Efficacy at 16 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Ankylosing Spondylitis	Biological: Secukinumab (75 mg) Biological: Secukinumab (150 mg) Biological: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis

Resource links provided by NLM:

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Efficacy of each secukinumab regimen is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response in the subgroup of patients who are TNFα inhibitor naïve [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Efficacy of each secukinumab regimen is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 (Assessment of Spondyloarthritis International Society criteria) response in the subgroup of patients who are TNFα inhibitor naïve

Secondary Outcome Measures:

Efficacy of each secukinumab regimen is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response in the whole study population [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Efficacy of each secukinumab regimen is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 40 response in patients who are TNFα inhibitor naïve [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Efficacy of each secukinumab regimen is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 40 response in the whole study population [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Spinal mobility assessed by Bath Ankylosing Spondylitis Metrology Index (BASMI) linear scores [ Time Frame: Week 2, 12, 16 and over time up to 2 years of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	348
Study Start Date:	July 2011
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1	Biological: Secukinumab (75 mg) Secukinumab (75 mg)
Experimental: Group 2	Biological: Secukinumab (150 mg) Secukinumab (150 mg)
Placebo Comparator: Group 3	Biological: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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-TNFα 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 TNFα
Previous treatment with any cell-depleting therapies
Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358175

Contacts

Contact: Novartis Pharmaceuticals

862-778-8300

Locations

Bulgaria
Novartis Investigative Site	Not yet recruiting
Sofia, Bulgaria
Contact: Novartis Pharmaceuticals 41613241111
Netherlands
Novartis Investigative Site	Not yet recruiting
Amsterdam, Netherlands
Contact: Novartis Pharmaceuticals 41613241111
Novartis Investigative Site	Not yet recruiting
Utrecht, Netherlands
Contact: Novartis Pharmaceuticals 41613241111
United Kingdom
Novartis Investigative Site	Not yet recruiting
Blackpool, United Kingdom, FY38NR
Contact: Novartis Pharmaceuticals 41613241111
Novartis Investigative Site	Not yet recruiting
Cambridge, United Kingdom, CB22QQ
Contact: Novartis Pharmaceuticals 41613241111
Novartis Investigative Site	Recruiting
London, United Kingdom, E111NR
Contact: Novartis Pharmaceuticals 41613241111
Novartis Investigative Site	Not yet recruiting
Newcastle, United Kingdom, NE77DN
Contact: Novartis Pharmaceuticals 41613241111
Novartis Investigative Site	Not yet recruiting
Wolverhampton, United Kingdom, WV1DDQP
Contact: Novartis Pharmaceuticals 41613241111

Sponsors and Collaborators

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01358175 History of Changes
Other Study ID Numbers:	CAIN457F2305, 2010-024529-18
Study First Received:	May 19, 2011
Last Updated:	January 15, 2013
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products Bulgaria: Bulgarian Drug Agency Canada: Canadian Institutes of Health Research France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Italy: Ethics Committee Mexico: Federal Commission for Sanitary Risks Protection Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Peru: Ministry of Health Russia: Ministry of Health of the Russian Federation Taiwan : Food and Drug Administration Turkey: Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration

Keywords provided by Novartis:

Ankylosing spondylitis
AS
ASAS
inflammatory back pain

Additional relevant MeSH terms:

Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases

Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on May 23, 2013

Efficacy at 16 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Ankylosing Spondylitis (AS) (MEASURE 1)