AzTrials
AzTrials

Ankylosing SpondylitisPhase 3SURPASSNCT03259074

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

A Phase 3 study testing GP2017 (adalimumab biosimilar) and AIN457 150 mg in people with Ankylosing Spondylitis, run by Novartis Pharmaceuticals at 171 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
GP2017 (adalimumab biosimilar) and AIN457 150 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
859 participants
Where
171 sitesin 29 countries
Study dates
30 Nov 2017to 29 Nov 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

171 sites in 29 countries.

171 sites in 29 countries

United States19 sites

  • Novartis Investigative Site

    Boise, Idaho, 83702

  • Novartis Investigative Site

    Dayton, Ohio, 45402

  • Novartis Investigative Site

    Duncansville, Pennsylvania, 16635

  • Novartis Investigative Site

    Escondido, California, 92025

  • Novartis Investigative Site

    Franklin, Wisconsin, 53132

  • Novartis Investigative Site

    Gainesville, Florida, 32607

  • Novartis Investigative Site

    Great Falls, Montana, 59405

  • Novartis Investigative Site

    Greensboro, North Carolina, 27408

  • Novartis Investigative Site

    Kennewick, Washington, 99336

  • Novartis Investigative Site

    La Mesa, California, 91942

  • Novartis Investigative Site

    Lincoln, Nebraska, 68516

  • Novartis Investigative Site

    Memphis, Tennessee, 38119

  • Novartis Investigative Site

    Mesa, Arizona, 85202

  • Novartis Investigative Site

    Mesquite, Texas, 75150

  • Novartis Investigative Site

    Middleburg Heights, Ohio, 44130

  • Novartis Investigative Site

    Portland, Oregon, 97239

  • Novartis Investigative Site

    San Francisco, California, 94143 0138

  • Novartis Investigative Site

    Shreveport, Louisiana, 71101

  • Novartis Investigative Site

    Wheaton, Maryland, 20902

Other trials in United States

Germany15 sites

  • Novartis Investigative Site

    Bad Doberan, 18209

  • Novartis Investigative Site

    Bayreuth, 95444

  • Novartis Investigative Site

    Berlin, 12163

  • Novartis Investigative Site

    Berlin, 13125

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Berlin, 14059

  • Novartis Investigative Site

    Chemnitz, 09130

  • Novartis Investigative Site

    Erlangen, 91056

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Hamburg, 20095

  • Novartis Investigative Site

    Hamburg, 22415

  • Novartis Investigative Site

    Herne, 44649

  • Novartis Investigative Site

    Magdeburg, 39110

  • Novartis Investigative Site

    Planegg, 82152

  • Novartis Investigative Site

    Ratingen, 40878

Other trials in Germany

Russia15 sites

  • Novartis Investigative Site

    Barnaul, 656050

  • Novartis Investigative Site

    Chelyabinsk, 454076

  • Novartis Investigative Site

    Ivanovo, 153005

  • Novartis Investigative Site

    Kazan', 420097

  • Novartis Investigative Site

    Kemerovo, 650029

  • Novartis Investigative Site

    Kemerovo, 650066

  • Novartis Investigative Site

    Moscow, 115522

  • Novartis Investigative Site

    Moscow, 129110

  • Novartis Investigative Site

    Petrozavodsk, 185019

  • Novartis Investigative Site

    Saint Petersburg, 190068

  • Novartis Investigative Site

    Saint Petersburg, 197022

  • Novartis Investigative Site

    Saint Petersburg, 197341

  • Novartis Investigative Site

    Ufa, 450005

  • Novartis Investigative Site

    Yaroslavl, 150003

  • Novartis Investigative Site

    Yekaterinburg, 620137

Other trials in Russia

United Kingdom14 sites

  • Novartis Investigative Site

    Bath, BA1 3NG

  • Novartis Investigative Site

    Bristol, BS1 3NU

  • Novartis Investigative Site

    Christchurch, Dorset, BH23 2JX

  • Novartis Investigative Site

    Leicester, LE1 5WW

  • Novartis Investigative Site

    Leytonstone, London, E11 1NR

  • Novartis Investigative Site

    Liverpool, L9 7AL

  • Novartis Investigative Site

    London, Edmonton, N18 1QX

  • Novartis Investigative Site

    London, GBR, SW10 9NH

  • Novartis Investigative Site

    London, NW3 2QG

  • Novartis Investigative Site

    Norwich, NR4 7UY

  • Novartis Investigative Site

    Portsmouth, Hants, PO6 3LY

  • Novartis Investigative Site

    Stoke-on-Trent, Staffordshire, ST6 7AG

  • Novartis Investigative Site

    Torquay, TQ2 7AA

  • Novartis Investigative Site

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Spain12 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15006

  • Novartis Investigative Site

    Badalona, Catalonia, 08916

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Bilbao, Basque Country, 48013

  • Novartis Investigative Site

    Madrid, 28942

  • Novartis Investigative Site

    San Vicente de Barakaldo, Bizkaia, 48903

  • Novartis Investigative Site

    Santander, Cantabria, 39008

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

  • Novartis Investigative Site

    Valencia, 46009

  • Novartis Investigative Site

    Vigo, Pontevedra, 36200

  • Novartis Investigative Site

    Villajoyosa, Alicante, 703570

  • Novartis Investigative Site

    Vitoria-Gasteiz, Vitoria Gasteiz, 01009

Other trials in Spain

Japan8 sites

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 113-8431

  • Novartis Investigative Site

    Chuo Ku, Tokyo, 104-8560

  • Novartis Investigative Site

    Kita-gun, Kagawa-ken, 761-0793

  • Novartis Investigative Site

    Meguro City, Tokyo, 153-8515

  • Novartis Investigative Site

    Nankoku, Kochi, 783 8505

  • Novartis Investigative Site

    Nishinomiya, Hyōgo, 663 8501

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 160 8582

  • Novartis Investigative Site

    Tenri, Nara, 632-8552

Other trials in Japan

France7 sites

  • Novartis Investigative Site

    Boulogne-Billancourt, 92104

  • Novartis Investigative Site

    Le Mans, 72037

  • Novartis Investigative Site

    Monaco, 98000

  • Novartis Investigative Site

    Nice, Cedex1, 06001

  • Novartis Investigative Site

    Paris, 75012

  • Novartis Investigative Site

    Paris, 75679

  • Novartis Investigative Site

    Toulouse, 31059

Other trials in France

Portugal6 sites

  • Novartis Investigative Site

    Almada, 2801 951

  • Novartis Investigative Site

    Lisbon, 1050-034

  • Novartis Investigative Site

    Lisbon, 1349 019

  • Novartis Investigative Site

    Ponte de Lima, 4990 041

  • Novartis Investigative Site

    Porto, 4200 319

  • Novartis Investigative Site

    Vila Nova de Gaia, 4434 502

Other trials in Portugal

South Korea6 sites

  • Novartis Investigative Site

    Gwangju, 61469

  • Novartis Investigative Site

    Seoul, Seocho Gu, 06591

  • Novartis Investigative Site

    Seoul, 03080

  • Novartis Investigative Site

    Seoul, 04763

  • Novartis Investigative Site

    Seoul, 05278

  • Novartis Investigative Site

    Seoul, 06273

Other trials in South Korea

Turkey (Türkiye)6 sites

  • Novartis Investigative Site

    Ankara, 06230

  • Novartis Investigative Site

    Ankara, 06560

  • Novartis Investigative Site

    Eskişehir, 26040

  • Novartis Investigative Site

    Istanbul, TUR, 34098

  • Novartis Investigative Site

    Izmir, 35340

  • Novartis Investigative Site

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Czechia5 sites

  • Novartis Investigative Site

    Brno, 63800

  • Novartis Investigative Site

    Brno-Zidonice, CZE, 61500

  • Novartis Investigative Site

    Prague, 128 50

  • Novartis Investigative Site

    Prague, 14900

  • Novartis Investigative Site

    Uherské Hradiště, 686 01

Other trials in Czechia

Mexico5 sites

  • Novartis Investigative Site

    Culiacan, State of Mexico, 80000

  • Novartis Investigative Site

    Mexicali, Estado de Baja California, 21100

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64460

  • Novartis Investigative Site

    San Luis Potosí City, 78213

  • Novartis Investigative Site

    Torreón, Coahulia, 27000

Other trials in Mexico

Netherlands5 sites

  • Novartis Investigative Site

    Amsterdam, 1105 AZ

  • Novartis Investigative Site

    Leeuwarden, 8934 AD

  • Novartis Investigative Site

    Leiden, South Holland, 2333 ZA

  • Novartis Investigative Site

    Maastricht, 6229 HX

  • Novartis Investigative Site

    Rotterdam, 3079 DZ

Other trials in Netherlands

Poland5 sites

  • Novartis Investigative Site

    Bydgoszcz, 85 168

  • Novartis Investigative Site

    Dopiewo, 62 069

  • Novartis Investigative Site

    Krakow, 30 002

  • Novartis Investigative Site

    Poznan, 61 113

  • Novartis Investigative Site

    Sopot, 81 756

Other trials in Poland

Slovakia5 sites

  • Novartis Investigative Site

    Bratislava, Slovak Republic, 813 69

  • Novartis Investigative Site

    Bratislava, 85101

  • Novartis Investigative Site

    Košice, 04011

  • Novartis Investigative Site

    Piešťany, SVK, 921 12

  • Novartis Investigative Site

    Stará Ľubovňa, 06401

Other trials in Slovakia

Taiwan5 sites

  • Novartis Investigative Site

    Dalin, 622

  • Novartis Investigative Site

    Kaohsiung City, 80756

  • Novartis Investigative Site

    Kaohsiung City, 81346

  • Novartis Investigative Site

    Taichung, Taiwan ROC, 40201

  • Novartis Investigative Site

    Taipei, 10048

Other trials in Taiwan

Canada4 sites

  • Novartis Investigative Site

    Barrie, Ontario, L4M 6L2

  • Novartis Investigative Site

    Québec, Quebec, G1V 3M7

  • Novartis Investigative Site

    Trois-Rivières, Quebec, G8Z 1Y2

  • Novartis Investigative Site

    Winnipeg, Manitoba, R3A 1M1

Other trials in Canada

Chile4 sites

  • Novartis Investigative Site

    Concepción

  • Novartis Investigative Site

    Santiago, RM, 7500588

  • Novartis Investigative Site

    Santiago, 8207257

  • Novartis Investigative Site

    Santiago

Other trials in Chile

Peru4 sites

  • Novartis Investigative Site

    Jesus Maria, Lima region, 11

  • Novartis Investigative Site

    Lima, 1

  • Novartis Investigative Site

    San Isidro, Lima region, 27

  • Novartis Investigative Site

    Santiago de Surco, Lima region, 33

Other trials in Peru

Greece3 sites

  • Novartis Investigative Site

    Athens, 115 27

  • Novartis Investigative Site

    Athens, 145 61

  • Novartis Investigative Site

    Thessaloniki, GR, 564 29

Other trials in Greece

Israel3 sites

  • Novartis Investigative Site

    Haifa, 3109601

  • Novartis Investigative Site

    Haifa, 3339419

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Philippines3 sites

  • Novartis Investigative Site

    Manila, 1008

  • Novartis Investigative Site

    Quezon City, 1102

  • Novartis Investigative Site

    Quezon City, 1118

Other trials in Philippines

Romania3 sites

  • Novartis Investigative Site

    Bucharest, 011172

  • Novartis Investigative Site

    Bucharest, 030167

  • Novartis Investigative Site

    Cluj-Napoca, 400006

Other trials in Romania

Belgium2 sites

  • Novartis Investigative Site

    Brussels, 1070

  • Novartis Investigative Site

    Genk, 3600

Other trials in Belgium

Colombia2 sites

  • Novartis Investigative Site

    Barranquilla, 080020

  • Novartis Investigative Site

    Bucaramanga, Santander Department, 0001

Other trials in Colombia

Denmark2 sites

  • Novartis Investigative Site

    Aalborg, DK 9000

  • Novartis Investigative Site

    Copenhagen, 2100

Other trials in Denmark

Argentina1 site

  • Novartis Investigative Site

    Ciudad Autonoma de Bs As, C1428AZF

Other trials in Argentina

Australia1 site

  • Novartis Investigative Site

    Malvern East, Victoria, 3145

Other trials in Australia

Finland1 site

  • Novartis Investigative Site

    Joensuu, 80210

Other trials in Finland

About this study

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

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).

Read the 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.

.

Being tested
Placebo, GP2017 (adalimumab biosimilar), AIN457 150 mg
Keywords
ankylosing spondylitis, AS, secukinumab, GP2017, adalimumab biosimilar, mSASSS, ASAS20, ASAS40, adult, r-axSpA, AIN457, radiographic, SURPASS
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboBiological

    Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes

  • GP2017 (adalimumab biosimilar)Biological

    Also called adalimumab biosimilar

    40 mg in pre-filled syringes was administered subcutaneously

  • AIN457 150 mgBiological

    Also called secukinumab

    150 mg in pre-filled syringes was administered subcutaneously

Study groups in NCT03259074
Study groupRoleWhat they receive
AIN457 150 mg/placeboExperimentalAIN457 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
Receives: Biological: Placebo; Biological: AIN457 150 mg
AIN457 300 mgExperimentalAIN457 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
Receives: Biological: AIN457 150 mg
GP2017 40mgActive comparatorGP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 102
Receives: Biological: GP2017 (adalimumab biosimilar)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and at Week 104

Secondary outcomes (8)

  1. 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.

    Measured: Baseline and at Week 104

  2. 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).

    Measured: Baseline and at Week 104

  3. 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.

    Measured: Baseline and at Week 104

  4. 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.

    Measured: Baseline and at Week 104

  5. 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.

    Measured: Week 104

  6. 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.

    Measured: Week 104

  7. 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.

    Measured: Week 104

  8. 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).

    Measured: Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2017
  2. Study start30 Nov 2017
  3. Primary completion12 Nov 2021
  4. Study completion29 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Study was partially blinded. Subjects, investigators, site personnel, persons performing the assessments, monitors and the Sponsor remained blinded to the dose group of secukinumab (150 mg versus 300 mg)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
859 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03259074
Sponsor's protocol ID
CAIN457K2340
Acronym
SURPASS
Status last verified
Aug 2023
First submitted
21 Aug 2017
Last updated
21 Aug 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

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.

    PubMed 33978600

  • 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.

    PubMed 31983056

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GP2017 (adalimumab biosimilar) and AIN457 150 mg in people with Ankylosing Spondylitis, run by Novartis Pharmaceuticals at 171 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 171 sites in United States, Germany, Russia, United Kingdom, Spain and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set) (time frame: Baseline and at Week 104). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03259074, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.

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