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NCT03259074 Clinical Trial

Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)

Ankylosing Spondylitis Clinical Trial

— SURPASS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03259074
Other study ID # CAIN457K2340
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 30, 2017
Est. completion date November 29, 2021

Study information
Verified date August 2023
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Description:

This was a Phase IIIb, multi-center, randomized, partially-blinded, active-controlled, parallel-group design in subjects with AS. The study consisted of a screening period (up to 10 weeks before randomization), a treatment period (104 weeks), and two follow-up visits (Weeks 112 and 120). Subjects in both secukinumab dose groups received study treatment at baseline, Weeks 1, 2, 3 and 4 followed by treatment every 4 weeks through Week 100. Subjects in the GP2017 group received study treatment at baseline and every two weeks through Week 102. Subjects could self-administer all secukinumab / placebo and GP2017 doses at the study site or at home. Study treatment (secukinumab vs. GP2017) was provided in an open-label fashion. Subjects in the secukinumab groups were blinded to the dose (150 mg vs. 300 mg). Subjects who received rescue treatment with prohibited medications were allowed to remain in the study but had to discontinue study treatment. Subjects were treated for 104 weeks with two follow-up visits (Weeks 112 and 120). A total of 859 subjects were randomized to treatment at 171 sites in 30 countries in Europe, North America, South America, and Asia. .

Recruitment information / eligibility
Status Completed
Enrollment 859
Est. completion date November 29, 2021
Est. primary completion date November 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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

Related Conditions & MeSH terms

Intervention

Biological:
• Placebo
Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes
• GP2017 (adalimumab biosimilar)
40 mg in pre-filled syringes was administered subcutaneously
• AIN457 150 mg
150 mg in pre-filled syringes was administered subcutaneously

Locations
Country Name City State
Argentina Novartis Investigative Site Ciudad Autonoma de Bs As
Australia Novartis Investigative Site Malvern East Victoria
Belgium Novartis Investigative Site Bruxelles
Belgium Novartis Investigative Site Genk
Canada Novartis Investigative Site Barrie Ontario
Canada Novartis Investigative Site Quebec
Canada Novartis Investigative Site Trois Rivieres Quebec
Canada Novartis Investigative Site Winnipeg Manitoba
Chile Novartis Investigative Site Concepcion
Chile Novartis Investigative Site Santiago
Chile Novartis Investigative Site Santiago
Chile Novartis Investigative Site Santiago RM
Colombia Novartis Investigative Site Barranquilla
Colombia Novartis Investigative Site Bucaramanga Santander
Czechia Novartis Investigative Site Brno
Czechia Novartis Investigative Site Brno-Zidonice CZE
Czechia Novartis Investigative Site Praha 11
Czechia Novartis Investigative Site Praha 2
Czechia Novartis Investigative Site Uherske Hradiste
Denmark Novartis Investigative Site Aalborg
Denmark Novartis Investigative Site Copenhagen
Finland Novartis Investigative Site Joensuu
France Novartis Investigative Site Boulogne Billancourt
France Novartis Investigative Site Le Mans
France Novartis Investigative Site Monaco
France Novartis Investigative Site Nice Cedex1
France Novartis Investigative Site Paris
France Novartis Investigative Site Paris Cedex 14
France Novartis Investigative Site Toulouse
Germany Novartis Investigative Site Bad Doberan
Germany Novartis Investigative Site Bayreuth
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Chemnitz
Germany Novartis Investigative Site Erlangen
Germany Novartis Investigative Site Gottingen
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Herne
Germany Novartis Investigative Site Magdeburg
Germany Novartis Investigative Site Planegg
Germany Novartis Investigative Site Ratingen
Greece Novartis Investigative Site Athens
Greece Novartis Investigative Site Athens
Greece Novartis Investigative Site Thessaloniki GR
Israel Novartis Investigative Site Haifa
Israel Novartis Investigative Site Haifa
Israel Novartis Investigative Site Tel Aviv
Japan Novartis Investigative Site Bunkyo ku Tokyo
Japan Novartis Investigative Site Chuo ku Tokyo
Japan Novartis Investigative Site Kita-gun Kagawa
Japan Novartis Investigative Site Meguro Tokyo
Japan Novartis Investigative Site Nankoku city Kochi
Japan Novartis Investigative Site Nishinomiya Hyogo
Japan Novartis Investigative Site Shinjuku-ku Tokyo
Japan Novartis Investigative Site Tenri Nara
Korea, Republic of Novartis Investigative Site Gwangju
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul
Korea, Republic of Novartis Investigative Site Seoul Seocho Gu
Mexico Novartis Investigative Site Culiacan MEX
Mexico Novartis Investigative Site Mexicali Baja California
Mexico Novartis Investigative Site Monterrey Nuevo Leon
Mexico Novartis Investigative Site San Luis potosi
Mexico Novartis Investigative Site Torreon Coahulia
Netherlands Novartis Investigative Site Amsterdam
Netherlands Novartis Investigative Site Leeuwarden
Netherlands Novartis Investigative Site Leiden Zuid-Holland
Netherlands Novartis Investigative Site Maastricht
Netherlands Novartis Investigative Site Rotterdam
Peru Novartis Investigative Site Jesus Maria Lima
Peru Novartis Investigative Site Lima
Peru Novartis Investigative Site San Isidro Lima
Peru Novartis Investigative Site Santiago de Surco Lima
Philippines Novartis Investigative Site Manila
Philippines Novartis Investigative Site Quezon City
Philippines Novartis Investigative Site Quezon City
Poland Novartis Investigative Site Bydgoszcz
Poland Novartis Investigative Site Dopiewo
Poland Novartis Investigative Site Krakow
Poland Novartis Investigative Site Poznan
Poland Novartis Investigative Site Sopot
Portugal Novartis Investigative Site Almada
Portugal Novartis Investigative Site Lisboa
Portugal Novartis Investigative Site Lisboa
Portugal Novartis Investigative Site Ponte de Lima
Portugal Novartis Investigative Site Porto
Portugal Novartis Investigative Site Vila Nova de Gaia
Romania Novartis Investigative Site Bucharest
Romania Novartis Investigative Site Bucuresti
Romania Novartis Investigative Site Cluj Napoca
Russian Federation Novartis Investigative Site Barnaul
Russian Federation Novartis Investigative Site Chelyabinsk
Russian Federation Novartis Investigative Site Ekaterinburg
Russian Federation Novartis Investigative Site Ivanovo
Russian Federation Novartis Investigative Site Kazan
Russian Federation Novartis Investigative Site Kemerovo
Russian Federation Novartis Investigative Site Kemerovo
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Petrozavodsk
Russian Federation Novartis Investigative Site Saint Petersburg
Russian Federation Novartis Investigative Site Saint Petersburg
Russian Federation Novartis Investigative Site St Petersburg
Russian Federation Novartis Investigative Site Ufa
Russian Federation Novartis Investigative Site Yaroslavl
Slovakia Novartis Investigative Site Bratislava Slovak Republic
Slovakia Novartis Investigative Site Bratislava
Slovakia Novartis Investigative Site Kosice
Slovakia Novartis Investigative Site Piestany SVK
Slovakia Novartis Investigative Site Stara Lubovna
Spain Novartis Investigative Site Badalona Catalunya
Spain Novartis Investigative Site Barcelona Catalunya
Spain Novartis Investigative Site Bilbao Pais Vasco
Spain Novartis Investigative Site La Coruna Galicia
Spain Novartis Investigative Site Madrid
Spain Novartis Investigative Site San Vicente De Barakaldo Bizkaia
Spain Novartis Investigative Site Santander Cantabria
Spain Novartis Investigative Site Santiago de Compostela Galicia
Spain Novartis Investigative Site Valencia
Spain Novartis Investigative Site Vigo Pontevedra
Spain Novartis Investigative Site Villajoyosa Alicante
Spain Novartis Investigative Site Vitoria Vitoria Gasteiz
Taiwan Novartis Investigative Site Dalin
Taiwan Novartis Investigative Site Kaohsiung
Taiwan Novartis Investigative Site Kaohsiung
Taiwan Novartis Investigative Site Taichung Taiwan ROC
Taiwan Novartis Investigative Site Taipei
Turkey Novartis Investigative Site Ankara
Turkey Novartis Investigative Site Ankara
Turkey Novartis Investigative Site Eskisehir
Turkey Novartis Investigative Site Istanbul TUR
Turkey Novartis Investigative Site Izmir
Turkey Novartis Investigative Site Kocaeli
United Kingdom Novartis Investigative Site Bath
United Kingdom Novartis Investigative Site Bristol
United Kingdom Novartis Investigative Site Christchurch Dorset
United Kingdom Novartis Investigative Site Leicester
United Kingdom Novartis Investigative Site Leytonstone London
United Kingdom Novartis Investigative Site Liverpool
United Kingdom Novartis Investigative Site London
United Kingdom Novartis Investigative Site London Edmonton
United Kingdom Novartis Investigative Site London GBR
United Kingdom Novartis Investigative Site Norwich
United Kingdom Novartis Investigative Site Portsmouth Hants
United Kingdom Novartis Investigative Site Stoke on Trent Staffordshire
United Kingdom Novartis Investigative Site Torquay
United Kingdom Novartis Investigative Site Wolverhampton
United States Novartis Investigative Site Boise Idaho
United States Novartis Investigative Site Dayton Ohio
United States Novartis Investigative Site Duncansville Pennsylvania
United States Novartis Investigative Site Escondido California
United States Novartis Investigative Site Franklin Wisconsin
United States Novartis Investigative Site Gainesville Florida
United States Novartis Investigative Site Great Falls Montana
United States Novartis Investigative Site Greensboro North Carolina
United States Novartis Investigative Site Kennewick Washington
United States Novartis Investigative Site La Mesa California
United States Novartis Investigative Site Lincoln Nebraska
United States Novartis Investigative Site Memphis Tennessee
United States Novartis Investigative Site Mesa Arizona
United States Novartis Investigative Site Mesquite Texas
United States Novartis Investigative Site Middleburg Heights Ohio
United States Novartis Investigative Site Portland Oregon
United States Novartis Investigative Site San Francisco California
United States Novartis Investigative Site Shreveport Louisiana
United States Novartis Investigative Site Wheaton Maryland

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Canada,  Chile,  Colombia,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Israel,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Peru,  Philippines,  Poland,  Portugal,  Romania,  Russian Federation,  Slovakia,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set) 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. Baseline and at Week 104
Secondary Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set) 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.		 Baseline and at Week 104
Secondary Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset) 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). Baseline and at Week 104
Secondary Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset) 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. Baseline and at Week 104
Secondary Change From Baseline in Berlin Modification of ASspiMRI-a Edema Score (MRI Subset) 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. Baseline and at Week 104
Secondary Percentage of Responders for Assessment of SpondyloArthritis International Society 20 (ASAS20) 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. Week 104
Secondary Percentage of Responders for Assessment of SpondyloArthritis International Society 40 (ASAS 40) 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. Week 104
Secondary Percentage of Responders for Assessment of SpondyloArthritis International Society With a Partial Remission Response (Full Analysis Set) 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. Week 104
Secondary Percentage of Participants With Assessment of SpondyloArthritis International Society for Inactive Disease Response (Observed Data) (Full Analysis Set) 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). Week 104
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