Back to results

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

Primary Purpose

Ankylosing Spondylitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

GP2017 (adalimumab biosimilar)

AIN457 150 mg

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring ankylosing spondylitis, AS, secukinumab, GP2017, adalimumab biosimilar, mSASSS, ASAS20, ASAS40, adult, r-axSpA, AIN457, radiographic, SURPASS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

AIN457 150 mg/placebo

AIN457 300 mg

GP2017 40mg

Arm Description

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

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

GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 102

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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).

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.

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.

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.

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.

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.

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).

Full Information

NCT ID

NCT03259074

First Posted

August 21, 2017

Last Updated

August 16, 2023

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03259074

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

November 30, 2017 (Actual)

Primary Completion Date

November 12, 2021 (Actual)

Study Completion Date

November 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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).

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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankylosing Spondylitis

Keywords

ankylosing spondylitis, AS, secukinumab, GP2017, adalimumab biosimilar, mSASSS, ASAS20, ASAS40, adult, r-axSpA, AIN457, radiographic, SURPASS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

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

Outcomes Assessor

Masking Description

The Participant, Care Provider, Investigator and Sponsor are blinded to Secukinumab dose

Allocation

Randomized

Enrollment

859 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AIN457 150 mg/placebo

Arm Type

Experimental

Arm Description

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

Arm Title

AIN457 300 mg

Arm Type

Experimental

Arm Description

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

Arm Title

GP2017 40mg

Arm Type

Active Comparator

Arm Description

GP2017 (adalimumab biosimilar) 40 mg was administered subcutaneously via pre-filled syringes at Baseline followed by dosing every 2 weeks until Week 102

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

GP2017 (adalimumab biosimilar)

Other Intervention Name(s)

adalimumab biosimilar

Intervention Description

40 mg in pre-filled syringes was administered subcutaneously

Intervention Type

Biological

Intervention Name(s)

AIN457 150 mg

Other Intervention Name(s)

secukinumab

Intervention Description

150 mg in pre-filled syringes was administered subcutaneously

Primary Outcome Measure Information:

Title

Percentage of Participants With no Radiographic Progression at Week 104 (Multiple Imputation) (Full Analysis Set)

Description

Time Frame

Baseline and at Week 104

Secondary Outcome Measure Information:

Title

Change From Baseline in mSASSS at Week 104 (Multiple Imputation) (Full Analysis Set)

Description

Time Frame

Baseline and at Week 104

Title

Percentage of Participants Without New Syndesmophytes by mSASSS Between Baseline and Week 104 (Multiple Imputation) (Syndesmophyte Subset)

Description

Time Frame

Baseline and at Week 104

Title

Change From Baseline in MRI Berlin Sacroiliac (SI) Joint Edema Score (Observed Data) (MRI Subset)

Description

Time Frame

Baseline and at Week 104

Title

Change From Baseline in Berlin Modification of ASspiMRI-a Edema Score (MRI Subset)

Description

Time Frame

Baseline and at Week 104

Title

Percentage of Responders for Assessment of SpondyloArthritis International Society 20 (ASAS20)

Description

Time Frame

Week 104

Title

Percentage of Responders for Assessment of SpondyloArthritis International Society 40 (ASAS 40)

Description

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.

Time Frame

Week 104

Title

Percentage of Responders for Assessment of SpondyloArthritis International Society With a Partial Remission Response (Full Analysis Set)

Description

Time Frame

Week 104

Title

Percentage of Participants With Assessment of SpondyloArthritis International Society for Inactive Disease Response (Observed Data) (Full Analysis Set)

Description

Time Frame

Week 104

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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

Facility Information:

Facility Name

Novartis Investigative Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85202

Country

United States

Facility Name

Novartis Investigative Site

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

Novartis Investigative Site

City

La Mesa

State/Province

California

ZIP/Postal Code

91942

Country

United States

Facility Name

Novartis Investigative Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94143 0138

Country

United States

Facility Name

Novartis Investigative Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Novartis Investigative Site

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

Novartis Investigative Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71101

Country

United States

Facility Name

Novartis Investigative Site

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Novartis Investigative Site

City

Great Falls

State/Province

Montana

ZIP/Postal Code

59405

Country

United States

Facility Name

Novartis Investigative Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

Novartis Investigative Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27408

Country

United States

Facility Name

Novartis Investigative Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45402

Country

United States

Facility Name

Novartis Investigative Site

City

Middleburg Heights

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

Facility Name

Novartis Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Novartis Investigative Site

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Novartis Investigative Site

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38119

Country

United States

Facility Name

Novartis Investigative Site

City

Mesquite

State/Province

Texas

ZIP/Postal Code

75150

Country

United States

Facility Name

Novartis Investigative Site

City

Kennewick

State/Province

Washington

ZIP/Postal Code

99336

Country

United States

Facility Name

Novartis Investigative Site

City

Franklin

State/Province

Wisconsin

ZIP/Postal Code

53132

Country

United States

Facility Name

Novartis Investigative Site

City

Ciudad Autonoma de Bs As

ZIP/Postal Code

C1428AZF

Country

Argentina

Facility Name

Novartis Investigative Site

City

Malvern East

State/Province

Victoria

ZIP/Postal Code

3145

Country

Australia

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Novartis Investigative Site

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Novartis Investigative Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1M1

Country

Canada

Facility Name

Novartis Investigative Site

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 6L2

Country

Canada

Facility Name

Novartis Investigative Site

City

Trois Rivieres

State/Province

Quebec

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

Novartis Investigative Site

City

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

Facility Name

Novartis Investigative Site

City

Santiago

State/Province

ZIP/Postal Code

7500588

Country

Chile

Facility Name

Novartis Investigative Site

City

Concepcion

Country

Chile

Facility Name

Novartis Investigative Site

City

Santiago

ZIP/Postal Code

8207257

Country

Chile

Facility Name

Novartis Investigative Site

City

Santiago

Country

Chile

Facility Name

Novartis Investigative Site

City

Bucaramanga

State/Province

Santander

ZIP/Postal Code

0001

Country

Colombia

Facility Name

Novartis Investigative Site

City

Barranquilla

ZIP/Postal Code

080020

Country

Colombia

Facility Name

Novartis Investigative Site

City

Brno-Zidonice

State/Province

CZE

ZIP/Postal Code

61500

Country

Czechia

Facility Name

Novartis Investigative Site

City

Brno

ZIP/Postal Code

63800

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 11

ZIP/Postal Code

14900

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 2

ZIP/Postal Code

128 50

Country

Czechia

Facility Name

Novartis Investigative Site

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Aalborg

ZIP/Postal Code

DK 9000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Facility Name

Novartis Investigative Site

City

Joensuu

ZIP/Postal Code

80210

Country

Finland

Facility Name

Novartis Investigative Site

City

Nice

State/Province

Cedex1

ZIP/Postal Code

06001

Country

France

Facility Name

Novartis Investigative Site

City

Boulogne Billancourt

ZIP/Postal Code

92104

Country

France

Facility Name

Novartis Investigative Site

City

Le Mans

ZIP/Postal Code

72037

Country

France

Facility Name

Novartis Investigative Site

City

Monaco

ZIP/Postal Code

98000

Country

France

Facility Name

Novartis Investigative Site

City

Paris Cedex 14

ZIP/Postal Code

75679

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Novartis Investigative Site

City

Bad Doberan

ZIP/Postal Code

18209

Country

Germany

Facility Name

Novartis Investigative Site

City

Bayreuth

ZIP/Postal Code

95444

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

12163

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

Novartis Investigative Site

City

Chemnitz

ZIP/Postal Code

09130

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91056

Country

Germany

Facility Name

Novartis Investigative Site

City

Gottingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20095

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22415

Country

Germany

Facility Name

Novartis Investigative Site

City

Herne

ZIP/Postal Code

44649

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

ZIP/Postal Code

39110

Country

Germany

Facility Name

Novartis Investigative Site

City

Planegg

ZIP/Postal Code

82152

Country

Germany

Facility Name

Novartis Investigative Site

City

Ratingen

ZIP/Postal Code

40878

Country

Germany

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

564 29

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

145 61

Country

Greece

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

3339419

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Novartis Investigative Site

City

Nishinomiya

State/Province

Hyogo

ZIP/Postal Code

663 8501

Country

Japan

Facility Name

Novartis Investigative Site

City

Kita-gun

State/Province

Kagawa

ZIP/Postal Code

761-0793

Country

Japan

Facility Name

Novartis Investigative Site

City

Nankoku city

State/Province

Kochi

ZIP/Postal Code

783 8505

Country

Japan

Facility Name

Novartis Investigative Site

City

Tenri

State/Province

Nara

ZIP/Postal Code

632-8552

Country

Japan

Facility Name

Novartis Investigative Site

City

Bunkyo ku

State/Province

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

Novartis Investigative Site

City

Chuo ku

State/Province

Tokyo

ZIP/Postal Code

104-8560

Country

Japan

Facility Name

Novartis Investigative Site

City

Meguro

State/Province

Tokyo

ZIP/Postal Code

153-8515

Country

Japan

Facility Name

Novartis Investigative Site

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

160 8582

Country

Japan

Facility Name

Novartis Investigative Site

City

Seoul

State/Province

Seocho Gu

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Gwangju

ZIP/Postal Code

61469

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

04763

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

05278

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Seoul

ZIP/Postal Code

06273

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Mexicali

State/Province

Baja California

ZIP/Postal Code

21100

Country

Mexico

Facility Name

Novartis Investigative Site

City

Torreon

State/Province

Coahulia

ZIP/Postal Code

27000

Country

Mexico

Facility Name

Novartis Investigative Site

City

Culiacan

State/Province

MEX

ZIP/Postal Code

80000

Country

Mexico

Facility Name

Novartis Investigative Site

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64460

Country

Mexico

Facility Name

Novartis Investigative Site

City

San Luis potosi

ZIP/Postal Code

78213

Country

Mexico

Facility Name

Novartis Investigative Site

City

Leiden

State/Province

Zuid-Holland

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Leeuwarden

ZIP/Postal Code

8934 AD

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3079 DZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Jesus Maria

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

San Isidro

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Santiago de Surco

State/Province

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Novartis Investigative Site

City

Manila

ZIP/Postal Code

1008

Country

Philippines

Facility Name

Novartis Investigative Site

City

Quezon City

ZIP/Postal Code

1102

Country

Philippines

Facility Name

Novartis Investigative Site

City

Quezon City

ZIP/Postal Code

1118

Country

Philippines

Facility Name

Novartis Investigative Site

City

Bydgoszcz

ZIP/Postal Code

85 168

Country

Poland

Facility Name

Novartis Investigative Site

City

Dopiewo

ZIP/Postal Code

62 069

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

30 002

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

61 113

Country

Poland

Facility Name

Novartis Investigative Site

City

Sopot

ZIP/Postal Code

81 756

Country

Poland

Facility Name

Novartis Investigative Site

City

Almada

ZIP/Postal Code

2801 951

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1050-034

Country

Portugal

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1349 019

Country

Portugal

Facility Name

Novartis Investigative Site

City

Ponte de Lima

ZIP/Postal Code

4990 041

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4200 319

Country

Portugal

Facility Name

Novartis Investigative Site

City

Vila Nova de Gaia

ZIP/Postal Code

4434 502

Country

Portugal

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

030167

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucuresti

ZIP/Postal Code

011172

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj Napoca

ZIP/Postal Code

400006

Country

Romania

Facility Name

Novartis Investigative Site

City

Barnaul

ZIP/Postal Code

656050

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Chelyabinsk

ZIP/Postal Code

454076

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ekaterinburg

ZIP/Postal Code

620137

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ivanovo

ZIP/Postal Code

153005

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420097

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kemerovo

ZIP/Postal Code

650029

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kemerovo

ZIP/Postal Code

650066

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Moscow

ZIP/Postal Code

129110

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

197341

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ufa

ZIP/Postal Code

450005

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Bratislava

State/Province

Slovak Republic

ZIP/Postal Code

813 69

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Piestany

State/Province

SVK

ZIP/Postal Code

921 12

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

85101

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Kosice

ZIP/Postal Code

04011

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Stara Lubovna

ZIP/Postal Code

06401

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Villajoyosa

State/Province

Alicante

ZIP/Postal Code

703570

Country

Spain

Facility Name

Novartis Investigative Site

City

San Vicente De Barakaldo

State/Province

Bizkaia

ZIP/Postal Code

48903

Country

Spain

Facility Name

Novartis Investigative Site

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Novartis Investigative Site

City

Badalona

State/Province

Catalunya

ZIP/Postal Code

08916

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08003

Country

Spain

Facility Name

Novartis Investigative Site

City

La Coruna

State/Province

Galicia

ZIP/Postal Code

15006

Country

Spain

Facility Name

Novartis Investigative Site

City

Santiago de Compostela

State/Province

Galicia

ZIP/Postal Code

15706

Country

Spain

Facility Name

Novartis Investigative Site

City

Bilbao

State/Province

Pais Vasco

ZIP/Postal Code

48013

Country

Spain

Facility Name

Novartis Investigative Site

City

Vigo

State/Province

Pontevedra

ZIP/Postal Code

36200

Country

Spain

Facility Name

Novartis Investigative Site

City

Vitoria

State/Province

Vitoria Gasteiz

ZIP/Postal Code

01009

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28942

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

Novartis Investigative Site

City

Taichung

State/Province

Taiwan ROC

ZIP/Postal Code

40201

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Dalin

ZIP/Postal Code

622

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Kaohsiung

ZIP/Postal Code

80756

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Kaohsiung

ZIP/Postal Code

81346

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taipei

ZIP/Postal Code

10048

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Istanbul

State/Province

TUR

ZIP/Postal Code

34098

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06230

Country

Turkey

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06560

Country

Turkey

Facility Name

Novartis Investigative Site

City

Eskisehir

ZIP/Postal Code

26040

Country

Turkey

Facility Name

Novartis Investigative Site

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

Facility Name

Novartis Investigative Site

City

Kocaeli

ZIP/Postal Code

41380

Country

Turkey

Facility Name

Novartis Investigative Site

City

Christchurch

State/Province

Dorset

ZIP/Postal Code

BH23 2JX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

State/Province

Edmonton

ZIP/Postal Code

N18 1QX

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

State/Province

GBR

ZIP/Postal Code

SW10 9NH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Portsmouth

State/Province

Hants

ZIP/Postal Code

PO6 3LY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leytonstone

State/Province

London

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Stoke on Trent

State/Province

Staffordshire

ZIP/Postal Code

ST6 7AG

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bath

ZIP/Postal Code

BA1 3NG

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bristol

ZIP/Postal Code

BS1 3NU

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leicester

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Liverpool

ZIP/Postal Code

L9 7AL

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Norwich

ZIP/Postal Code

NR4 7UY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Torquay

ZIP/Postal Code

TQ2 7AA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Wolverhampton

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

33978600

Citation

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.

Results Reference

derived

PubMed Identifier

31983056

Citation

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.

Results Reference

derived

Links:

URL

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=1307

Description

A Plain Language Trial Summary is available on novctrd.com

Learn more about this trial

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

We'll reach out to this number within 24 hrs

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

Ankylosing Spondylitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial