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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02696031




Registration number
NCT02696031
Ethics application status
Date submitted
13/10/2015
Date registered
2/03/2016
Date last updated
14/04/2020

Titles & IDs
Public title
Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis
Scientific title
A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab 150 mg in Patients With Active nr- axSpA to Evaluate the Safety,Tolerability and Efficacy up to 2 Yrs, Followed by an Opt Phase of Either 150 mg or 300 mg Randomized Dose Escalation for up to Another 2 Yrs
Secondary ID [1] 0 0
CAIN457H2315
Universal Trial Number (UTN)
Trial acronym
PREVENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-radiographic Spondyloarthritis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Secukinumab
Treatment: Drugs - Placebo
Treatment: Drugs - Secukinumab
Treatment: Drugs - Secukinumab

Experimental: Secukinumab - Secukinumab 150 mg s.c.

Placebo Comparator: Placebo - Placebo s.c.

Experimental: Experimental - Secukinumab 150 mg s.c. no load


Treatment: Drugs: Secukinumab
Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly

Treatment: Drugs: Placebo
Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly

Treatment: Drugs: Secukinumab
150 mg Secukinumab s.c. monthly

Treatment: Drugs: Secukinumab
Dose escalation to 300mg at Year 2

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of TNF naive participants who achieved an ASAS 40 response (Assessment of SpondyloArthritis International Society criteria) - ASAS40 (Assessment of SpondyloArthritis International Society criteria) response is defined as an improvement of =40% and =2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain
Timepoint [1] 0 0
Week 16
Primary outcome [2] 0 0
The proportion of TNF naive participants who achieved an ASAS 40 response (Assessment of SpondyloArthritis International Society criteria) - ASAS40 response is defined as an improvement of =40% and =2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain
Timepoint [2] 0 0
Week 52
Secondary outcome [1] 0 0
The proportion of participants who achieved an ASAS 5/6 - The ASAS 5/6 improvement criteria is an improvement of =20% in at least five of all six domains
Timepoint [1] 0 0
Week 16
Secondary outcome [2] 0 0
Change in BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) over time - The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of AS
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
Change in SF-36 (Short Form-36 Physical Component Summary) physical Component Summary over time - The SF-36 (Short Form-36 Physical Component Summary) is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
The proportion of patients to achieve a BASDAI 50 response - The BASDAI 50 is defined as an improvement of at least 50% in the BASDAI compared to baseline.
Timepoint [4] 0 0
Week 16 and 52
Secondary outcome [5] 0 0
Change in Sacroiliac Joint Edema - MRI assessment of the Sacroiliac Joint
Timepoint [5] 0 0
Week 16 and 52
Secondary outcome [6] 0 0
Change in high sensitivity C-reactive protein over time - high sensitivity C-reactive protein is measured as a marker of inflammation from blood samples during the study
Timepoint [6] 0 0
Week 16
Secondary outcome [7] 0 0
The proportion of participants who achieved an ASAS 20 response - ASAS 20 response is defined as an improvement of =40% and =2 unit on a scale of 10 in at least three of the four main domains and no worsening at all in the remaining domain
Timepoint [7] 0 0
Week 16 and 52
Secondary outcome [8] 0 0
Change in BASFI (Bath Ankylosing Spondylitis Functional Index) over time - The BASFI (Bath Ankylosing Spondylitis Functional Index) is a set of 10 questions designed to determine the degree of functional limitation in those patients with AS.
Timepoint [8] 0 0
Week 16
Secondary outcome [9] 0 0
The proportion of patients who achieved an ASAS partial remission - The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 10
Timepoint [9] 0 0
Week 16
Secondary outcome [10] 0 0
The proportion of participants who achieved an ASAS 20 response - ASAS 20 response is defined as an improvement of =20% and =1 unit on a scale of 10 in at least three of the four main domains and no worsening of =20% and =1 unit on a scale of 10 in the remaining domain
Timepoint [10] 0 0
Week 16
Secondary outcome [11] 0 0
Change in ASQoL (Ankylosing Spondylitis Quality of Life scores) over time - The ASQoL (Ankylosing Spondylitis Quality of Life scores) is an instrument to measure health-related quality of life among patients with Ankylosig spondylosrthritis
Timepoint [11] 0 0
Week 16 and 52
Secondary outcome [12] 0 0
The proportion of patients who achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) inactive disease - The Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) inactive disease criteria are defined as a value below 1.3 of a composite
Timepoint [12] 0 0
Week 52

Eligibility
Key inclusion criteria
- Male or non-pregnant, non-nursing female patients at least 18 years of age

- Diagnosis of axial spondyloarthritis according to Ankylosing SpondyloArthritis
International Society (ASAS) axial spondyloarthritis criteria

- objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal
C-reactive protein)

- active axial spondyloarthritis as assessed by total Bath Ankylosing Spondylitis
Disease Activity Index >=4 cm

- Spinal pain as measured by Bath Ankylosing Spondylitis Disease Activity Index question
#2 = 4 cm (0-10 cm) at baseline

- Total back pain as measured by Visual Analogue scale = 40 mm (0-100 mm) at baseline

- Patients should have been on at least 2 different non-steroidal anti-inflammatory
drugs with an inadequate response

- Patients who have been on a TNFa inhibitor (not more than one) must have experienced
an inadequate response
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
interleukin-17 (IL-17) or IL-17 receptor

- Pregnant or nursing (lactating) women

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Coffs Harbour
Recruitment hospital [2] 0 0
Novartis Investigative Site - Maroochydore
Recruitment hospital [3] 0 0
Novartis Investigative Site - Hobart
Recruitment hospital [4] 0 0
Novartis Investigative Site - Malvern East
Recruitment hospital [5] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
3145 - Malvern East
Recruitment postcode(s) [5] 0 0
QLD 4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Montana
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
South Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Austria
State/province [18] 0 0
Graz
Country [19] 0 0
Austria
State/province [19] 0 0
Vienna
Country [20] 0 0
Belgium
State/province [20] 0 0
Bruxelles
Country [21] 0 0
Belgium
State/province [21] 0 0
Genk
Country [22] 0 0
Belgium
State/province [22] 0 0
Gent
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Pleven
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Plovdiv
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Ruse
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Sofia
Country [27] 0 0
Czechia
State/province [27] 0 0
Czech Republic
Country [28] 0 0
Czechia
State/province [28] 0 0
CZE
Country [29] 0 0
Czechia
State/province [29] 0 0
CZ
Country [30] 0 0
Czechia
State/province [30] 0 0
Uherske Hradiste
Country [31] 0 0
France
State/province [31] 0 0
Haute Vienne
Country [32] 0 0
France
State/province [32] 0 0
Bordeaux Cedex
Country [33] 0 0
France
State/province [33] 0 0
Boulogne Billancourt
Country [34] 0 0
France
State/province [34] 0 0
Chambray les Tours
Country [35] 0 0
France
State/province [35] 0 0
Monaco
Country [36] 0 0
France
State/province [36] 0 0
Paris Cedex 14
Country [37] 0 0
France
State/province [37] 0 0
Poitiers
Country [38] 0 0
France
State/province [38] 0 0
Rouen Cedex
Country [39] 0 0
Germany
State/province [39] 0 0
Niedersachsen
Country [40] 0 0
Germany
State/province [40] 0 0
Bayreuth
Country [41] 0 0
Germany
State/province [41] 0 0
Berlin
Country [42] 0 0
Germany
State/province [42] 0 0
Cottbus
Country [43] 0 0
Germany
State/province [43] 0 0
Dresden
Country [44] 0 0
Germany
State/province [44] 0 0
Erlangen
Country [45] 0 0
Germany
State/province [45] 0 0
Freiburg
Country [46] 0 0
Germany
State/province [46] 0 0
Germering
Country [47] 0 0
Germany
State/province [47] 0 0
Hamburg
Country [48] 0 0
Germany
State/province [48] 0 0
Herne
Country [49] 0 0
Germany
State/province [49] 0 0
Hildesheim
Country [50] 0 0
Germany
State/province [50] 0 0
Kiel
Country [51] 0 0
Germany
State/province [51] 0 0
Magdeburg
Country [52] 0 0
Germany
State/province [52] 0 0
Potsdam
Country [53] 0 0
Hungary
State/province [53] 0 0
Budapest
Country [54] 0 0
Hungary
State/province [54] 0 0
Debrecen
Country [55] 0 0
Hungary
State/province [55] 0 0
Eger
Country [56] 0 0
Hungary
State/province [56] 0 0
Szeged
Country [57] 0 0
Hungary
State/province [57] 0 0
Szekesfehervar
Country [58] 0 0
Hungary
State/province [58] 0 0
Szombathely
Country [59] 0 0
Hungary
State/province [59] 0 0
Veszprem
Country [60] 0 0
Israel
State/province [60] 0 0
Haifa
Country [61] 0 0
Israel
State/province [61] 0 0
Kfar Saba
Country [62] 0 0
Israel
State/province [62] 0 0
Ramat Gan
Country [63] 0 0
Israel
State/province [63] 0 0
Tel Aviv
Country [64] 0 0
Italy
State/province [64] 0 0
VR
Country [65] 0 0
Italy
State/province [65] 0 0
Bologna
Country [66] 0 0
Italy
State/province [66] 0 0
Novara
Country [67] 0 0
Italy
State/province [67] 0 0
Padova
Country [68] 0 0
Italy
State/province [68] 0 0
Pisa
Country [69] 0 0
Japan
State/province [69] 0 0
Aichi
Country [70] 0 0
Japan
State/province [70] 0 0
Fukuoka
Country [71] 0 0
Japan
State/province [71] 0 0
Hyogo
Country [72] 0 0
Japan
State/province [72] 0 0
Kagawa
Country [73] 0 0
Japan
State/province [73] 0 0
Osaka
Country [74] 0 0
Japan
State/province [74] 0 0
Saitama
Country [75] 0 0
Japan
State/province [75] 0 0
Tokyo
Country [76] 0 0
Korea, Republic of
State/province [76] 0 0
Korea
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Seocho Gu
Country [78] 0 0
Korea, Republic of
State/province [78] 0 0
Seoul
Country [79] 0 0
Mexico
State/province [79] 0 0
Coahuila
Country [80] 0 0
Mexico
State/province [80] 0 0
Estado De Mexico
Country [81] 0 0
Mexico
State/province [81] 0 0
Jalisco
Country [82] 0 0
Mexico
State/province [82] 0 0
MEX
Country [83] 0 0
Netherlands
State/province [83] 0 0
Amsterdam
Country [84] 0 0
Netherlands
State/province [84] 0 0
Groningen
Country [85] 0 0
Netherlands
State/province [85] 0 0
Maastricht
Country [86] 0 0
Norway
State/province [86] 0 0
Kongsvinger
Country [87] 0 0
Norway
State/province [87] 0 0
Moss
Country [88] 0 0
Poland
State/province [88] 0 0
Krakow
Country [89] 0 0
Poland
State/province [89] 0 0
Poznan
Country [90] 0 0
Poland
State/province [90] 0 0
Warszawa
Country [91] 0 0
Poland
State/province [91] 0 0
Wroclaw
Country [92] 0 0
Portugal
State/province [92] 0 0
Almada
Country [93] 0 0
Portugal
State/province [93] 0 0
Braga
Country [94] 0 0
Portugal
State/province [94] 0 0
Lisboa
Country [95] 0 0
Portugal
State/province [95] 0 0
Ponte de Lima
Country [96] 0 0
Russian Federation
State/province [96] 0 0
Barnaul
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Ekaterinburg
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Kemerovo
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Moscow
Country [100] 0 0
Russian Federation
State/province [100] 0 0
Saint Petersburg
Country [101] 0 0
Russian Federation
State/province [101] 0 0
Saratov
Country [102] 0 0
Russian Federation
State/province [102] 0 0
Smolensk
Country [103] 0 0
Spain
State/province [103] 0 0
Alicante
Country [104] 0 0
Spain
State/province [104] 0 0
Andalucia
Country [105] 0 0
Spain
State/province [105] 0 0
Barcelona
Country [106] 0 0
Spain
State/province [106] 0 0
Cantabria
Country [107] 0 0
Spain
State/province [107] 0 0
Catalunya
Country [108] 0 0
Spain
State/province [108] 0 0
Comunidad Valenciana
Country [109] 0 0
Spain
State/province [109] 0 0
Galicia
Country [110] 0 0
Spain
State/province [110] 0 0
Pais Vasco
Country [111] 0 0
Spain
State/province [111] 0 0
Pontevedra
Country [112] 0 0
Spain
State/province [112] 0 0
Madrid
Country [113] 0 0
Sweden
State/province [113] 0 0
Goteborg
Country [114] 0 0
Sweden
State/province [114] 0 0
Lund
Country [115] 0 0
Sweden
State/province [115] 0 0
Uppsala
Country [116] 0 0
Switzerland
State/province [116] 0 0
Basel
Country [117] 0 0
Switzerland
State/province [117] 0 0
Fribourg
Country [118] 0 0
Turkey
State/province [118] 0 0
Ankara
Country [119] 0 0
Turkey
State/province [119] 0 0
Istanbul
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Essex
Country [121] 0 0
United Kingdom
State/province [121] 0 0
Grampian Region
Country [122] 0 0
United Kingdom
State/province [122] 0 0
London
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Staffordshire
Country [124] 0 0
United Kingdom
State/province [124] 0 0
West Sussex
Country [125] 0 0
United Kingdom
State/province [125] 0 0
Bath
Country [126] 0 0
United Kingdom
State/province [126] 0 0
Doncaster
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Dundee
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Middlesborough
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Northampton
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to
placebo in patients with nr-axSpA at Week 16 as well as Week 52 and long term efficacy and
safety up to Week 104 followed by an optional 16-week randomized dose escalation treatment
period and a continuous treatment period for up to Week 208
Trial website
https://clinicaltrials.gov/show/NCT02696031
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications