Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)
NCT ID: NCT03259074
Last Updated: 2023-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
859 participants
INTERVENTIONAL
2017-11-30
2021-11-29
Brief Summary
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Detailed Description
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Subjects in both secukinumab dose groups received study treatment at baseline, Weeks 1, 2, 3 and 4 followed by treatment every 4 weeks through Week 100. Subjects in the GP2017 group received study treatment at baseline and every two weeks through Week 102. Subjects could self-administer all secukinumab / placebo and GP2017 doses at the study site or at home. Study treatment (secukinumab vs. GP2017) was provided in an open-label fashion. Subjects in the secukinumab groups were blinded to the dose (150 mg vs. 300 mg). Subjects who received rescue treatment with prohibited medications were allowed to remain in the study but had to discontinue study treatment. Subjects were treated for 104 weeks with two follow-up visits (Weeks 112 and 120).
A total of 859 subjects were randomized to treatment at 171 sites in 30 countries in Europe, North America, South America, and Asia.
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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AIN457 150 mg/placebo
AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100
Placebo
Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes
AIN457 150 mg
150 mg in pre-filled syringes was administered subcutaneously
AIN457 300 mg
AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100
AIN457 150 mg
150 mg in pre-filled syringes was administered subcutaneously
GP2017 40mg
GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 102
GP2017 (adalimumab biosimilar)
40 mg in pre-filled syringes was administered subcutaneously
Interventions
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Placebo
Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes
GP2017 (adalimumab biosimilar)
40 mg in pre-filled syringes was administered subcutaneously
AIN457 150 mg
150 mg in pre-filled syringes was administered subcutaneously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence (centrally read X-ray) fulfilling the Modified New York criteria for AS despite previous or current NSAID/ nonbiologic DMARD therapy
* Active AS assessed by total BASDAI ≥ 4 on a scale of 0-10
* Spinal pain as measured by BASDAI question #2 ≥ 4 (0-10)
* Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm)
* hsCRP ≥ 5 mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray
Exclusion Criteria
* Pregnant or nursing (lactating) women
* Evidence of ongoing infectious or malignant process
* Previous exposure to any biologic immunomodulating agent, including those targeting IL-17, IL-17 receptor or TNFα
* Subjects taking high potency opioid analgesics
* Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents
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
Mesa, Arizona, United States
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Escondido, California, United States
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La Mesa, California, United States
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San Francisco, California, United States
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Gainesville, Florida, United States
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Boise, Idaho, United States
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Shreveport, Louisiana, United States
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Wheaton, Maryland, United States
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Great Falls, Montana, United States
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Lincoln, Nebraska, United States
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Greensboro, North Carolina, United States
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Dayton, Ohio, United States
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Middleburg Heights, Ohio, United States
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Portland, Oregon, United States
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Duncansville, Pennsylvania, United States
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Memphis, Tennessee, United States
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Mesquite, Texas, United States
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Kennewick, Washington, United States
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Franklin, Wisconsin, United States
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Ciudad Autonoma de Bs As, , Argentina
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Malvern East, Victoria, Australia
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Brussels, , Belgium
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Genk, , Belgium
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Winnipeg, Manitoba, Canada
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Barrie, Ontario, Canada
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Québec, Quebec, Canada
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Trois-Rivières, Quebec, Canada
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Santiago, RM, Chile
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Concepción, , Chile
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Santiago, , Chile
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Santiago, , Chile
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Bucaramanga, Santander Department, Colombia
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Barranquilla, , Colombia
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Brno-Zidonice, CZE, Czechia
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Brno, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Uherské Hradiště, , Czechia
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Aalborg, , Denmark
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Copenhagen, , Denmark
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Joensuu, , Finland
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Nice, Cedex1, France
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Boulogne-Billancourt, , France
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Le Mans, , France
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Monaco, , France
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Paris, , France
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Paris, , France
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Toulouse, , France
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Bad Doberan, , Germany
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Bayreuth, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Chemnitz, , Germany
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Erlangen, , Germany
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Göttingen, , 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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Planegg, , Germany
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Ratingen, , Germany
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Thessaloniki, GR, Greece
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Athens, , Greece
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Athens, , Greece
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Haifa, , Israel
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Haifa, , Israel
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Tel Aviv, , Israel
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Nishinomiya, Hyōgo, Japan
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Kita-gun, Kagawa-ken, Japan
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Nankoku, Kochi, Japan
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Tenri, Nara, 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, Coahulia, Mexico
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Mexicali, Estado de Baja California, Mexico
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Monterrey, Nuevo León, Mexico
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Culiacan, State of Mexico, Mexico
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San Luis Potosí City, , Mexico
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Leiden, South Holland, Netherlands
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Amsterdam, , Netherlands
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Leeuwarden, , Netherlands
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Maastricht, , Netherlands
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Rotterdam, , Netherlands
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Jesus Maria, Lima region, Peru
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San Isidro, Lima region, Peru
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Santiago de Surco, Lima region, Peru
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Lima, , Peru
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Manila, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Bydgoszcz, , Poland
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Dopiewo, , Poland
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Krakow, , Poland
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Poznan, , Poland
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Sopot, , Poland
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Almada, , 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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Porto, , Portugal
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Vila Nova de Gaia, , Portugal
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Bucharest, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Barnaul, , Russia
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Chelyabinsk, , Russia
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Ivanovo, , Russia
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Kazan', , Russia
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Kemerovo, , Russia
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Kemerovo, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Petrozavodsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Ufa, , Russia
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Yaroslavl, , Russia
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Yekaterinburg, , Russia
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Bratislava, Slovak Republic, Slovakia
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Piešťany, SVK, Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Stará Ľubovňa, , Slovakia
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Seoul, Seocho Gu, South Korea
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Gwangju, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Villajoyosa, Alicante, Spain
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Bilbao, Basque Country, Spain
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San Vicente de Barakaldo, Bizkaia, Spain
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Santander, Cantabria, Spain
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Badalona, Catalonia, Spain
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Barcelona, Catalonia, 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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Vitoria-Gasteiz, Vitoria Gasteiz, Spain
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Madrid, , Spain
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Valencia, , Spain
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Taichung, Taiwan ROC, Taiwan
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Dalin, , Taiwan
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taipei, , Taiwan
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Istanbul, TUR, Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Eskişehir, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Christchurch, Dorset, United Kingdom
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London, Edmonton, United Kingdom
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London, GBR, United Kingdom
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Portsmouth, Hants, United Kingdom
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Leytonstone, London, United Kingdom
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Stoke-on-Trent, Staffordshire, United Kingdom
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Bath, , United Kingdom
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Bristol, , United Kingdom
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Leicester, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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Norwich, , United Kingdom
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Torquay, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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References
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Sieper J, Poddubnyy D. Twenty years of clinical trials in axial spondyloarthritis: what can we learn for the future? Curr Opin Rheumatol. 2021 Jul 1;33(4):363-369. doi: 10.1097/BOR.0000000000000804.
Baraliakos X, Ostergaard M, Gensler LS, Poddubnyy D, Lee EY, Kiltz U, Martin R, Sawata H, Readie A, Porter B; SURPASS Study Group. Comparison of the Effects of Secukinumab and Adalimumab Biosimilar on Radiographic Progression in Patients with Ankylosing Spondylitis: Design of a Randomized, Phase IIIb Study (SURPASS). Clin Drug Investig. 2020 Mar;40(3):269-278. doi: 10.1007/s40261-020-00886-7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Plain Language Trial Summary is available on novctrd.com
Other Identifiers
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CAIN457K2340
Identifier Type: -
Identifier Source: org_study_id
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