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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 7 October 2019
Main ID:  JPRN-JapicCTI-184106
Date of registration: 11/09/2018
Prospective Registration: Yes
Primary sponsor: Novartis Pharma K.K.
Public title: Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar) (SURPASS)
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
Date of first enrolment: 07/11/2018
Target sample size: 15
Recruitment status: complete
URL:  https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-184106
Study type:  INTERVENTIONAL
Study design:  Randomized, Parallel Assignment, Single (Outcomes Assessor) blind  
Phase:  3
Countries of recruitment
Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa
Contacts
Name: Novartis Pharma K. K. Novartis Direct   
Address: 
Telephone: 0120-003-293
Email:
Affiliation: 
Name: Novartis Pharma K. K. Novartis Direct   
Address:  0120-003-293
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
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

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 TNF-alpha
*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


Age minimum: 18
Age maximum:
Gender: BOTH
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
Intervention(s)
Intervention name : Secukinumab
INN of the intervention : Secukinumab
Dosage And administration of the intervention : Secukinumab 150mg or 300mg will be administered at Baseline, Weeks 1, 2, 3 and 4, followed by dosing every 4 weeks until Week 100
Control intervention name : GP2017 (adalimumab biosimilar)
INN of the control intervention : Adalimumab
Dosage And administration of the control intervention : GP2017 (adalimumab biosimilar) 40 mg will be administered at Baseline followed by dosing every 2 weeks until Week 102
Primary Outcome(s)
efficacy
No radiographic progression as measured by modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) [ Time Frame: 104 weeks ]
To demonstrate the proportion of subjects on secukinumab (combined 150 mg s.c. and 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.)
Secondary Outcome(s)
efficacy
No radiographic progression as measured by modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) [ Time Frame: 104 weeks ]
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.)
efficacy
Change from baseline in modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) [ Time Frame: 104 weeks ]
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
efficacy
No new syndesmophytes as measured by mSASSS [ Time Frame: 104 weeks ]
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
efficacy
Assessment of SpondyloArthritis International Society 20 (ASAS20) [ Time Frame: 104 weeks ]
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
efficacy
ASAS40 [ Time Frame: 104 weeks ]
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
efficacy
ASAS partial remission [ Time Frame: 104 weeks ]
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
efficacy
Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease [ Time Frame: 104 weeks ]
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.
efficacy
Berlin sacroiliac (SI) joint edema score [ Time Frame: 104 weeks ]
To evaluate the Berlin SI joint edema score in subjects on secukinumab (150 mg s.c. and 300 mg s.c.) at Week 104 versus GP2017 (adalimumab biosimilar 40 mg s.c.)
efficacy
Ankylosing Spondylitis Spine Magnetic Resonance Imaging - activity (ASspiMRI-a) Berlin modification score [ Time Frame: 104 weeks ]
To evaluate the ASspiMRI-a Berlin modification score in subjects on secukinumab (150 mg s.c. and 300 mg s.c.) at Week 104 versus GP2017 (adalimumab biosimilar 40 mg s.c.)
Secondary ID(s)
NCT03259074
Source(s) of Monetary Support
-
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date:
Contact:
im67@kochi-u.ac.jp
Kochi Medical School Hospital IRB
088-880-2627
im67@kochi-u.ac.jp
Results
Results available:
Date Posted:
Date Completed:
URL:
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