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Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis (PREVENT)

Primary Purpose

Non-radiographic Spondyloarthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Secukinumab

Placebo

About this trial

This is an interventional treatment trial for Non-radiographic Spondyloarthritis focused on measuring non-radiographic spondyloarthritis, axial spondyloarthritis, Ankylosing Spondylitis

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 axial spondyloarthritis according to Ankylosing SpondyloArthritis International Society (ASAS) axial spondyloarthritis criteria
objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
active axial spondyloarthritis as assessed by total Bath Ankylosing Spondylitis Disease Activity Index >=4 cm
Spinal pain as measured by Bath Ankylosing Spondylitis Disease Activity Index question #2 ≥ 4 cm (0-10 cm) at baseline
Total back pain as measured by Visual Analogue scale ≥ 40 mm (0-100 mm) at baseline
Patients should have been on at least 2 different non-steroidal anti-inflammatory drugs with an inadequate response
Patients who have been on a Tumor Necrosis Factor (TNF) α inhibitor (not more than one) must have experienced an inadequate response

Exclusion Criteria:

Patients with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally
Inability or unwillingness to undergo MRI
Chest X-ray or MRI with evidence of ongoing infectious or malignant process
Patients taking high potency opioid analgesics
Previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor
Pregnant or nursing (lactating) women

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Secukinumab, 150 mg Load (Core phase)

Secukinumab, 150 mg No Load (Core phase)

Placebo (Core phase)

Core Phase Responder 150 mg (Extension phase)

Core Phase Responder 300 mg (Extension phase)

Core Phase Non-Responder 300 mg (Extension phase)

Arm Description

Secukinumab 150 mg s.c., pre-filled syringe (PFS) at baseline, Weeks 1, 2, and 3, followed by administration every four weeks starting at Week 4, Load, Core phase

Secukinumab 150 mg s.c. PFS at baseline, placebo at Weeks 1, 2, and 3, followed by secukinumab 150 mg PFS administration every four weeks starting at Week 4, No Load, Core phase

Placebo s.c., PFS at baseline, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4, Core phase

Core Phase Responder 150 mg blinded: secukinumab 150 mg s.c. PFS and placebo (1 mL) s.c. PFS every four weeks, in the Extension phase

Core Phase Responder 300 mg blinded: 2 injections with secukinumab 150 mg s.c. PFS every four weeks, in the Extension phase

Core Phase Non-Responder 300 mg: 2 injections with secukinumab 150 mg s.c. PFS every four weeks open-label, in the Extension phase

Outcomes

Primary Outcome Measures

The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response at Week 16

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). 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.

The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 52

Secondary Outcome Measures

The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response

The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 20 Response

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). 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.

The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains. A higher score on the VAS signifies higher severity.

The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society Partial Remission (ASAS PR)

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 10. A higher score on the VAS signifies higher severity.

Change in Bath Ankylosing Spondylitis Functional Index (BASFI)

The Bath Ankylosing Spondylitis Functional Index (BASFI) is a set of 10 questions designed to determine the degree of functional limitation in those subjects with AS. The ten questions were chosen with a major input from subjects with AS. The first 8 questions consider activities related to functional anatomy. The final 2 questions assess the subjects' ability to cope with everyday life. A 100 mm visual analog scale (VAS) is used to answer the questions. The mean of the ten questions gives the BASFI score - a value between 0 and 10. (0 being no problem and 10 being the worst problem, captured as a continuous visual analog scale (VAS)). A higher score on the VAS signifies higher severity.

The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response

The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous VAS), which is used to answer 6 questions pertaining to the 5 major symptoms of AS. The BASDAI 50 is defined as an improvement of at least 50% in the BASDAI compared to baseline. A higher score on the VAS signifies higher severity.

Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a validated assessment tool using 1 through 10 scales (1 indicating "no problem" and 10 indicating " worst problem"), to characterize six clinical domains (fatigue, spinal pain, joint pain/selling, localized tenderness, morning stiffness duration, morning stiffness severity) pertaining to five major symptoms of Ankylosing Spondylitis (AS). The computed final BASDAI score is a value between 0 and 10 with a higher score indicating worse disease. A higher score on the VAS signifies higher severity.

Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 16

The Ankylosing Spondylitis Quality of Life scores (ASQoL) is a self-administered questionnaire designed to assess health-related quality of life in adult patients with Ankylosing Spondylitis. The ASQoL contains 18 items with a dichotomous yes/no response option. A single point is assigned for each "yes" response and no points for each "no" response resulting in overall scores that range from 0 (least severity) to 18 (highest severity). As such, lower score indicate better quality of life. Items include an assessment of mobility/energy, self-care and mood/emotion. The recall period is "at the moment," and the measure requires approximately 6 minutes to complete.

Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 52

The Number and Percentage of Patients Who Achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease

Ankylosing Spondylitis Disease Activity Score (ASDAS) - C-reactive protein (CRP) inactive disease criteria are defined as a value below 1.3. Higher score indicates worse symptoms. The formula is: ASDAS-CRP = 0.121 x total back pain + 0.110 x patient global + 0.073 x peripheral pain/swelling + 0.058 x duration of morning stiffness + 0.579 x ln(hsCRP +1)

Change in High Sensitivity C-reactive Protein

High sensitivity C-reactive protein is measured as a marker of inflammation from blood samples during the study.

Change in Short Form-36 Physical Component Summary (SF-36 PCS)

The Short Form-36 Physical Component Summary (SF-36 PCS) is an instrument to measure health-related quality of life among healthy patients and patients with acute and chronic conditions. It consists of eight subscales (domains) that can be scored individually: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role- Emotional, and Mental Health. Two overall summary scores, the Physical Component Summary (PCS) and the Mental Component Summary (MCS) also can be computed. The eight domains are based on a scale from 0-100 while PCS and MCS are norm-based scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a higher level of functioning. A positive change from baseline score indicates an improvement.

Change in Sacroiliac Joint Edema - Week 16

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 maximum score of 24.

Change in Sacroiliac Joint Edema - Week 52

Full Information

NCT ID

NCT02696031

First Posted

October 13, 2015

Last Updated

April 4, 2022

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02696031

Brief Title

Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis

Acronym

PREVENT

Official Title

A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab 150 mg in Patients With Active nr- axSpA to Evaluate the Safety,Tolerability and Efficacy up to 2 Yrs, Followed by an Opt Phase of Either 150 mg or 300 mg Randomized Dose Escalation for up to Another 2 Yrs

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

April 29, 2016 (Actual)

Primary Completion Date

July 1, 2019 (Actual)

Study Completion Date

March 11, 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 was to demonstrate the clinical efficacy, safety and tolerability of secukinumab compared to placebo in patients with nr-axSpA at Week 16 as well as Week 52 and long term efficacy and safety up to Week 104 (core phase) followed by an optional extension phase consisting of a 16-week randomized dose escalation treatment period and a continuous treatment period for up to Week 208

Detailed Description

Patients were randomized to one of three treatment groups (1:1:1) in the core phase: Secukinumab 150 mg Load: secukinumab 150 mg (1 mL, 150 mg/mL) s.c. pre-filled syringe (PFS) at baseline, Weeks 1, 2, and 3, followed by administration every four weeks starting at Week 4 Secukinumab 150 mg No Load: secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS at baseline, placebo at Weeks 1, 2, and 3, followed by secukinumab 150 mg PFS administration every four weeks starting at Week 4 Placebo: placebo (1 mL) s.c. PFS at baseline, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4. All patients received secukinumab 150 mg as open-label treatment from Week 52 up to Week 100, unless they had discontinued study treatment. At Week 104, all patients who finished the core phase according to the protocol were asked to continue in an optional, exploratory extension phase. Patients who achieved ASAS20 response at Week 104 (Core Phase Responders) were randomized to the following treatment groups (blinded) in the extension phase: Core Phase Responder 150 mg: secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS and placebo (1 mL) s.c. PFS every four weeks; Core Phase Responder 300 mg: 2 injections with secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS every four weeks. Core Phase Non-Responders (not achieving ASAS20 at Week 104) were escalated to secukinumab 300 mg in an open-label manner. - Core Phase Non-Responder 300 mg: 2 injections with secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS every four weeks open-label. Starting from Week 156 onward, a patient could switch to secukinumab 300 mg open-label based on the clinical judgment of disease activity by the investigator.

6. Conditions and Keywords

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

Non-radiographic Spondyloarthritis

Keywords

non-radiographic spondyloarthritis, axial spondyloarthritis, Ankylosing Spondylitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

This was a randomized, double-blind, placebo-controlled study. Approximately 555 patients were randomized to one of three treatment groups (secukinumab 150 mg Load, secukinumab 150 mg No Load or placebo in a ratio of 1:1:1): Group 1 (secukinumab 150 mg Load): secukinumab 150 mg (1 mL, 150 mg/mL) s.c. prefilled syringe (PFS) at baseline (BSL), Weeks 1, 2 and 3, followed by administration every four weeks starting at Week 4 Group 2 (secukinumab 150 mg No Load): secukinumab 150 mg (1 mL, 150 mg/mL) s.c. PFS at BSL, placebo at Weeks 1, 2 and 3, followed by secukinumab 150 mg PFS administration every four weeks starting at Week 4 Group 3 (placebo): placebo (1 mL) s.c. PFS at BSL, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4 Based on the clinical judgment of disease activity by the investigator and the patient, background medications, such as NSAIDs and DMARDs, may have been modified or added to treat signs and symptoms of nr-axSpA from Week 16 on.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

555 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Secukinumab, 150 mg Load (Core phase)

Arm Type

Experimental

Arm Description

Secukinumab 150 mg s.c., pre-filled syringe (PFS) at baseline, Weeks 1, 2, and 3, followed by administration every four weeks starting at Week 4, Load, Core phase

Arm Title

Secukinumab, 150 mg No Load (Core phase)

Arm Type

Experimental

Arm Description

Secukinumab 150 mg s.c. PFS at baseline, placebo at Weeks 1, 2, and 3, followed by secukinumab 150 mg PFS administration every four weeks starting at Week 4, No Load, Core phase

Arm Title

Placebo (Core phase)

Arm Type

Placebo Comparator

Arm Description

Placebo s.c., PFS at baseline, Weeks 1, 2, 3, followed by administration every four weeks starting at Week 4, Core phase

Arm Title

Core Phase Responder 150 mg (Extension phase)

Arm Type

Experimental

Arm Description

Core Phase Responder 150 mg blinded: secukinumab 150 mg s.c. PFS and placebo (1 mL) s.c. PFS every four weeks, in the Extension phase

Arm Title

Core Phase Responder 300 mg (Extension phase)

Arm Type

Experimental

Arm Description

Core Phase Responder 300 mg blinded: 2 injections with secukinumab 150 mg s.c. PFS every four weeks, in the Extension phase

Arm Title

Core Phase Non-Responder 300 mg (Extension phase)

Arm Type

Experimental

Arm Description

Core Phase Non-Responder 300 mg: 2 injections with secukinumab 150 mg s.c. PFS every four weeks open-label, in the Extension phase

Intervention Type

Drug

Intervention Name(s)

Secukinumab

Other Intervention Name(s)

AIN457

Intervention Description

Induction: 4x 150 mg Secukinumab s.c. weekly Maintenance: 150 mg Secukinumab s.c. monthly

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

AIN457

Intervention Description

Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly

Primary Outcome Measure Information:

Title

The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response at Week 16

Description

Time Frame

Week 16

Title

The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 52

Description

Time Frame

Week 52

Secondary Outcome Measure Information:

Title

The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response

Description

Time Frame

Week 16 and week 52

Title

The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 20 Response

Description

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). 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.

Time Frame

Week 16

Title

The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response

Description

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). The ASAS 5/6 improvement criteria is an improvement of ≥20% in at least five of all six domains. A higher score on the VAS signifies higher severity.

Time Frame

Week 16

Title

The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society Partial Remission (ASAS PR)

Description

Assessment of SpondyloArthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a visual analog scale (VAS); 2. Patient's assessment of back pain, measured on a VAS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by VAS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by VAS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). The ASAS partial remission criteria are defined as a value not above 2 units in each of the four main domains on a scale of 10. A higher score on the VAS signifies higher severity.

Time Frame

Week 16

Title

Change in Bath Ankylosing Spondylitis Functional Index (BASFI)

Description

Time Frame

Baseline and Week 16

Title

The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response

Description

Time Frame

Week 16 and 52

Title

Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Description

Time Frame

Baseline and Week 16

Title

Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 16

Description

Time Frame

Baseline and Week 16

Title

Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 52

Description

Time Frame

Baseline and Week 52

Title

The Number and Percentage of Patients Who Achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease

Description

Time Frame

Week 52

Title

Change in High Sensitivity C-reactive Protein

Description

High sensitivity C-reactive protein is measured as a marker of inflammation from blood samples during the study.

Time Frame

Baseline and Week 16

Title

Change in Short Form-36 Physical Component Summary (SF-36 PCS)

Description

Time Frame

Baseline and Week 16

Title

Change in Sacroiliac Joint Edema - Week 16

Description

Time Frame

Baseline and Week 16

Title

Change in Sacroiliac Joint Edema - Week 52

Description

Time Frame

Baseline and Week 52

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 axial spondyloarthritis according to Ankylosing SpondyloArthritis International Society (ASAS) axial spondyloarthritis criteria objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein) active axial spondyloarthritis as assessed by total Bath Ankylosing Spondylitis Disease Activity Index >=4 cm Spinal pain as measured by Bath Ankylosing Spondylitis Disease Activity Index question #2 ≥ 4 cm (0-10 cm) at baseline Total back pain as measured by Visual Analogue scale ≥ 40 mm (0-100 mm) at baseline Patients should have been on at least 2 different non-steroidal anti-inflammatory drugs with an inadequate response Patients who have been on a Tumor Necrosis Factor (TNF) α inhibitor (not more than one) must have experienced an inadequate response Exclusion Criteria: Patients with radiographic evidence for sacroiliitis, grade ≥ 2 bilaterally or grade ≥ 3 unilaterally Inability or unwillingness to undergo MRI Chest X-ray or MRI with evidence of ongoing infectious or malignant process Patients taking high potency opioid analgesics Previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor Pregnant or nursing (lactating) women

Facility Information:

Facility Name

Novartis Investigative Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Novartis Investigative Site

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

Novartis Investigative Site

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Novartis Investigative Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Novartis Investigative Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

Facility Name

Novartis Investigative Site

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Novartis Investigative Site

City

Bowling Green

State/Province

Kentucky

ZIP/Postal Code

42101

Country

United States

Facility Name

Novartis Investigative Site

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

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

Albany

State/Province

New York

ZIP/Postal Code

12206

Country

United States

Facility Name

Novartis Investigative Site

City

Potsdam

State/Province

New York

ZIP/Postal Code

13676

Country

United States

Facility Name

Novartis Investigative Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73102

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

Charleston

State/Province

South Carolina

ZIP/Postal Code

29460

Country

United States

Facility Name

Novartis Investigative Site

City

Leander

State/Province

Texas

ZIP/Postal Code

78641

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

Coffs Harbour

State/Province

New South Wales

ZIP/Postal Code

2450

Country

Australia

Facility Name

Novartis Investigative Site

City

Maroochydore

State/Province

Queensland

ZIP/Postal Code

4558

Country

Australia

Facility Name

Novartis Investigative Site

City

Hobart

State/Province

Tasmania

ZIP/Postal Code

7000

Country

Australia

Facility Name

Novartis Investigative Site

City

Malvern East

State/Province

Victoria

ZIP/Postal Code

3145

Country

Australia

Facility Name

Novartis Investigative Site

City

Woolloongabba

ZIP/Postal Code

QLD 4102

Country

Australia

Facility Name

Novartis Investigative Site

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novartis Investigative Site

City

Vienna

ZIP/Postal Code

A-1060

Country

Austria

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1606

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Praha 11

State/Province

Czech Republic

ZIP/Postal Code

148 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 2

State/Province

Czech Republic

ZIP/Postal Code

128 50

Country

Czechia

Facility Name

Novartis Investigative Site

City

Praha 5

State/Province

Czech Republic

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Novartis Investigative Site

City

Brno-Zidonice

State/Province

CZE

ZIP/Postal Code

61500

Country

Czechia

Facility Name

Novartis Investigative Site

City

Brno

State/Province

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Novartis Investigative Site

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

Novartis Investigative Site

City

Limoges cedex

State/Province

Haute Vienne

ZIP/Postal Code

87000

Country

France

Facility Name

Novartis Investigative Site

City

Bordeaux Cedex

ZIP/Postal Code

33076

Country

France

Facility Name

Novartis Investigative Site

City

Boulogne Billancourt

ZIP/Postal Code

92104

Country

France

Facility Name

Novartis Investigative Site

City

Chambray les Tours

ZIP/Postal Code

37170

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

Poitiers

ZIP/Postal Code

86021

Country

France

Facility Name

Novartis Investigative Site

City

Rouen Cedex

ZIP/Postal Code

76031

Country

France

Facility Name

Novartis Investigative Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30159

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

Cottbus

ZIP/Postal Code

03042

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Erlangen

ZIP/Postal Code

91054

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22143

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22415

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22767

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

Potsdam

ZIP/Postal Code

14469

Country

Germany

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1027

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Eger

ZIP/Postal Code

3300

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

6720

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szekesfehervar

ZIP/Postal Code

8000

Country

Hungary

Facility Name

Novartis Investigative Site

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Novartis Investigative Site

City

Kfar Saba

ZIP/Postal Code

4428164

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

52621

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Novartis Investigative Site

City

Verona

State/Province

ZIP/Postal Code

37126

Country

Italy

Facility Name

Novartis Investigative Site

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novartis Investigative Site

City

Novara

ZIP/Postal Code

28100

Country

Italy

Facility Name

Novartis Investigative Site

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

ZIP/Postal Code

56126

Country

Italy

Facility Name

Novartis Investigative Site

City

Kita-gun

State/Province

Kagawa

ZIP/Postal Code

761-0793

Country

Japan

Facility Name

Novartis Investigative Site

City

Kawachinagano

State/Province

Osaka

ZIP/Postal Code

586-8521

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

162 8666

Country

Japan

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

06351

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Torreon

State/Province

Coahuila

ZIP/Postal Code

27000

Country

Mexico

Facility Name

Novartis Investigative Site

City

Metepec

State/Province

Estado De Mexico

ZIP/Postal Code

52140

Country

Mexico

Facility Name

Novartis Investigative Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44160

Country

Mexico

Facility Name

Novartis Investigative Site

City

Culiacan

State/Province

MEX

ZIP/Postal Code

80000

Country

Mexico

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Kongsvinger

ZIP/Postal Code

2212

Country

Norway

Facility Name

Novartis Investigative Site

City

Moss

ZIP/Postal Code

1538

Country

Norway

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

60-218

Country

Poland

Facility Name

Novartis Investigative Site

City

Poznan

ZIP/Postal Code

61 113

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02 118

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

04 305

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

53-224

Country

Poland

Facility Name

Novartis Investigative Site

City

Almada

ZIP/Postal Code

2801 951

Country

Portugal

Facility Name

Novartis Investigative Site

City

Braga

ZIP/Postal Code

4710243

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

1649-035

Country

Portugal

Facility Name

Novartis Investigative Site

City

Ponte de Lima

ZIP/Postal Code

4990 041

Country

Portugal

Facility Name

Novartis Investigative Site

City

Barnaul

ZIP/Postal Code

656024

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ekaterinburg

ZIP/Postal Code

620028

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kemerovo

ZIP/Postal Code

650000

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

127473

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Smolensk

ZIP/Postal Code

214019

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Elda

State/Province

Alicante

ZIP/Postal Code

03600

Country

Spain

Facility Name

Novartis Investigative Site

City

Cordoba

State/Province

Andalucia

ZIP/Postal Code

14004

Country

Spain

Facility Name

Novartis Investigative Site

City

Malaga

State/Province

Andalucia

ZIP/Postal Code

29010

Country

Spain

Facility Name

Novartis Investigative Site

City

Sevilla

State/Province

Andalucia

ZIP/Postal Code

41009

Country

Spain

Facility Name

Novartis Investigative Site

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Novartis Investigative Site

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Novartis Investigative Site

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46026

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

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novartis Investigative Site

City

Goteborg

ZIP/Postal Code

SE-413 45

Country

Sweden

Facility Name

Novartis Investigative Site

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Uppsala

ZIP/Postal Code

751 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Fribourg

ZIP/Postal Code

1708

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Novartis Investigative Site

City

Westcliff-on-Sea

State/Province

Essex

ZIP/Postal Code

SS0 0RY

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

Worthing

State/Province

West Sussex

ZIP/Postal Code

BN11 2DH

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bath

ZIP/Postal Code

BA1 3NG

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Doncaster

ZIP/Postal Code

DN2 5LT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Middlesbrough

ZIP/Postal Code

TS4 3BW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Northampton

ZIP/Postal Code

NN1 5BD

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.

IPD Sharing URL

https://clinicalstudydatarequest.com/Default.aspx

Citations:

PubMed Identifier

35305260

Citation

Merola JF, McInnes IB, Deodhar AA, Dey AK, Adamstein NH, Quebe-Fehling E, Aassi M, Peine M, Mehta NN. Effect of Secukinumab on Traditional Cardiovascular Risk Factors and Inflammatory Biomarkers: Post Hoc Analyses of Pooled Data Across Three Indications. Rheumatol Ther. 2022 Jun;9(3):935-955. doi: 10.1007/s40744-022-00434-z. Epub 2022 Mar 19.

Results Reference

derived

PubMed Identifier

34481517

Citation

Braun J, Blanco R, Marzo-Ortega H, Gensler LS, van den Bosch F, Hall S, Kameda H, Poddubnyy D, van de Sande M, Wiksten AS, Porter BO, Shete A, Richards HB, Haemmerle S, Deodhar A. Secukinumab in non-radiographic axial spondyloarthritis: subgroup analysis based on key baseline characteristics from a randomized phase III study, PREVENT. Arthritis Res Ther. 2021 Sep 4;23(1):231. doi: 10.1186/s13075-021-02613-9.

Results Reference

derived

PubMed Identifier

32770640

Citation

Deodhar A, Blanco R, Dokoupilova E, Hall S, Kameda H, Kivitz AJ, Poddubnyy D, van de Sande M, Wiksten AS, Porter BO, Richards HB, Haemmerle S, Braun J. Improvement of Signs and Symptoms of Nonradiographic Axial Spondyloarthritis in Patients Treated With Secukinumab: Primary Results of a Randomized, Placebo-Controlled Phase III Study. Arthritis Rheumatol. 2021 Jan;73(1):110-120. doi: 10.1002/art.41477. Epub 2020 Nov 24.

Results Reference

derived

Learn more about this trial

Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis

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Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis (PREVENT)

Non-radiographic Spondyloarthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

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