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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01863732
First received: May 23, 2013
Last updated: June 19, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 300
Study Start Date: November 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01863732

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

  Show 62 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01863732     History of Changes
Other Study ID Numbers: CAIN457F2305E1, 2013-001089-40
Study First Received: May 23, 2013
Last Updated: June 19, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
France: National Agency for the Safety of Medicines and Health Products (MSNA)
Germany: Paul-Ehrlich-Institut
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Russia: Ministry of Health of the Russian Federation
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Turkey: Ministry of Health
United States: Food and Drug Administration
Mexico: Federal Commission for Sanitary Risks Protection
Taiwan: Department of Health

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

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

ClinicalTrials.gov processed this record on September 18, 2014