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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01863732
Other study ID # CAIN457F2305E1
Secondary ID 2013-001089-40
Status Completed
Phase Phase 3
First received
Last updated
Start date November 6, 2013
Est. completion date March 16, 2018

Study information

Verified date June 2019
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Secukinumab
Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W
Other:
Placebo (Pbo)
Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  France,  Germany,  Italy,  Mexico,  Netherlands,  Peru,  Russian Federation,  Taiwan,  Turkey,  United Kingdom, 

Outcome

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
See also
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