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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02696031
Registration number
NCT02696031
Ethics application status
Date submitted
13/10/2015
Date registered
2/03/2016
Date last updated
29/04/2022
Titles & IDs
Public title
Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis
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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
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Secondary ID [1]
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CAIN457H2315
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Universal Trial Number (UTN)
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Trial acronym
PREVENT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-radiographic Spondyloarthritis
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Condition category
Condition code
Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Inflammatory and Immune System
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Rheumatoid arthritis
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Musculoskeletal
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Osteoarthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Secukinumab
Treatment: Drugs - Placebo
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
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
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
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
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
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
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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response at Week 16
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Assessment method [1]
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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.
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Timepoint [1]
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Week 16
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Primary outcome [2]
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The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 52
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Assessment method [2]
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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.
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Timepoint [2]
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Week 52
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Secondary outcome [1]
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The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response
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Assessment method [1]
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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.
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Timepoint [1]
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Week 16 and week 52
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Secondary outcome [2]
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The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 20 Response
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Assessment method [2]
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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.
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Timepoint [2]
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Week 16
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Secondary outcome [3]
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The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response
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Assessment method [3]
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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.
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Timepoint [3]
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Week 16
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Secondary outcome [4]
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The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society Partial Remission (ASAS PR)
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Assessment method [4]
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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.
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Timepoint [4]
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Week 16
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Secondary outcome [5]
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Change in Bath Ankylosing Spondylitis Functional Index (BASFI)
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline and Week 16
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Secondary outcome [6]
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The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
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Assessment method [6]
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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.
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Timepoint [6]
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Week 16 and 52
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Secondary outcome [7]
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Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline and Week 16
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Secondary outcome [8]
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Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 16
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline and Week 16
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Secondary outcome [9]
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Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 52
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline and Week 52
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Secondary outcome [10]
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The Number and Percentage of Patients Who Achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease
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Assessment method [10]
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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)
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Timepoint [10]
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Week 52
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Secondary outcome [11]
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Change in High Sensitivity C-reactive Protein
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Assessment method [11]
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High sensitivity C-reactive protein is measured as a marker of inflammation from blood samples during the study.
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Timepoint [11]
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Baseline and Week 16
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Secondary outcome [12]
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Change in Short Form-36 Physical Component Summary (SF-36 PCS)
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline and Week 16
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Secondary outcome [13]
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Change in Sacroiliac Joint Edema - Week 16
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline and Week 16
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Secondary outcome [14]
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Change in Sacroiliac Joint Edema - Week 52
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Assessment method [14]
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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.
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Timepoint [14]
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Baseline and Week 52
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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 Tumor Necrosis Factor (TNF) a inhibitor (not more than
one) must have experienced an inadequate response
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/04/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
11/03/2021
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Sample size
Target
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Accrual to date
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Final
555
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Coffs Harbour
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Recruitment hospital [2]
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Novartis Investigative Site - Maroochydore
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Recruitment hospital [3]
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Novartis Investigative Site - Hobart
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Recruitment hospital [4]
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Novartis Investigative Site - Malvern East
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Recruitment hospital [5]
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Novartis Investigative Site - Woolloongabba
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Recruitment postcode(s) [1]
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2450 - Coffs Harbour
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Recruitment postcode(s) [2]
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4558 - Maroochydore
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Recruitment postcode(s) [3]
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7000 - Hobart
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Recruitment postcode(s) [4]
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3145 - Malvern East
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Recruitment postcode(s) [5]
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QLD 4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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California
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Colorado
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Florida
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Idaho
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Kentucky
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United States of America
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Michigan
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United States of America
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Montana
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United States of America
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New York
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United States of America
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North Carolina
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Oklahoma
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Oregon
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Texas
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Austria
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Graz
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Austria
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Vienna
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Belgium
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Bruxelles
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Belgium
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Genk
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Belgium
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Gent
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Czechia
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Czech Republic
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Czechia
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CZE
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Czechia
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CZ
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Czechia
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Uherske Hradiste
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France
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Haute Vienne
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France
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Bordeaux Cedex
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France
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Boulogne Billancourt
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France
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Chambray les Tours
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France
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Monaco
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France
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Paris Cedex 14
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France
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Poitiers
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France
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Rouen Cedex
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Germany
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Niedersachsen
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Germany
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Berlin
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Germany
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Cottbus
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Germany
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Dresden
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Germany
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Erlangen
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Herne
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Germany
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Magdeburg
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Germany
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Potsdam
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Eger
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Hungary
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Szeged
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Hungary
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Szekesfehervar
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0
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Hungary
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Veszprem
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Israel
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Haifa
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Israel
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Kfar Saba
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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VR
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Italy
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Bologna
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Italy
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Novara
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Italy
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Padova
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Italy
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Pisa
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Kagawa
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Japan
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Osaka
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Japan
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Seoul
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Mexico
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Coahuila
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Mexico
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Mexico
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Jalisco
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Mexico
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MEX
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Netherlands
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Amsterdam
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Netherlands
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Groningen
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Netherlands
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Maastricht
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Norway
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Kongsvinger
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Norway
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Moss
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Poland
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Krakow
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Poland
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Poznan
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Poland
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Warszawa
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Poland
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Wroclaw
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Portugal
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Almada
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Portugal
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Braga
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Portugal
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Lisboa
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Portugal
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Ponte de Lima
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Russian Federation
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Barnaul
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kemerovo
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Smolensk
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Spain
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Alicante
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Spain
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Andalucia
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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Comunidad Valenciana
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Spain
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Galicia
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Country [94]
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Spain
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Pais Vasco
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Spain
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Pontevedra
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Spain
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Madrid
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Sweden
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Goteborg
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Country [98]
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Sweden
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Lund
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Sweden
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Uppsala
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Switzerland
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Basel
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Switzerland
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Fribourg
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Turkey
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Ankara
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United Kingdom
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Essex
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United Kingdom
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London
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United Kingdom
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Staffordshire
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United Kingdom
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West Sussex
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United Kingdom
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Bath
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United Kingdom
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Doncaster
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Country [109]
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United Kingdom
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Middlesbrough
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United Kingdom
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Northampton
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Country [111]
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United Kingdom
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Wolverhampton
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Funding & Sponsors
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Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Summary
Brief summary
The purpose of this study was 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 (core phase) followed by an optional
extension phase consisting of a 16-week randomized dose escalation treatment period and a
continuous treatment period for up to Week 208
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02696031
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Contacts
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02696031
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