , Germany
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Freiburg im Breisgau, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Herne, , Germany
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Magdeburg, , Germany
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Potsdam, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Eger, , Hungary
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Szeged, , Hungary
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Székesfehérvár, , Hungary
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Veszprém, , Hungary
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Haifa, , Israel
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Kfar Saba, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Verona, VR, Italy
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Bologna, , Italy
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Novara, , Italy
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Padua, , Italy
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Pisa, , Italy
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Kita-gun, Kagawa-ken, Japan
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Kawachi-Nagano, Osaka, Japan
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Bunkyo Ku, Tokyo, Japan
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Chuo Ku, Tokyo, Japan
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Meguro City, Tokyo, Japan
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Shinjuku Ku, Tokyo, Japan
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Torreón, Coahuila, Mexico
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Guadalajara, Jalisco, Mexico
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Culiacan, State of Mexico, Mexico
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Metepec, State of Mexico, Mexico
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Amsterdam, , Netherlands
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Groningen, , Netherlands
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Maastricht, , Netherlands
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Kongsvinger, , Norway
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Moss, , Norway
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Krakow, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Almada, , Portugal
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Braga, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Ponte de Lima, , Portugal
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Barnaul, , Russia
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Kemerovo, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Smolensk, , Russia
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Yekaterinburg, , Russia
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Seoul, , South Korea
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Seoul, , South Korea
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Elda, Alicante, Spain
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Córdoba, Andalusia, Spain
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Málaga, Andalusia, Spain
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Seville, Andalusia, Spain
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L'Hospitalet de Llobregat, Barcelona, Spain
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Sabadell, Barcelona, Spain
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Bilbao, Basque Country, Spain
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Santander, Cantabria, Spain
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A Coruña, Galicia, Spain
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Santiago de Compostela, Galicia, Spain
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Vigo, Pontevedra, Spain
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Valencia, Valencia, Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Gothenburg, , Sweden
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Lund, , Sweden
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Uppsala, , Sweden
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Basel, , Switzerland
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Fribourg, , Switzerland
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Ankara, , Turkey (Türkiye)
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Westcliff-on-Sea, Essex, United Kingdom
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Leytonstone, London, United Kingdom
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Stoke-on-Trent, Staffordshire, United Kingdom
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Worthing, West Sussex, United Kingdom
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Bath, , United Kingdom
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Doncaster, , United Kingdom
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Middlesbrough, , United Kingdom
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Northampton, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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References
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Jamaludin A, Windsor R, Ather S, Kadir T, Zisserman A, Braun J, Gensler LS, Ostergaard M, Poddubnyy D, Coroller T, Porter B, Ligozio G, Readie A, Machado PM. Automated detection of spinal bone marrow oedema in axial spondyloarthritis: training and validation using two large phase 3 trial datasets. Rheumatology (Oxford). 2025 Jun 9:keaf323. doi: 10.1093/rheumatology/keaf323. Online ahead of print.
Braun J, Blanco R, Marzo-Ortega H, Gensler LS, Van den Bosch F, Hall S, Kameda H, Poddubnyy D, van de Sande M, van der Heijde D, Zhuang T, Stefanska A, Readie A, Richards HB, Deodhar A. Two-year imaging outcomes from a phase 3 randomized trial of secukinumab in patients with non-radiographic axial spondyloarthritis. Arthritis Res Ther. 2023 May 16;25(1):80. doi: 10.1186/s13075-023-03051-5.
Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.
Braun J, Blanco R, Marzo-Ortega H, Gensler LS, van den Bosch F, Hall S, Kameda H, Poddubnyy D, van de Sande M, Wiksten AS, Porter BO, Shete A, Richards HB, Haemmerle S, Deodhar A. Secukinumab in non-radiographic axial spondyloarthritis: subgroup analysis based on key baseline characteristics from a randomized phase III study, PREVENT. Arthritis Res Ther. 2021 Sep 4;23(1):231. doi: 10.1186/s13075-021-02613-9.
Deodhar A, Blanco R, Dokoupilova E, Hall S, Kameda H, Kivitz AJ, Poddubnyy D, van de Sande M, Wiksten AS, Porter BO, Richards HB, Haemmerle S, Braun J. Improvement of Signs and Symptoms of Nonradiographic Axial Spondyloarthritis in Patients Treated With Secukinumab: Primary Results of a Randomized, Placebo-Controlled Phase III Study. Arthritis Rheumatol. 2021 Jan;73(1):110-120. doi: 10.1002/art.41477. Epub 2020 Nov 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CAIN457H2315
Identifier Type: -
Identifier Source: org_study_id
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