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

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

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).

Study Overview

• Status: Completed
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Biological: Placebo; Biological: AIN457 150 mg; Biological: GP2017 (adalimumab biosimilar)

Detailed 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.

.

• Study Type: Interventional
• Enrollment (Actual): 859
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma de Bs As, Argentina, C1428AZF
    • Novartis Investigative Site
• Australia
  • Victoria
    • Malvern East, Victoria, Australia, 3145
      • Novartis Investigative Site
• Belgium
  • Bruxelles, Belgium, 1070
    • Novartis Investigative Site
  • Genk, Belgium, 3600
    • Novartis Investigative Site
• Canada
  • Quebec, Canada, G1V 3M7
    • Novartis Investigative Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1M1
      • Novartis Investigative Site
  • Ontario
    • Barrie, Ontario, Canada, L4M 6L2
      • Novartis Investigative Site
  • Quebec
    • Trois Rivieres, Quebec, Canada, G8Z 1Y2
      • Novartis Investigative Site
• Chile
  • Concepcion, Chile
    • Novartis Investigative Site
  • Santiago, Chile
    • Novartis Investigative Site
  • Santiago, Chile, 8207257
    • Novartis Investigative Site
  • RM
    • Santiago, RM, Chile, 7500588
      • Novartis Investigative Site
• Colombia
  • Barranquilla, Colombia, 080020
    • Novartis Investigative Site
  • Santander
    • Bucaramanga, Santander, Colombia, 0001
      • Novartis Investigative Site
• Czechia
  • Brno, Czechia, 63800
    • Novartis Investigative Site
  • Praha 11, Czechia, 14900
    • Novartis Investigative Site
  • Praha 2, Czechia, 128 50
    • Novartis Investigative Site
  • Uherske Hradiste, Czechia, 686 01
    • Novartis Investigative Site
  • CZE
    • Brno-Zidonice, CZE, Czechia, 61500
      • Novartis Investigative Site
• Denmark
  • Aalborg, Denmark, DK 9000
    • Novartis Investigative Site
  • Copenhagen, Denmark, 2100
    • Novartis Investigative Site
• Finland
  • Joensuu, Finland, 80210
    • Novartis Investigative Site
• France
  • Boulogne Billancourt, France, 92104
    • Novartis Investigative Site
  • Le Mans, France, 72037
    • Novartis Investigative Site
  • Monaco, France, 98000
    • Novartis Investigative Site
  • Paris, France, 75012
    • Novartis Investigative Site
  • Paris Cedex 14, France, 75679
    • Novartis Investigative Site
  • Toulouse, France, 31059
    • Novartis Investigative Site
  • Cedex1
    • Nice, Cedex1, France, 06001
      • Novartis Investigative Site
• Germany
  • Bad Doberan, Germany, 18209
    • Novartis Investigative Site
  • Bayreuth, Germany, 95444
    • Novartis Investigative Site
  • Berlin, Germany, 13125
    • Novartis Investigative Site
  • Berlin, Germany, 13353
    • Novartis Investigative Site
  • Berlin, Germany, 12163
    • Novartis Investigative Site
  • Berlin, Germany, 14059
    • Novartis Investigative Site
  • Chemnitz, Germany, 09130
    • Novartis Investigative Site
  • Erlangen, Germany, 91056
    • Novartis Investigative Site
  • Gottingen, Germany, 37075
    • Novartis Investigative Site
  • Hamburg, Germany, 20095
    • Novartis Investigative Site
  • Hamburg, Germany, 22415
    • Novartis Investigative Site
  • Herne, Germany, 44649
    • Novartis Investigative Site
  • Magdeburg, Germany, 39110
    • Novartis Investigative Site
  • Planegg, Germany, 82152
    • Novartis Investigative Site
  • Ratingen, Germany, 40878
    • Novartis Investigative Site
• Greece
  • Athens, Greece, 115 27
    • Novartis Investigative Site
  • Athens, Greece, 145 61
    • Novartis Investigative Site
  • GR
    • Thessaloniki, GR, Greece, 564 29
      • Novartis Investigative Site
• Israel
  • Haifa, Israel, 3339419
    • Novartis Investigative Site
  • Haifa, Israel, 3109601
    • Novartis Investigative Site
  • Tel Aviv, Israel, 6423906
    • Novartis Investigative Site
• Japan
  • Hyogo
    • Nishinomiya, Hyogo, Japan, 663 8501
      • Novartis Investigative Site
  • Kagawa
    • Kita-gun, Kagawa, Japan, 761-0793
      • Novartis Investigative Site
  • Kochi
    • Nankoku city, Kochi, Japan, 783 8505
      • Novartis Investigative Site
  • Nara
    • Tenri, Nara, Japan, 632-8552
      • Novartis Investigative Site
  • Tokyo
    • Bunkyo ku, Tokyo, Japan, 113-8431
      • Novartis Investigative Site
    • Chuo ku, Tokyo, Japan, 104-8560
      • Novartis Investigative Site
    • Meguro, Tokyo, Japan, 153-8515
      • Novartis Investigative Site
    • Shinjuku-ku, Tokyo, Japan, 160 8582
      • Novartis Investigative Site
• Korea, Republic of
  • Gwangju, Korea, Republic of, 61469
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 03080
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 04763
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 05278
    • Novartis Investigative Site
  • Seoul, Korea, Republic of, 06273
    • Novartis Investigative Site
  • Seocho Gu
    • Seoul, Seocho Gu, Korea, Republic of, 06591
      • Novartis Investigative Site
• Mexico
  • San Luis potosi, Mexico, 78213
    • Novartis Investigative Site
  • Baja California
    • Mexicali, Baja California, Mexico, 21100
      • Novartis Investigative Site
  • Coahulia
    • Torreon, Coahulia, Mexico, 27000
      • Novartis Investigative Site
  • MEX
    • Culiacan, MEX, Mexico, 80000
      • Novartis Investigative Site
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Novartis Investigative Site
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Novartis Investigative Site
  • Leeuwarden, Netherlands, 8934 AD
    • Novartis Investigative Site
  • Maastricht, Netherlands, 6229 HX
    • Novartis Investigative Site
  • Rotterdam, Netherlands, 3079 DZ
    • Novartis Investigative Site
  • Zuid-Holland
    • Leiden, Zuid-Holland, Netherlands, 2333 ZA
      • Novartis Investigative Site
• Peru
  • Lima, Peru, 1
    • Novartis Investigative Site
  • Lima
    • Jesus Maria, Lima, Peru, 11
      • Novartis Investigative Site
    • San Isidro, Lima, Peru, 27
      • Novartis Investigative Site
    • Santiago de Surco, Lima, Peru, 33
      • Novartis Investigative Site
• Philippines
  • Manila, Philippines, 1008
    • Novartis Investigative Site
  • Quezon City, Philippines, 1102
    • Novartis Investigative Site
  • Quezon City, Philippines, 1118
    • Novartis Investigative Site
• Poland
  • Bydgoszcz, Poland, 85 168
    • Novartis Investigative Site
  • Dopiewo, Poland, 62 069
    • Novartis Investigative Site
  • Krakow, Poland, 30 002
    • Novartis Investigative Site
  • Poznan, Poland, 61 113
    • Novartis Investigative Site
  • Sopot, Poland, 81 756
    • Novartis Investigative Site
• Portugal
  • Almada, Portugal, 2801 951
    • Novartis Investigative Site
  • Lisboa, Portugal, 1050-034
    • Novartis Investigative Site
  • Lisboa, Portugal, 1349 019
    • Novartis Investigative Site
  • Ponte de Lima, Portugal, 4990 041
    • Novartis Investigative Site
  • Porto, Portugal, 4200 319
    • Novartis Investigative Site
  • Vila Nova de Gaia, Portugal, 4434 502
    • Novartis Investigative Site
• Romania
  • Bucharest, Romania, 030167
    • Novartis Investigative Site
  • Bucuresti, Romania, 011172
    • Novartis Investigative Site
  • Cluj Napoca, Romania, 400006
    • Novartis Investigative Site
• Russian Federation
  • Barnaul, Russian Federation, 656050
    • Novartis Investigative Site
  • Chelyabinsk, Russian Federation, 454076
    • Novartis Investigative Site
  • Ekaterinburg, Russian Federation, 620137
    • Novartis Investigative Site
  • Ivanovo, Russian Federation, 153005
    • Novartis Investigative Site
  • Kazan, Russian Federation, 420097
    • Novartis Investigative Site
  • Kemerovo, Russian Federation, 650029
    • Novartis Investigative Site
  • Kemerovo, Russian Federation, 650066
    • Novartis Investigative Site
  • Moscow, Russian Federation, 115522
    • Novartis Investigative Site
  • Moscow, Russian Federation, 129110
    • Novartis Investigative Site
  • Petrozavodsk, Russian Federation, 185019
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 197022
    • Novartis Investigative Site
  • Saint Petersburg, Russian Federation, 197341
    • Novartis Investigative Site
  • St Petersburg, Russian Federation, 190068
    • Novartis Investigative Site
  • Ufa, Russian Federation, 450005
    • Novartis Investigative Site
  • Yaroslavl, Russian Federation, 150003
    • Novartis Investigative Site
• Slovakia
  • Bratislava, Slovakia, 85101
    • Novartis Investigative Site
  • Kosice, Slovakia, 04011
    • Novartis Investigative Site
  • Stara Lubovna, Slovakia, 06401
    • Novartis Investigative Site
  • SVK
    • Piestany, SVK, Slovakia, 921 12
      • Novartis Investigative Site
  • Slovak Republic
    • Bratislava, Slovak Republic, Slovakia, 813 69
      • Novartis Investigative Site
• Spain
  • Madrid, Spain, 28942
    • Novartis Investigative Site
  • Valencia, Spain, 46009
    • Novartis Investigative Site
  • Alicante
    • Villajoyosa, Alicante, Spain, 703570
      • Novartis Investigative Site
  • Bizkaia
    • San Vicente De Barakaldo, Bizkaia, Spain, 48903
      • Novartis Investigative Site
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Novartis Investigative Site
  • Catalunya
    • Badalona, Catalunya, Spain, 08916
      • Novartis Investigative Site
    • Barcelona, Catalunya, Spain, 08003
      • Novartis Investigative Site
  • Galicia
    • La Coruna, Galicia, Spain, 15006
      • Novartis Investigative Site
    • Santiago de Compostela, Galicia, Spain, 15706
      • Novartis Investigative Site
  • Pais Vasco
    • Bilbao, Pais Vasco, Spain, 48013
      • Novartis Investigative Site
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36200
      • Novartis Investigative Site
  • Vitoria Gasteiz
    • Vitoria, Vitoria Gasteiz, Spain, 01009
      • Novartis Investigative Site
• Taiwan
  • Dalin, Taiwan, 622
    • Novartis Investigative Site
  • Kaohsiung, Taiwan, 80756
    • Novartis Investigative Site
  • Kaohsiung, Taiwan, 81346
    • Novartis Investigative Site
  • Taipei, Taiwan, 10048
    • Novartis Investigative Site
  • Taiwan ROC
    • Taichung, Taiwan ROC, Taiwan, 40201
      • Novartis Investigative Site
• Turkey
  • Ankara, Turkey, 06560
    • Novartis Investigative Site
  • Ankara, Turkey, 06230
    • Novartis Investigative Site
  • Eskisehir, Turkey, 26040
    • Novartis Investigative Site
  • Izmir, Turkey, 35340
    • Novartis Investigative Site
  • Kocaeli, Turkey, 41380
    • Novartis Investigative Site
  • TUR
    • Istanbul, TUR, Turkey, 34098
      • Novartis Investigative Site
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Novartis Investigative Site
  • Bristol, United Kingdom, BS1 3NU
    • Novartis Investigative Site
  • Leicester, United Kingdom, LE1 5WW
    • Novartis Investigative Site
  • Liverpool, United Kingdom, L9 7AL
    • Novartis Investigative Site
  • London, United Kingdom, NW3 2QG
    • Novartis Investigative Site
  • Norwich, United Kingdom, NR4 7UY
    • Novartis Investigative Site
  • Torquay, United Kingdom, TQ2 7AA
    • Novartis Investigative Site
  • Wolverhampton, United Kingdom, WV10 0QP
    • Novartis Investigative Site
  • Dorset
    • Christchurch, Dorset, United Kingdom, BH23 2JX
      • Novartis Investigative Site
  • Edmonton
    • London, Edmonton, United Kingdom, N18 1QX
      • Novartis Investigative Site
  • GBR
    • London, GBR, United Kingdom, SW10 9NH
      • Novartis Investigative Site
  • Hants
    • Portsmouth, Hants, United Kingdom, PO6 3LY
      • Novartis Investigative Site
  • London
    • Leytonstone, London, United Kingdom, E11 1NR
      • Novartis Investigative Site
  • Staffordshire
    • Stoke on Trent, Staffordshire, United Kingdom, ST6 7AG
      • Novartis Investigative Site
• United States
  • Arizona
    • Mesa, Arizona, United States, 85202
      • Novartis Investigative Site
  • California
    • Escondido, California, United States, 92025
      • Novartis Investigative Site
    • La Mesa, California, United States, 91942
      • Novartis Investigative Site
    • San Francisco, California, United States, 94143 0138
      • Novartis Investigative Site
  • Florida
    • Gainesville, Florida, United States, 32607
      • Novartis Investigative Site
  • Idaho
    • Boise, Idaho, United States, 83702
      • Novartis Investigative Site
  • Louisiana
    • Shreveport, Louisiana, United States, 71101
      • Novartis Investigative Site
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • Novartis Investigative Site
  • Montana
    • Great Falls, Montana, United States, 59405
      • Novartis Investigative Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68516
      • Novartis Investigative Site
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • Novartis Investigative Site
  • Ohio
    • Dayton, Ohio, United States, 45402
      • Novartis Investigative Site
    • Middleburg Heights, Ohio, United States, 44130
      • Novartis Investigative Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • Novartis Investigative Site
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Novartis Investigative Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Novartis Investigative Site
  • Texas
    • Mesquite, Texas, United States, 75150
      • Novartis Investigative Site
  • Washington
    • Kennewick, Washington, United States, 99336
      • Novartis Investigative Site
  • Wisconsin
    • Franklin, Wisconsin, United States, 53132
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 TNFα
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Biological: Placebo; Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes; Biological: AIN457 150 mg; 150 mg in pre-filled syringes was administered subcutaneously; Other Names: secukinumab
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	Biological: AIN457 150 mg; 150 mg in pre-filled syringes was administered subcutaneously; Other Names: secukinumab
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	Biological: GP2017 (adalimumab biosimilar); 40 mg in pre-filled syringes was administered subcutaneously; Other Names: adalimumab biosimilar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Sieper J, Poddubnyy D. Twenty years of clinical trials in axial spondyloarthritis: what can we learn for the future? Curr Opin Rheumatol. 2021 Jul 1;33(4):363-369. doi: 10.1097/BOR.0000000000000804.
• Baraliakos X, Ostergaard M, Gensler LS, Poddubnyy D, Lee EY, Kiltz U, Martin R, Sawata H, Readie A, Porter B; SURPASS Study Group. Comparison of the Effects of Secukinumab and Adalimumab Biosimilar on Radiographic Progression in Patients with Ankylosing Spondylitis: Design of a Randomized, Phase IIIb Study (SURPASS). Clin Drug Investig. 2020 Mar;40(3):269-278. doi: 10.1007/s40261-020-00886-7.

Helpful Links

• A Plain Language Trial Summary is available on novctrd.com

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Actual): November 12, 2021
• Study Completion (Actual): November 29, 2021

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (Actual): August 23, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: adult; ankylosing spondylitis; AIN457; AS; secukinumab; GP2017; radiographic; mSASSS; r-axSpA; adalimumab biosimilar; ASAS20; ASAS40; SURPASS
• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Axial Spondyloarthritis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Anti-Inflammatory Agents; Antirheumatic Agents; Tumor Necrosis Factor Inhibitors; Adalimumab
• Other Study ID Numbers: CAIN457K2340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No