16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

— MEASURE 1  

Official title:

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the 16 Week Efficacy and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01358175
• Other study ID #: CAIN457F2305
• Secondary ID: 2010-024529-18
• Status: Active, not recruiting
• Phase: Phase 3
• First received: May 19, 2011
• Last updated: October 24, 2014
• Start date: October 2011
• Est. completion date: February 2015

Study information

• Verified date: October 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsBulgaria: Bulgarian Drug AgencyCanada: Canadian Institutes of Health ResearchFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: Ethics CommitteeMexico: Federal Commission for Sanitary Risks ProtectionNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Peru: Ministry of HealthRussia: Ministry of Health of the Russian FederationTaiwan : Food and Drug AdministrationTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 372
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Male or non-pregnant, non-lactating female patients at least 18 years of age

• Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984)

• Patients should have been on NSAIDs with an inadequate response

• Patients who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose

• Patients who have been on an anti-TNFa agent (not more than one) must have experienced an inadequate response

Exclusion criteria:

• Chest X-ray with evidence of ongoing infectious or malignant process

• Patients with total ankylosis of the spine

• Patients previously treated with any biological immunomodulating agents except for those targeting TNFa

• Previous treatment with any cell-depleting therapies

• Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Secukinumab (75 mg)
Secukinumab (75 mg)
• Secukinumab (150 mg)
Secukinumab (150 mg)
• Placebo
Placebo

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	Toronto	Ontario
Canada	Novartis Investigative Site	Winnipeg	Manitoba
France	Novartis Investigative Site	Bordeaux Cedex
France	Novartis Investigative Site	Limoges
France	Novartis Investigative Site	Paris
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Herne
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Nürnberg
Germany	Novartis Investigative Site	Ratingen
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
Italy	Novartis Investigative Site	Valeggio Sul Mincio	(vr)
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 León
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	Istanbul
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	Austin	Texas
United States	Novartis Investigative Site	Benbrook	Texas
United States	Novartis Investigative Site	Boise	Idaho
United States	Novartis Investigative Site	Cedar Rapids	Iowa
United States	Novartis Investigative Site	Dallas	Texas
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 / ASAS 20 response	ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.	16 weeks	No
Secondary	ASAS 40 response	ASAS 40 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 40% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 40 is used to assess the efficacy of at least one dose of secukinumab against placebo.	16 weeks	No
Secondary	Serum hsCRP	Blood levels of C-reactive protein (CRO), an acute phase reactant, are indicative of inflammation and of its severity, and can be used to monitor treatment response. A high sensitvity CRP (hsCRP) test is implemented in this study to assess the efficacy of at least one dose of secukinumab versus placebo in reducing AS elicited systemic inflammation over time.	Week 16	No
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 timeframe at least 20% improvement in score in at least 5 of a conventional set of 6 clinical domains relevent to AS and no worsening in the remaining domain. In this study, ASAS 5/6 is used to assess the efficacy of at least one dose of secukinumab against placebo.	16 weeks	No
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 characterize 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 is used to assess the efficacy of at least one dose of secukinumab verus placebo.	16 weeks	No
Secondary	Physical function component of the short-form health survey / SF-36 PCS	SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both phyically and emotionally based. Two overall summary scores, the Phyical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.	16 weeks	No
Secondary	Ankylosing Spondylitis Quality of Life questionnaire / ASQoL	ASQoL is an 18 item questionnaire that assesses disease-specific quality of life (QoL), consisting of statements that are relevant to the physical and mental conditions for a participant with AS: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each statement is answered by the participant as a 'Yes' (scored as 1) or 'No' (scored as 0). All item scores are summed to give a total score. Total score can range from 0 (good QoL) to 18 (poor QoL). In this study, ASQoL is used to assess improvement from baseline of at least one dose of secukinumab versus placebo.	16 weeks	No
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 is used to assess the efficacy of at least one dose of secukinumab versus placebo.	16 weeks	No
Secondary	Overall safety and tolerability	These assessments will be implemented in terms of physical examination and vital signs outcomes, clinical laboratory results, nature and frequency of the observed adverse events and serious adverse events, frequency and severity of any injection site reactions, ECG outcomes and the detection of immunogencity. During the first 16 weeks of the study, comparisons between the secukinumab treatment arms and the placebo treatment arm will also take place.	104 weeks	Yes