Spondylitis, Ankylosing Clinical Trial
— MEASURE 1 extOfficial title:
An Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis
Verified date | June 2019 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 274 |
Est. completion date | March 16, 2018 |
Est. primary completion date | March 16, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Novartis Investigative Site | Bruxelles | |
Belgium | Novartis Investigative Site | Genk | |
Belgium | Novartis Investigative Site | Gent | |
Belgium | Novartis Investigative Site | Leuven | |
Bulgaria | Novartis Investigative Site | Burgas | |
Bulgaria | Novartis Investigative Site | Plovdiv | |
Bulgaria | Novartis Investigative Site | Plovdiv | |
Bulgaria | Novartis Investigative Site | Sofia | |
Bulgaria | Novartis Investigative Site | Sofia | |
Canada | Novartis Investigative Site | St. John's | Newfoundland and Labrador |
Canada | Novartis Investigative Site | Winnipeg | Manitoba |
France | Novartis Investigative Site | Bordeaux Cedex | |
France | Novartis Investigative Site | Limoges cedex | Haute Vienne |
France | Novartis Investigative Site | Paris | |
Germany | Novartis Investigative Site | Berlin | |
Germany | Novartis Investigative Site | Erlangen | |
Germany | Novartis Investigative Site | Hamburg | |
Germany | Novartis Investigative Site | Herne | |
Germany | Novartis Investigative Site | Koeln | |
Germany | Novartis Investigative Site | Magdeburg | |
Germany | Novartis Investigative Site | Nürnberg | |
Italy | Novartis Investigative Site | Brescia | BS |
Italy | Novartis Investigative Site | Catania | CT |
Italy | Novartis Investigative Site | Palermo | PA |
Italy | Novartis Investigative Site | Siena | SI |
Italy | Novartis Investigative Site | Torino | TO |
Mexico | Novartis Investigative Site | Culiacan | Sinaloa |
Mexico | Novartis Investigative Site | Guadalajara | Jalisco |
Mexico | Novartis Investigative Site | Mexicali | Baja California |
Mexico | Novartis Investigative Site | Monterrey | Nuevo Leon |
Netherlands | Novartis Investigative Site | Amsterdam | |
Netherlands | Novartis Investigative Site | Utrecht | |
Peru | Novartis Investigative Site | Jesus Maria | Lima |
Peru | Novartis Investigative Site | La Victoria | Lima |
Peru | Novartis Investigative Site | Pueblo Libre | Lima |
Peru | Novartis Investigative Site | San Isidro | Lima |
Peru | Novartis Investigative Site | Surquillo | Lima |
Russian Federation | Novartis Investigative Site | Ekaterinburg | |
Russian Federation | Novartis Investigative Site | Ekaterinburg | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Saint Petersburg | |
Russian Federation | Novartis Investigative Site | Tula | |
Russian Federation | Novartis Investigative Site | Yaroslavl | |
Taiwan | Novartis Investigative Site | Kaohsiung | |
Taiwan | Novartis Investigative Site | Taichung | Taiwan ROC |
Turkey | Novartis Investigative Site | Gaziantep | |
Turkey | Novartis Investigative Site | Izmir | |
United Kingdom | Novartis Investigative Site | Cambridge | |
United Kingdom | Novartis Investigative Site | London | England |
United Kingdom | Novartis Investigative Site | Newcastle Upon Tyne | |
United Kingdom | Novartis Investigative Site | Wolverhampton | |
United States | Novartis Investigative Site | Duncansville | Pennsylvania |
United States | Novartis Investigative Site | Jackson | Tennessee |
United States | Novartis Investigative Site | Kingsport | Tennessee |
United States | Novartis Investigative Site | Portland | Oregon |
United States | Novartis Investigative Site | Spokane | Washington |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States, Belgium, Bulgaria, Canada, France, Germany, Italy, Mexico, Netherlands, Peru, Russian Federation, Taiwan, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Week 104 to Week 260 | |
Secondary | 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 | Week 104 to Week 260 |
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