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Extension in AS: Sustainability of Benefits, Safety and Tolerability (MEASURE 1 ext)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01863732
First Posted: May 29, 2013
Last Update Posted: August 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This 3-year extension study aims at making available the treatment with secukinumab in prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III study CAIN457F2305, defined as "core study", as well as to generate additional data on the sustainability of clinical benefits, safety and tolerability during long-term administration of secukinumab.

Condition Intervention Phase
Spondylitis, Ankylosing Biological: Secukinumab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Extension Study to Evaluate the Sustainability of Clinical Benefits, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Assessment of Spondyloarthritis International Society criteria / ASAS 20 response [ Time Frame: 260 weeks (including the 2-year duration of the "core study" CAIN457F2305) ]
    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 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period.


Secondary Outcome Measures:
  • ASAS 40 response [ Time Frame: 260 weeks (including the 2-year duration of the "core study" CAIN457F2305) ]
    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 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period.

  • Overall safety and tolerability [ Time Frame: 260 weeks (including the 2-year duration of the "core study" CAIN457F2305) ]
    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 immunogenicity.


Enrollment: 274
Study Start Date: November 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Secukinumab 75 mg
Secukinumab in PFS for s.c. self-administration Q4W
Biological: Secukinumab
Eligible patients having completed the core study continue in the extension study under the same blinded dosage regimen (1 PFS); because of the double dummy design, placebo containing PFS is administered simultaneously, for a total of two injections. As of week 156, the same dosage regimen is administered open label, thus a single injection takes place.
Other Name: AIN457
Experimental: Secukinumab 150 mg
Secukinumab in PFS for s.c. self-administration Q4W
Biological: Secukinumab
Eligible patients having completed the core study continue in the extension study under the same blinded dosage regimen (1 PFS); because of the double dummy design, placebo containing PFS is administered simultaneously, for a total of two injections. As of week 156, the same dosage regimen is administered open label, thus a single injection takes place.
Other Name: AIN457

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria: patients having completed the "core study" CAIN457F2305, indication for treatment extension. -- Exclusion Criteria: history of hypersensitivity to secukinumab or to any drug of similar chemical classes, use of any investigational drug other than secukinumab during the "core study" CAIN457F2305.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863732


  Show 56 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01863732     History of Changes
Other Study ID Numbers: CAIN457F2305E1
2013-001089-40 ( EudraCT Number )
First Submitted: May 23, 2013
First Posted: May 29, 2013
Last Update Posted: August 5, 2016
Last Verified: August 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
AIN457, ankylosing spondylitis, chronic inflammatory disease, inflammatory back pain, PFS, pre-filled syringe, secukinumab, self-injection

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs


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