Extension in AS: Sustainability of Benefits, Safety and Tolerability

Spondylitis, Ankylosing Clinical Trial

— MEASURE 1 ext  

Official title:

An Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01863732
• Other study ID #: CAIN457F2305E1
• Secondary ID: 2013-001089-40
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Spondylitis
• Spondylitis, Ankylosing

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

External Links

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