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

This study is not yet open for participant recruitment.
Verified July 2012 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01649375
First received: July 20, 2012
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  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 non steroidal antiinflamatory drugs (NSAIDs), disease-modifying antirheumatic drugs 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:

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: August 2012
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 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(862)778-8300

Locations
United States, California
Novartis Investigative Site Not yet recruiting
Upland, California, United States, 91786
Italy
Novartis Investigative Site
Valeggio Sul Mincio, (vr), Italy, 37067
Novartis Investigative Site
Bergamo, BG, Italy, 24128
Novartis Investigative Site
Catania, CT, Italy, 95100
Novartis Investigative Site
Torino, TO, Italy, 10128
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals 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: July 24, 2012
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
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 16, 2013