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

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ClinicalTrials.gov Identifier: NCT01863732
Recruitment Status : Active, not recruiting
First Posted : May 29, 2013
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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 or disease Intervention/treatment Phase
Spondylitis, Ankylosing Biological: Secukinumab Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 274 participants
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
Actual Study Start Date : November 6, 2013
Estimated Primary Completion Date : January 26, 2018
Estimated Study Completion Date : February 15, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Secukinumab
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.



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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.

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

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01863732     History of Changes
Other Study ID Numbers: CAIN457F2305E1
2013-001089-40 ( EudraCT Number )
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

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