16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients

Spondylitis, Ankylosing Clinical Trial

— MEASURE 3  

Official title:

A Randomized, Double-blind, Placebo-controlled Phase III Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long-term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008916
• Other study ID #: CAIN457F2314
• Secondary ID: 2013-001090-24
• Status: Completed
• Phase: Phase 3
• Start date: January 14, 2014
• Est. completion date: December 11, 2017

Study information

• Verified date: December 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: December 11, 2017
• Est. primary completion date: February 23, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the Modified NY Criteria (1984), inadequate response to NSAIDs. -- Exclusion criteria: pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI, previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any biological immunomodulating agent excluding TNF antagonists, previous cell depleting therapy.

Related Conditions & MeSH terms

• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Secukinumab
AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17).
• Placebo secukinumab
Placebo to AIN457 (Secukinumab)

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Aalst
Belgium	Novartis Investigative Site	Bruxelles
Czechia	Novartis Investigative Site	Praha 2
Czechia	Novartis Investigative Site	Uherske Hradiste	Czech Republic
Germany	Novartis Investigative Site	Bad Doberan
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Cottbus
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Gottingen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Herne
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Zerbst
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Heraklion
Greece	Novartis Investigative Site	Thessaloniki	GR
Mexico	Novartis Investigative Site	Culiacan	MEX
Mexico	Novartis Investigative Site	Mexicali	Baja California
Mexico	Novartis Investigative Site	Torreon	Coahuila
Portugal	Novartis Investigative Site	Almada
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Lisboa
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	St Petersburg
Russian Federation	Novartis Investigative Site	St-Petersburg
Spain	Novartis Investigative Site	Cordoba	Andalucia
Spain	Novartis Investigative Site	El Palmar	Murcia
Spain	Novartis Investigative Site	La Coruna	Galicia
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Sabadell	Barcelona
Spain	Novartis Investigative Site	Santander	Cantabria
United Kingdom	Novartis Investigative Site	London	England
United Kingdom	Novartis Investigative Site	Norwich
United Kingdom	Novartis Investigative Site	Torquay
United States	Novartis Investigative Site	Albany	New York
United States	Novartis Investigative Site	Austin	Texas
United States	Novartis Investigative Site	Charleston	South Carolina
United States	Novartis Investigative Site	Duncansville	Pennsylvania
United States	Novartis Investigative Site	Jackson	Tennessee
United States	Novartis Investigative Site	Mesa	Arizona
United States	Novartis Investigative Site	Mesquite	Texas
United States	Novartis Investigative Site	Mobile	Alabama
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Palm Harbor	Florida
United States	Novartis Investigative Site	Passaic	New Jersey
United States	Novartis Investigative Site	Pembroke Pines	Florida
United States	Novartis Investigative Site	Peoria	Arizona
United States	Novartis Investigative Site	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Czechia,  Germany,  Greece,  Mexico,  Portugal,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With 20% Improvement in the Assessment of Spondyloarthritis International Society Criteria Scale / ASAS 20 Response	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 was used to assess the efficacy of at least one dose of secukinumab versus placebo.	16 weeks
Secondary	ASAS 40 Response	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 was used to assess the efficacy of at least one dose of secukinumab versus placebo.	16 weeks
Secondary	Serum hsCRP	Blood levels of C-reactive protein (CRP), an acute phase reactant, are indicative of inflammation and of its severity, and can be used to monitor treatment response. A high sensitivity CRP (hsCRP) test was implemented in this study, to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over the time.	Baseline and 16 weeks
Secondary	ASAS 5/6 Response	ASAS 5/6 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 5 of a conventional set of 6 clinical domains relevant to AS and no worsening in the remaining domain. In this study, ASAS 5/6 was used to assess the efficacy of at least one dose of secukinumab versus placebo.	16 weeks
Secondary	Bath Ankylosing Spondylitis Disease Activity Index / BASDAI	BASDAI is a validated assessment tool using 0 through 10 scales (0 indicating "no problem" and 10 indicating "worst problem"), to characterise six clinical domains pertaining to five major symptoms of AS perceived by the patients. Computed composite scores of 4 or greater indicate suboptimal disease control. In this study, the BASDAI index was used to assess the efficacy of at least one dose of secukinumab versus placebo.	Baseline and 16 weeks
Secondary	Number of Participants With Successful Self-administration (to Measure Usability of Pre-filled Syringe)	Successful self-administration is defined as success in steps P8 (Removed Needle Cap from Safety Syringe), P10 (Pinched the Skin at Injection Site), P11 (Inserted the Needle into Skin), P12 (Held onto the Finger Flange), P13 (Fully Depressed Plunger until End Point), and P14 (Held Plunger Down and Syringe in Place) of the Instructions for Use, as observed by the site staff at applicable visits.	Week 8 and Week 12
Secondary	Pre-filled Syringe Possible Hazard	The number and percentage of subjects who experience any of the defined possible hazards are summarized, as defined in the Possible Hazard assessment check list and as observed by the site staff at applicable visits.	Week 8 and Week 12
Secondary	Prefilled Syringe Patient Satisfaction Assessment	The self-injection assessment questionnaire (SIAQ) measures overall patient experience with subcutaneous self-injection at applicable visits. Domain scores ranging from 0 (worst experience) to 10 (best experience) are presented: Feeling about injections, Self-confidence, Satisfaction with self-injection.	Baseline, weeks 8, 12 and 16
Secondary	ASAS Partial Remission	ASAS partial remission is a composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame a value not above 2 units in each of the 4 ASAS domains on a scale of 10. In this study, ASAS partial remission was used to assess the efficacy of at least one dose of secukinumab versus placebo.	16 weeks

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