- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02696031
Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis (PREVENT)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients were randomized to one of three treatment groups (1:1:1) in the core phase:
- Secukinumab 150 mg Load: secukinumab 150 mg (1 mL, 150 mg/mL) s.c. pre-filled syringe (PFS) at baseline, Weeks 1, 2, and 3, followed by administration every four weeks starting at Week 4
- Secukinumab 150 mg No Load: secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS at baseline, placebo at Weeks 1, 2, and 3, followed by secukinumab 150 mg PFS administration every four weeks starting at Week 4
- Placebo: placebo (1 mL) s.c. PFS at baseline, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4.
All patients received secukinumab 150 mg as open-label treatment from Week 52 up to Week 100, unless they had discontinued study treatment.
At Week 104, all patients who finished the core phase according to the protocol were asked to continue in an optional, exploratory extension phase. Patients who achieved ASAS20 response at Week 104 (Core Phase Responders) were randomized to the following treatment groups (blinded) in the extension phase:
- Core Phase Responder 150 mg: secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS and placebo (1 mL) s.c. PFS every four weeks;
- Core Phase Responder 300 mg: 2 injections with secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS every four weeks.
Core Phase Non-Responders (not achieving ASAS20 at Week 104) were escalated to secukinumab 300 mg in an open-label manner.
- Core Phase Non-Responder 300 mg: 2 injections with secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS every four weeks open-label.
Starting from Week 156 onward, a patient could switch to secukinumab 300 mg open-label based on the clinical judgment of disease activity by the investigator.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Woolloongabba, Australia, QLD 4102
- Novartis Investigative Site
-
-
New South Wales
-
Coffs Harbour, New South Wales, Australia, 2450
- Novartis Investigative Site
-
-
Queensland
-
Maroochydore, Queensland, Australia, 4558
- Novartis Investigative Site
-
-
Tasmania
-
Hobart, Tasmania, Australia, 7000
- Novartis Investigative Site
-
-
Victoria
-
Malvern East, Victoria, Australia, 3145
- Novartis Investigative Site
-
-
-
-
-
Graz, Austria, 8036
- Novartis Investigative Site
-
Vienna, Austria, A-1060
- Novartis Investigative Site
-
-
-
-
-
Bruxelles, Belgium, 1200
- Novartis Investigative Site
-
Genk, Belgium, 3600
- Novartis Investigative Site
-
Gent, Belgium, 9000
- Novartis Investigative Site
-
-
-
-
-
Pleven, Bulgaria, 5800
- Novartis Investigative Site
-
Sofia, Bulgaria, 1606
- Novartis Investigative Site
-
Sofia, Bulgaria, 1784
- Novartis Investigative Site
-
-
-
-
-
Uherske Hradiste, Czechia, 686 01
- Novartis Investigative Site
-
-
CZ
-
Brno, CZ, Czechia, 625 00
- Novartis Investigative Site
-
-
CZE
-
Brno-Zidonice, CZE, Czechia, 61500
- Novartis Investigative Site
-
-
Czech Republic
-
Praha 11, Czech Republic, Czechia, 148 00
- Novartis Investigative Site
-
Praha 2, Czech Republic, Czechia, 128 50
- Novartis Investigative Site
-
Praha 5, Czech Republic, Czechia, 150 06
- Novartis Investigative Site
-
-
-
-
-
Bordeaux Cedex, France, 33076
- Novartis Investigative Site
-
Boulogne Billancourt, France, 92104
- Novartis Investigative Site
-
Chambray les Tours, France, 37170
- Novartis Investigative Site
-
Monaco, France, 98000
- Novartis Investigative Site
-
Paris Cedex 14, France, 75679
- Novartis Investigative Site
-
Poitiers, France, 86021
- Novartis Investigative Site
-
Rouen Cedex, France, 76031
- Novartis Investigative Site
-
-
Haute Vienne
-
Limoges cedex, Haute Vienne, France, 87000
- Novartis Investigative Site
-
-
-
-
-
Berlin, Germany, 13125
- Novartis Investigative Site
-
Berlin, Germany, 13353
- Novartis Investigative Site
-
Cottbus, Germany, 03042
- Novartis Investigative Site
-
Dresden, Germany, 01307
- Novartis Investigative Site
-
Erlangen, Germany, 91054
- Novartis Investigative Site
-
Freiburg, Germany, 79106
- Novartis Investigative Site
-
Hamburg, Germany, 22415
- Novartis Investigative Site
-
Hamburg, Germany, 22143
- Novartis Investigative Site
-
Hamburg, Germany, 22767
- Novartis Investigative Site
-
Herne, Germany, 44649
- Novartis Investigative Site
-
Magdeburg, Germany, 39110
- Novartis Investigative Site
-
Potsdam, Germany, 14469
- Novartis Investigative Site
-
-
Niedersachsen
-
Hannover, Niedersachsen, Germany, 30159
- Novartis Investigative Site
-
-
-
-
-
Budapest, Hungary, 1027
- Novartis Investigative Site
-
Debrecen, Hungary, 4032
- Novartis Investigative Site
-
Eger, Hungary, 3300
- Novartis Investigative Site
-
Szeged, Hungary, 6720
- Novartis Investigative Site
-
Szekesfehervar, Hungary, 8000
- Novartis Investigative Site
-
Veszprem, Hungary, 8200
- Novartis Investigative Site
-
-
-
-
-
Haifa, Israel, 3109601
- Novartis Investigative Site
-
Kfar Saba, Israel, 4428164
- Novartis Investigative Site
-
Ramat Gan, Israel, 52621
- Novartis Investigative Site
-
Tel Aviv, Israel, 6423906
- Novartis Investigative Site
-
-
-
-
-
Bologna, Italy, 40138
- Novartis Investigative Site
-
Novara, Italy, 28100
- Novartis Investigative Site
-
Padova, Italy, 35128
- Novartis Investigative Site
-
Pisa, Italy, 56126
- Novartis Investigative Site
-
-
VR
-
Verona, VR, Italy, 37126
- Novartis Investigative Site
-
-
-
-
Kagawa
-
Kita-gun, Kagawa, Japan, 761-0793
- Novartis Investigative Site
-
-
Osaka
-
Kawachinagano, Osaka, Japan, 586-8521
- Novartis Investigative Site
-
-
Tokyo
-
Bunkyo ku, Tokyo, Japan, 113-8431
- Novartis Investigative Site
-
Chuo ku, Tokyo, Japan, 104-8560
- Novartis Investigative Site
-
Meguro, Tokyo, Japan, 153-8515
- Novartis Investigative Site
-
Shinjuku ku, Tokyo, Japan, 162 8666
- Novartis Investigative Site
-
-
-
-
-
Seoul, Korea, Republic of, 03080
- Novartis Investigative Site
-
Seoul, Korea, Republic of, 06351
- Novartis Investigative Site
-
-
-
-
Coahuila
-
Torreon, Coahuila, Mexico, 27000
- Novartis Investigative Site
-
-
Estado De Mexico
-
Metepec, Estado De Mexico, Mexico, 52140
- Novartis Investigative Site
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico, 44160
- Novartis Investigative Site
-
-
MEX
-
Culiacan, MEX, Mexico, 80000
- Novartis Investigative Site
-
-
-
-
-
Amsterdam, Netherlands, 1105 AZ
- Novartis Investigative Site
-
Groningen, Netherlands, 9713 GZ
- Novartis Investigative Site
-
Maastricht, Netherlands, 6229 HX
- Novartis Investigative Site
-
-
-
-
-
Kongsvinger, Norway, 2212
- Novartis Investigative Site
-
Moss, Norway, 1538
- Novartis Investigative Site
-
-
-
-
-
Krakow, Poland, 30-510
- Novartis Investigative Site
-
Poznan, Poland, 60-218
- Novartis Investigative Site
-
Poznan, Poland, 61 113
- Novartis Investigative Site
-
Warszawa, Poland, 04 305
- Novartis Investigative Site
-
Warszawa, Poland, 02 118
- Novartis Investigative Site
-
Wroclaw, Poland, 53-224
- Novartis Investigative Site
-
-
-
-
-
Almada, Portugal, 2801 951
- Novartis Investigative Site
-
Braga, Portugal, 4710243
- Novartis Investigative Site
-
Lisboa, Portugal, 1050-034
- Novartis Investigative Site
-
Lisboa, Portugal, 1649-035
- Novartis Investigative Site
-
Ponte de Lima, Portugal, 4990 041
- Novartis Investigative Site
-
-
-
-
-
Barnaul, Russian Federation, 656024
- Novartis Investigative Site
-
Ekaterinburg, Russian Federation, 620028
- Novartis Investigative Site
-
Kemerovo, Russian Federation, 650000
- Novartis Investigative Site
-
Moscow, Russian Federation, 115522
- Novartis Investigative Site
-
Moscow, Russian Federation, 127473
- Novartis Investigative Site
-
Saint Petersburg, Russian Federation, 197022
- Novartis Investigative Site
-
Saratov, Russian Federation, 410053
- Novartis Investigative Site
-
Smolensk, Russian Federation, 214019
- Novartis Investigative Site
-
-
-
-
-
Madrid, Spain, 28041
- Novartis Investigative Site
-
Madrid, Spain, 28046
- Novartis Investigative Site
-
Madrid, Spain, 28009
- Novartis Investigative Site
-
-
Alicante
-
Elda, Alicante, Spain, 03600
- Novartis Investigative Site
-
-
Andalucia
-
Cordoba, Andalucia, Spain, 14004
- Novartis Investigative Site
-
Malaga, Andalucia, Spain, 29010
- Novartis Investigative Site
-
Sevilla, Andalucia, Spain, 41009
- Novartis Investigative Site
-
-
Barcelona
-
Hospitalet de Llobregat, Barcelona, Spain, 08907
- Novartis Investigative Site
-
Sabadell, Barcelona, Spain, 08208
- Novartis Investigative Site
-
-
Cantabria
-
Santander, Cantabria, Spain, 39008
- Novartis Investigative Site
-
-
Comunidad Valenciana
-
Valencia, Comunidad Valenciana, Spain, 46026
- Novartis Investigative Site
-
-
Galicia
-
La Coruna, Galicia, Spain, 15006
- Novartis Investigative Site
-
Santiago de Compostela, Galicia, Spain, 15706
- Novartis Investigative Site
-
-
Pais Vasco
-
Bilbao, Pais Vasco, Spain, 48013
- Novartis Investigative Site
-
-
Pontevedra
-
Vigo, Pontevedra, Spain, 36200
- Novartis Investigative Site
-
-
-
-
-
Goteborg, Sweden, SE-413 45
- Novartis Investigative Site
-
Lund, Sweden, 221 85
- Novartis Investigative Site
-
Uppsala, Sweden, 751 85
- Novartis Investigative Site
-
-
-
-
-
Basel, Switzerland, 4031
- Novartis Investigative Site
-
Fribourg, Switzerland, 1708
- Novartis Investigative Site
-
-
-
-
-
Ankara, Turkey, 06100
- Novartis Investigative Site
-
-
-
-
-
Bath, United Kingdom, BA1 3NG
- Novartis Investigative Site
-
Doncaster, United Kingdom, DN2 5LT
- Novartis Investigative Site
-
Middlesbrough, United Kingdom, TS4 3BW
- Novartis Investigative Site
-
Northampton, United Kingdom, NN1 5BD
- Novartis Investigative Site
-
Wolverhampton, United Kingdom, WV10 0QP
- Novartis Investigative Site
-
-
Essex
-
Westcliff-on-Sea, Essex, United Kingdom, SS0 0RY
- Novartis Investigative Site
-
-
London
-
Leytonstone, London, United Kingdom, E11 1NR
- Novartis Investigative Site
-
-
Staffordshire
-
Stoke on Trent, Staffordshire, United Kingdom, ST6 7AG
- Novartis Investigative Site
-
-
West Sussex
-
Worthing, West Sussex, United Kingdom, BN11 2DH
- Novartis Investigative Site
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35205
- Novartis Investigative Site
-
-
California
-
Beverly Hills, California, United States, 90211
- Novartis Investigative Site
-
Fullerton, California, United States, 92835
- Novartis Investigative Site
-
-
Colorado
-
Denver, Colorado, United States, 80230
- Novartis Investigative Site
-
-
Florida
-
Gainesville, Florida, United States, 32608
- Novartis Investigative Site
-
-
Idaho
-
Idaho Falls, Idaho, United States, 83404
- Novartis Investigative Site
-
-
Kentucky
-
Bowling Green, Kentucky, United States, 42101
- Novartis Investigative Site
-
-
Michigan
-
Lansing, Michigan, United States, 48910
- Novartis Investigative Site
-
-
Montana
-
Great Falls, Montana, United States, 59405
- Novartis Investigative Site
-
-
New York
-
Albany, New York, United States, 12206
- Novartis Investigative Site
-
Potsdam, New York, United States, 13676
- Novartis Investigative Site
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28204
- Novartis Investigative Site
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73102
- Novartis Investigative Site
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Novartis Investigative Site
-
-
Pennsylvania
-
Duncansville, Pennsylvania, United States, 16635
- Novartis Investigative Site
-
-
South Carolina
-
Charleston, South Carolina, United States, 29460
- Novartis Investigative Site
-
-
Texas
-
Leander, Texas, United States, 78641
- Novartis Investigative Site
-
Mesquite, Texas, United States, 75150
- Novartis Investigative Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Tumor Necrosis Factor (TNF) α inhibitor (not more than one) must have experienced an inadequate response
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Secukinumab, 150 mg Load (Core phase)
Secukinumab 150 mg s.c., pre-filled syringe (PFS) at baseline, Weeks 1, 2, and 3, followed by administration every four weeks starting at Week 4, Load, Core phase
|
Induction: 4x 150 mg Secukinumab s.c.
weekly Maintenance: 150 mg Secukinumab s.c.
monthly
Other Names:
|
EXPERIMENTAL: Secukinumab, 150 mg No Load (Core phase)
Secukinumab 150 mg s.c.
PFS at baseline, placebo at Weeks 1, 2, and 3, followed by secukinumab 150 mg PFS administration every four weeks starting at Week 4, No Load, Core phase
|
Induction: 4x 150 mg Secukinumab s.c.
weekly Maintenance: 150 mg Secukinumab s.c.
monthly
Other Names:
|
PLACEBO_COMPARATOR: Placebo (Core phase)
Placebo s.c., PFS at baseline, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4, Core phase
|
Induction: 4x placebo s.c.
weekly Maintenance: placebo s.c.
monthly
Other Names:
|
EXPERIMENTAL: Core Phase Responder 150 mg (Extension phase)
Core Phase Responder 150 mg blinded: secukinumab 150 mg s.c.
PFS and placebo (1 mL) s.c.
PFS every four weeks, in the Extension phase
|
Induction: 4x placebo s.c.
weekly Maintenance: placebo s.c.
monthly
Other Names:
Induction: 4x 150 mg Secukinumab s.c.
weekly Maintenance: 150 mg Secukinumab s.c.
monthly
Other Names:
|
EXPERIMENTAL: Core Phase Responder 300 mg (Extension phase)
Core Phase Responder 300 mg blinded: 2 injections with secukinumab 150 mg s.c.
PFS every four weeks, in the Extension phase
|
Induction: 4x 150 mg Secukinumab s.c.
weekly Maintenance: 150 mg Secukinumab s.c.
monthly
Other Names:
|
EXPERIMENTAL: Core Phase Non-Responder 300 mg (Extension phase)
Core Phase Non-Responder 300 mg: 2 injections with secukinumab 150 mg s.c.
PFS every four weeks open-label, in the Extension phase
|
Induction: 4x 150 mg Secukinumab s.c.
weekly Maintenance: 150 mg Secukinumab s.c.
monthly
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response at Week 16
Time Frame: Week 16
|
Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). 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. A higher score on the VAS signifies higher severity. |
Week 16
|
The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 52
Time Frame: Week 52
|
Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). 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. A higher score on the VAS signifies higher severity. |
Week 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response
Time Frame: Week 16 and week 52
|
Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). 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. A higher score on the VAS signifies higher severity. |
Week 16 and week 52
|
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 20 Response
Time Frame: Week 16
|
Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). 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. A higher score on the VAS signifies higher severity. |
Week 16
|
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response
Time Frame: Week 16
|
Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains. A higher score on the VAS signifies higher severity. |
Week 16
|
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society Partial Remission (ASAS PR)
Time Frame: Week 16
|
Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). 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. A higher score on the VAS signifies higher severity. |
Week 16
|
Change in Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: Baseline and Week 16
|
The Bath Ankylosing Spondylitis Functional Index (BASFI) is a set of 10 questions designed to determine the degree of functional limitation in those subjects with AS.
The ten questions were chosen with a major input from subjects with AS.
The first 8 questions consider activities related to functional anatomy.
The final 2 questions assess the subjects' ability to cope with everyday life.
A 100 mm visual analog scale (VAS) is used to answer the questions.
The mean of the ten questions gives the BASFI score - a value between 0 and 10. (0 being no problem and 10 being the worst problem, captured as a continuous visual analog scale (VAS)).
A higher score on the VAS signifies higher severity.
|
Baseline and Week 16
|
The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
Time Frame: Week 16 and 52
|
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.
The BASDAI 50 is defined as an improvement of at least 50% in the BASDAI compared to baseline.
A higher score on the VAS signifies higher severity.
|
Week 16 and 52
|
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: Baseline and Week 16
|
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a validated assessment tool using 1 through 10 scales (1 indicating "no problem" and 10 indicating " worst problem"), to characterize six clinical domains (fatigue, spinal pain, joint pain/selling, localized tenderness, morning stiffness duration, morning stiffness severity) pertaining to five major symptoms of Ankylosing Spondylitis (AS).
The computed final BASDAI score is a value between 0 and 10 with a higher score indicating worse disease.
A higher score on the VAS signifies higher severity.
|
Baseline and Week 16
|
Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 16
Time Frame: Baseline and Week 16
|
The Ankylosing Spondylitis Quality of Life scores (ASQoL) is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis.
The ASQoL contains 18 items with a dichotomous yes/no response option.
A single point is assigned for each "yes" response and no points for each "no" response resulting in overall scores that range from 0 (least severity) to 18 (highest severity).
As such, lower score indicate better quality of life.
Items include an assessment of mobility/energy, self-care and mood/emotion.
The recall period is "at the moment," and the measure requires approximately 6 minutes to complete.
|
Baseline and Week 16
|
Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 52
Time Frame: Baseline and Week 52
|
The Ankylosing Spondylitis Quality of Life scores (ASQoL) is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each "yes" response and no points for each "no" response resulting in overall scores that range from 0 (least severity) to 18 (highest severity). As such, lower score indicate better quality of life. Items include an assessment of mobility/energy, self-care and mood/emotion. The recall period is "at the moment," and the measure requires approximately 6 minutes to complete. Summary statistics are presented for participants (n) without intercurrent events. |
Baseline and Week 52
|
The Number and Percentage of Patients Who Achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease
Time Frame: Week 52
|
Ankylosing Spondylitis Disease Activity Score (ASDAS) - C-reactive protein (CRP) inactive disease criteria are defined as a value below 1.3.
Higher score indicates worse symptoms.
The formula is: ASDAS-CRP = 0.121 x total back pain + 0.110 x patient global + 0.073 x peripheral pain/swelling + 0.058 x duration of morning stiffness + 0.579 x ln(hsCRP +1)
|
Week 52
|
Change in High Sensitivity C-reactive Protein
Time Frame: Baseline and Week 16
|
High sensitivity C-reactive protein is measured as a marker of inflammation from blood samples during the study.
|
Baseline and Week 16
|
Change in Short Form-36 Physical Component Summary (SF-36 PCS)
Time Frame: Baseline and Week 16
|
The Short Form-36 Physical Component Summary (SF-36 PCS) is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of eight subscales (domains) that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role- Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed. The eight domains are based on a scale from 0-100 while PCS and MCS are norm-based scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of functioning. A positive change from baseline score indicates an improvement. |
Baseline and Week 16
|
Change in Sacroiliac Joint Edema - Week 16
Time Frame: Baseline and Week 16
|
Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a maximum score of 24.
|
Baseline and Week 16
|
Change in Sacroiliac Joint Edema - Week 52
Time Frame: Baseline and Week 52
|
Magnetic Resonance Images (MRI) of the Sacroiliac Joint (SIJ) were assessed for the presence and severity of SIJ bone marrow edema according to the Berlin Active Inflammatory Lesions Scoring with a maximum score of 24.
|
Baseline and Week 52
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.
- Braun J, Blanco R, Marzo-Ortega H, Gensler LS, van den Bosch F, Hall S, Kameda H, Poddubnyy D, van de Sande M, Wiksten AS, Porter BO, Shete A, Richards HB, Haemmerle S, Deodhar A. Secukinumab in non-radiographic axial spondyloarthritis: subgroup analysis based on key baseline characteristics from a randomized phase III study, PREVENT. Arthritis Res Ther. 2021 Sep 4;23(1):231. doi: 10.1186/s13075-021-02613-9.
- Deodhar A, Blanco R, Dokoupilova E, Hall S, Kameda H, Kivitz AJ, Poddubnyy D, van de Sande M, Wiksten AS, Porter BO, Richards HB, Haemmerle S, Braun J. Improvement of Signs and Symptoms of Nonradiographic Axial Spondyloarthritis in Patients Treated With Secukinumab: Primary Results of a Randomized, Placebo-Controlled Phase III Study. Arthritis Rheumatol. 2021 Jan;73(1):110-120. doi: 10.1002/art.41477. Epub 2020 Nov 24.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAIN457H2315
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-radiographic Spondyloarthritis
-
Sunshine Guojian Pharmaceutical (Shanghai) Co.,...Not yet recruitingAxial SpondyloarthritisChina
-
Merck Sharp & Dohme LLCCompletedSpondyloarthritisCzechia, Germany, Netherlands, Poland, Romania, Russian Federation, Spain, Turkey, Ukraine
-
Novartis PharmaceuticalsActive, not recruitingNon-radiographic Axial SpondyloarthritisChina
-
Novartis PharmaceuticalsRecruitingNon-radiographic Axial SpondyloarthritisBelgium, Netherlands, Italy, Thailand, Hungary, Malaysia, Germany, Israel, France, Czechia, Colombia, Romania, Poland, Turkey, Vietnam, Brazil, Mexico, Philippines
-
Galapagos NVGilead SciencesCompletedRheumatoid Arthritis | Psoriatic Arthritis | Ankylosing Spondylitis | Non-Radiographical Axial SpondyloarthritisBulgaria, Ukraine, Poland, Estonia, Czechia, Georgia, Latvia, Spain
-
Shanghai Junshi Bioscience Co., Ltd.Sponsor GmbHRecruitingNon-radiographic Axial SpondyloarthritisChina
-
Jiangsu HengRui Medicine Co., Ltd.RecruitingNon-radiographic Axial SpondyloarthritisChina
-
University Hospital, Strasbourg, FranceUnknownNon-radiographic SpondyloarthritisFrance
-
UCB Biopharma SRLCompletedNonradiographic Axial SpondyloarthritisUnited States, Belgium, Bulgaria, China, Czechia, France, Germany, Hungary, Japan, Poland, Spain, Turkey, United Kingdom
-
Novartis PharmaceuticalsActive, not recruitingPsoriatic Arthritis | Ankylosing Spondylitis | Moderate to Severe Plaque Psoriasis | Non-radiographic Axial SpondyloarthritisThailand
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States