Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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30 March 2021 |
Main ID: |
EUCTR2015-001106-33-BE |
Date of registration:
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30/03/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of efficacy and safety of secukinumab in patients with non-radiographic axial spondyloarthritis
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Scientific title:
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A randomized, double-blind, placebo-controlled multicenter study of
secukinumab 150 mg in patients with active non-radiographic axial
spondyloarthritis to evaluate the safety, tolerability and efficacy up to 2
years, followed by an optimal phase of either 150 mg or 300 mg
randomized dose escalation for up to another 2 years
- PREVENT |
Date of first enrolment:
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07/06/2016 |
Target sample size:
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555 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001106-33 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Austria
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Belgium
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Bulgaria
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Czech Republic
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France
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Germany
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Hungary
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Israel
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Italy
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Japan
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Monaco
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Netherlands
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Norway
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Poland
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Portugal
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Russian Federation
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Spain
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Sweden
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trial Information Desk
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Address:
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Forum 1, Novartis Campus
4056
Basel
Switzerland |
Telephone:
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+4161 324 1111 |
Email:
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clinicaltrial.enquiries@novartis.com |
Affiliation:
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Novartis Pharma AG |
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Name:
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Clinical Trial Information Desk
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Address:
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Forum 1, Novartis Campus
4056
Basel
Switzerland |
Telephone:
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+4161 324 1111 |
Email:
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clinicaltrial.enquiries@novartis.com |
Affiliation:
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Novartis Pharma AG |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Male or non-pregnant, non-nursing female patients at least 18 years of age
• Diagnosis of axSpA according to ASAS axSpA criteria
• Objective signs of inflammation (MRI or abnormal CRP)
• Active axSpA as assessed by total BASDAI >=4 cm
• Spinal pain as measured by BASDAI question #2 = 4 cm (0-10 cm) at baseline
• Total back pain as measured by VAS = 40 mm (0-100 mm) at baseline
• Patients should have been on at least 2 different NSAIDs with an inadequate response
• Patients who have been on a TNFa inhibitor (not more than one) must have experienced an inadequate response
For the extension phase of the study:
• Patients who have completed the full study treatment period (104
weeks) in the core phase on study treatment.
• Other protocol-defined inclusion criteria may apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 505 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria: • Patients with radiographic evidence for sacroiliitis, grade = 2 bilaterally or grade = 3 unilaterally
• Inability or unwillingness to undergo MRI
• Chest X-ray or MRI with evidence of ongoing infectious or malignant process
• Patients taking high potency opioid analgesics
• Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor
• Pregnant or nursing (lactating) women
• Other protocol-defined exclusion criteria may apply
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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non-radiographic axial spondyloarthritis MedDRA version: 20.0
Level: LLT
Classification code 10076297
Term: Non-radiographic axial spondyloarthritis
System Organ Class: 100000004859
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Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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Intervention(s)
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Trade Name: COSENTYX Product Name: Secukinumab Product Code: AIN457 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Secukinumab CAS Number: 1229022-83-6 Current Sponsor code: AIN457 Other descriptive name: SECUKINUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Main Objective: To demonstrate superiority of secukinumab 150 mg sc with loading over placebo at Week 16, based on the proportion of TNF naïve patients achieving an ASAS40 response (Assessment of SpondyloArthritis International Society criteria).
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Timepoint(s) of evaluation of this end point: Week 16
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Primary end point(s): The proportion of TNF naïve patients achieving an ASAS 40 response (Assessment of SpondyloArthritis International Society criteria)
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Secondary Objective: -To demonstrate that the efficacy of secukinumab 150 mg sc: •with or without loading, at W16 is superior to pbo based on the proportion of all patients achieving an ASAS40 response •without loading, at W16 is superior to pbo based on the proportion of TNF naïve patients achieving an ASAS40 response. -To demonstrate that the efficacy of secukinumab 150mg sc, with or without a loading, at W16 is superior to pbo based on: • the proportion of patients meeting the ASAS 5/6 response criteria • the change from baseline in total BASDAI • the proportion of patients achieving BASDAI 50 • the change from baseline of hsCRP • the change from baseline in total BASFI • the change from screening in SI joint edema on MRI • the proportion of subjects achieving an ASAS20 response • the change from baseline in SF-36 PCS • the change from baseline in ASQoL • the proportion of patients achieving ASAS partial remission -Overall safety and tolerability of secukinumab
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Secondary Outcome(s)
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Secondary end point(s): - The proportion of all patients achieving an ASAS40 response (a)
- The proportion of TNF naïve patients achieving an ASAS40 response (a)
- The proportion of patients meeting the ASAS 5/6 response criteria (a)
- Change in BASDAI over time (a)
- The proportion of patients achieving a BASDAI 50 response (a)
- Change in hsCRP over time (a)
- Change in BASFI over time (a)
- Change in SI Joint Edema (a)
- The proportion of patients achieving an ASAS20 response (a)
- Change in SF-36 physical Component Summary over time (a)
- Change in ASQoL over time (a)
- The proportion of patients achieving an ASAS partial remission (a)
- Safety and tolerability (b)
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Timepoint(s) of evaluation of this end point: (a) Week 16
(b) Week 112
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Secondary ID(s)
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2015-001106-33-DE
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CAIN457H2315
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Ethics review
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Status: Approved
Approval date: 07/06/2016
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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