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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03259074




Registration number
NCT03259074
Ethics application status
Date submitted
21/08/2017
Date registered
23/08/2017
Date last updated
12/03/2020

Titles & IDs
Public title
Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)
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
Secondary ID [1] 0 0
CAIN457K2340
Universal Trial Number (UTN)
Trial acronym
SURPASS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankylosing Spondylitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Secukinumab
Other interventions - GP2017 (adalimumab biosimilar)

Experimental: Secukinumab 150 mg s.c. - Secukinumab 150 mg will be administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100

Experimental: Secukinumab 300 mg s.c. - Secukinumab 300 mg will be administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100

Experimental: GP2017 (adalimumab biosimilar) 40mg s.c. - GP2017 (adalimumab biosimilar) 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 102


Other interventions: Secukinumab
Eligible subjects are randomized to one of three treatment arms in a 1:1:1 ratio

Other interventions: GP2017 (adalimumab biosimilar)
Eligible subjects are randomized to one of three treatment arms in a 1:1:1 ratio

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
No radiographic progression as measured by modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) - To demonstrate the proportion of subjects on secukinumab (150 mg s.c. or 300 mg s.c.) with no radiographic progression as measured by mSASSS at Week 104 is superior to subjects on GP2017 (adalimumab biosimilar 40 mg s.c.)
Timepoint [1] 0 0
104 weeks
Secondary outcome [1] 0 0
Change from baseline in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) - To demonstrate the change from baseline in mSASSS in subjects on secukinumab (150 mg s.c. or 300 mg s.c.) is superior to GP2017 (adalimumab biosimilar 40 mg s.c.) at Week 104
Timepoint [1] 0 0
104 weeks
Secondary outcome [2] 0 0
No new syndesmophytes as measured by mSASSS - The proportion of subjects with no new syndesmophytes is defined as the number of patients with a syndesmophyte at baseline who develops one by week 104, as measured by mSASSS
Timepoint [2] 0 0
104 weeks
Secondary outcome [3] 0 0
Assessment of SpondyloArthritis International Society 20 (ASAS20) - ASAS20 response is defined as an improvement of =20% and =1 unit on a scale of 10 in at least three of the four ASAS main domains and no worsening of =20% and =1 unit in the remaining domain
Timepoint [3] 0 0
104 weeks
Secondary outcome [4] 0 0
ASAS40 - ASAS40 response is defined as an improvement of =40% and =2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain
Timepoint [4] 0 0
104 weeks
Secondary outcome [5] 0 0
ASAS partial remission - ASAS partial remission is defined as a value not above 2 units in each of four main domains on a scale of 0 to 10
Timepoint [5] 0 0
104 weeks
Secondary outcome [6] 0 0
Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease - An ASDAS inactive disease response is a score of <1.3 on a composite index to assess disease activity in Ankylosing Spondylitis. Parameters include spinal pain, the patient's global assessment of disease activity, peripheral pain/swelling, duration of morning stiffness and C-reactive protein (CRP) in mg/L.
Timepoint [6] 0 0
104 weeks
Secondary outcome [7] 0 0
Berlin sacroiliac (SI) joint edema score - To evaluate the Berlin SI joint edema score in subjects on secukinumab (150 mg s.c. or 300 mg s.c.) at Week 104 versus GP2017 (adalimumab biosimilar 40 mg s.c.)
Timepoint [7] 0 0
104 weeks
Secondary outcome [8] 0 0
Ankylosing Spondylitis Spine Magnetic Resonance Imaging - activity (ASspiMRI-a) Berlin modification score - To evaluate the ASspiMRI-a Berlin modification score in subjects on secukinumab (150 mg s.c. or 300 mg s.c.) at Week 104 versus GP2017 (adalimumab biosimilar 40 mg s.c.)
Timepoint [8] 0 0
104 weeks

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Malvern East
Recruitment postcode(s) [1] 0 0
3145 - Malvern East
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to demonstrate the impact of secukinumab on progression of
structural damage in the spine, as measured by the mSASSS in patients with AS.
Trial website
https://clinicaltrials.gov/show/NCT03259074
Trial related presentations / publications
Public notes

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

Summary results
Other publications