Efficacy at 16 Weeks and Long Term Efficacy, Safety and Tolerability up to 5 Years of Secukinumab in Patients With Active Ankylosing Spondylitis - Full Text View

Purpose

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

Condition	Intervention	Phase
Ankylosing Spondylitis	Biological: AIN457 Biological: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Double-blind, Placebo-controlled Phase III Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 16 Weeks and to Assess the Long-term Efficacy, Safety and Tolerability up to 5 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:

Proportion of subjects achieving ASAS 20 response at week 16 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Primary endpoint is proportion of subjects achieving an ASAS 20 (Assessment of SpondyloArthritis International Society criteria) response at week 16 in subgroup of patients who are TNFα inhibitor naïve compared to placebo. ASAS Response Criteria is defined as an improvement of at least 20% and absolute improvement of at least 10 units on a 0-100mm scale in at least 3 of 4 assessment domains (1. subject's global assessment of disease activity 2. subject's assessment of inflammatory back pain 3. function represented by BASFI VAS 4. morning stiffness represented by the last 2 questions on BASDAI)

Secondary Outcome Measures:

Proportion of subjects achieving ASAS 20 response at week 16 in whole study population [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Proportion of patients achieving an ASAS 20 response in the whole study population compared to placebo at week 16. The ASAS Response Criteria is defined as an improvement of at least 20% and absolute improvement of at least 10 units on a 0-100mm scale in at least 3 of 4 assessment domains (1. subject's global assessment of disease activity 2. subject's assessment of inflammatory back pain 3. function represented by BASFI VAS 4. morning stiffness represented by the last 2 questions on BASDAI)
Proportion of subjects achieving ASAS 40 response at week 16 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Proportion of subjects achieving an ASAS 40 response at week 16 in subgroup of patients who are TNFα inhibitor naïve compared to placebo. ASAS Response Criteria is defined as an improvement of at least 40% and absolute improvement of at least 10 units on a 0-100mm scale in at least 3 of 4 assessment domains (1. subject's global assessment of disease activity 2. subject's assessment of inflammatory back pain 3. function represented by BASFI VAS 4. morning stiffness represented by the last 2 questions on BASDAI)
Proportion of subjects achieving ASAS 40 response at week 16 in whole study population [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Proportion of patients achieving an ASAS 40 response in the whole study population compared to placebo at week 16. The ASAS Response Criteria is defined as an improvement of at least 40% and absolute improvement of at least 10 units on a 0-100mm scale in at least 3 of 4 assessment domains (1. subject's global assessment of disease activity 2. subject's assessment of inflammatory back pain 3. function represented by BASFI VAS 4. morning stiffness represented by the last 2 questions on BASDAI)

Estimated Enrollment:	222
Study Start Date:	March 2012
Estimated Study Completion Date:	September 2018
Estimated Primary Completion Date:	September 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AIN457 75 mg	Biological: AIN457
Experimental: AIN457 150 mg	Biological: AIN457
Placebo Comparator: Placebo	Biological: Placebo secukinumab placebo provided in 0.5 mL/1.0 mL prefilled syringe for subcutaneous injection

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
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 (or MRI) 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: NCT01649375

Contacts

Contact: Novartis Pharmaceuticals, 862-778-8300	1-888-669-6682
Contact: Novartis Pharmaceuticals

Show 79 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01649375 History of Changes
Other Study ID Numbers:	CAIN457F2310, 2012-000046-35
Study First Received:	July 20, 2012
Last Updated:	May 21, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Ankylosing spondylitis
AS
Chronic inflammatory disease
Inflammatory back pain
Secukinumab

Prefilled syringe (PFS)
Subcutaneous injection
AIN457
AIN457F

Additional relevant MeSH terms:

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

Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on June 13, 2013