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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/NCT03259074
Registration number
NCT03259074
Ethics application status
Date submitted
21/08/2017
Date registered
23/08/2017
Date last updated
21/08/2023
Titles & IDs
Public title
Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)
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Scientific title
A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis
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Secondary ID [1]
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CAIN457K2340
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Universal Trial Number (UTN)
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Trial acronym
SURPASS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ankylosing Spondylitis
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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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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Placebo
Other interventions - GP2017 (adalimumab biosimilar)
Other interventions - AIN457 150 mg
Experimental: AIN457 150 mg/placebo - AIN457 150 mg and a matching placebo was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100
Experimental: AIN457 300 mg - AIN457 300 mg (2 x 150 mg) was administered subcutaneously via pre-filled syringes at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100
Active Comparator: GP2017 40mg - GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 102
Other interventions: Placebo
Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes
Other interventions: GP2017 (adalimumab biosimilar)
40 mg in pre-filled syringes was administered subcutaneously
Other interventions: AIN457 150 mg
150 mg in pre-filled syringes was administered subcutaneously
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Intervention code [1]
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Other interventions
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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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Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set)
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Assessment method [1]
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Radiographic progression was based on scores from the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. No radiographic progression was defined as the change from baseline in mSASSS score <= 0.5.
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Timepoint [1]
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Baseline and at Week 104
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Secondary outcome [1]
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Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set)
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Assessment method [1]
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Radiographic changes in the spine were based on the change in score of the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) from baseline to Week 104.
The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72.
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Timepoint [1]
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Baseline and at Week 104
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Secondary outcome [2]
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Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset)
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Assessment method [2]
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Syndesmophytes are bony growths that develop on corner of the vertebrae of the spine which are indicators of AS. A participant was considered to have a syndesmophyte if at least one reader assessed vertebral corner as >= 2 at on the mSASSS scale at baseline. Only participants with a syndesmophyte at baseline were evaluated at Week 104 for new syndesmophytes. A new syndesmophyte was a syndesmophyte present at Week 104 which was not present at baseline. Absence of new syndesmophyte was defined as having individual vertebral score < 2 on the mSASSS scale for all interpretable locations that had no syndesmophyte at baseline. Missing responses for subjects without new syndesmophyte at Week 104 were imputed by multiple imputation (MCMC).
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Timepoint [2]
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Baseline and at Week 104
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Secondary outcome [3]
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Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset)
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Assessment method [3]
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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 minimum score of 0 and a maximum score of 24. Higher scores indicate more inflammation.
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Timepoint [3]
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Baseline and at Week 104
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Secondary outcome [4]
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Change From Baseline in Berlin Modification of ASspiMRI-a Edema Score (MRI Subset)
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Assessment method [4]
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Magnetic Resonance Images (MRI) of the spine were assessed for the presence and severity of bone marrow edema in the spinal vertebrae according to the Berlin modification of the ASspiMRI-a edema score with a score range of 0 to 69. Higher scores indicate more inflammation.
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Timepoint [4]
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Baseline and at Week 104
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Secondary outcome [5]
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Percentage of Responders for Assessment of SpondyloArthritis International Society 20 (ASAS20)
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Assessment method [5]
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Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). 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 [5]
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Week 104
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Secondary outcome [6]
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Percentage of Responders for Assessment of SpondyloArthritis International Society 40 (ASAS 40)
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Assessment method [6]
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Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 4 domains measured on visual analog scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). 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 [6]
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Week 104
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Secondary outcome [7]
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Percentage of Responders for Assessment of SpondyloArthritis International Society With a Partial Remission Response (Full Analysis Set)
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Assessment method [7]
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The Assessment of SpondyloArthritis International Society (ASAS) partial remission response criteria consisted of the following assessment domains measured on visual analogue scales (VAS): 1. Patient's global assessment; 2. Patient's assessment of back pain; 3. Function represented by BASFI average of 10 questions regarding ability to perform specific tasks; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The ASAS partial remission criteria was defined as a value not above 2 units in each of the four domains on a scale of 10.
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Timepoint [7]
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Week 104
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Secondary outcome [8]
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Percentage of Participants With Assessment of SpondyloArthritis International Society for Inactive Disease Response (Observed Data) (Full Analysis Set)
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Assessment method [8]
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The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a composite index to assess disease activity in AS. Parameters used for the ASDAS include spinal pain (BASDAI question 2), the patient's global assessment of disease activity, peripheral pain/swelling (BASDAI question 3), duration of morning stiffness (BASDAI question 6) and C-reactive protein (CRP) in mg/L (Sieper 2009, Lukas 2009). Disease activity states are inactive disease, moderate disease activity, high disease activity, and very high disease activity. The 3 values selected to separate these states were < 1.3 between inactive disease and moderate disease activity, < 2.1 between moderate disease activity and high disease activity, and > 3.5 between high disease activity and very high disease activity. Selected cutoffs for improvement scores were a change = 1.1 unit for "minimal clinically important improvement" and a change = 2.0 units for "major improvement" (Machado 2011).
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Timepoint [8]
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Week 104
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Eligibility
Key inclusion criteria
- Male or non-pregnant, non-nursing female patients at least 18 years of age
- Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence
(centrally read X-ray) fulfilling the Modified New York criteria for AS despite
previous or current NSAID/ nonbiologic DMARD therapy
- Active AS assessed by total BASDAI = 4 on a scale of 0-10
- Spinal pain as measured by BASDAI question #2 = 4 (0-10)
- Total back pain as measured by visual analog scale (VAS) = 40 mm (0-100 mm)
- hsCRP = 5 mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray
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Minimum age
18
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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 total ankylosis of the spine
- Pregnant or nursing (lactating) women
- Evidence of ongoing infectious or malignant process
- Previous exposure to any biologic immunomodulating agent, including those targeting
IL-17, IL-17 receptor or TNFa
- Subjects taking high potency opioid analgesics
- Previous treatment with any cell-depleting therapies including but not limited to
anti-CD20, investigational agents
Other protocol-defined inclusion/exclusion criteria may apply
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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 assessing the outcomes
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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
30/11/2017
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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
29/11/2021
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Sample size
Target
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Accrual to date
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Final
859
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Malvern East
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Recruitment postcode(s) [1]
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3145 - Malvern East
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Recruitment outside Australia
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Ciudad Autonoma de Bs As
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St Petersburg
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Russian Federation
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Ufa
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Russian Federation
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Kosice
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Slovakia
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Stara Lubovna
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Spain
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Alicante
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Spain
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Bizkaia
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Catalunya
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Galicia
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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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Vitoria Gasteiz
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Madrid
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Spain
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Valencia
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Taiwan
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Taiwan ROC
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Taiwan
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Dalin
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Taiwan
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Kaohsiung
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Taiwan
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Taipei
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Turkey
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TUR
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Turkey
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Ankara
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Turkey
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Eskisehir
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Turkey
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Izmir
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Turkey
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Kocaeli
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United Kingdom
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Dorset
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United Kingdom
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Edmonton
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United Kingdom
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GBR
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United Kingdom
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Hants
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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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Bath
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United Kingdom
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Bristol
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United Kingdom
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Leicester
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United Kingdom
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Norwich
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United Kingdom
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Torquay
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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 is to demonstrate the impact of secukinumab on the progression of
structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis
Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03259074
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Contacts
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03259074
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