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Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis (FUTURE5)

Primary Purpose

Psoriatic Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Secukinumab

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic Arthritis, Arthritis, Psoriatic, Psoriatic Arthropathy, Spondylitis

Eligibility Criteria

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

Inclusion Criteria:

Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at BSL ≥3 tender joints out of 78 and ≥3 swollen joints out of 76 (dactylitis of a digit counts as one joint each).

Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies negative at screening.
Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a documented history of plaque psoriasis.
Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs.-Subjects who are regularly taking NSAIDs as part of their PsA therapy are required to be on a stable dose for at least 2 weeks before study randomization and should remain on a stable dose up to Week 24.
Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week 24.
Subjects taking MTX (≤ 25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization and should remain on a stable dose up to Week 52.
Subjects on MTX must be on folic acid supplementation at randomization.
Subjects who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed.
Subjects who have been on a TNFα inhibitor must have experienced an inadequate response to previous or current treatment with a TNFα inhibitor given at an approved dose for at least 3 months or have stopped treatment due to safety/tolerability problems after at least one administration of a TNFα inhibitor.
Subjects who have previously been treated with TNFα inhibitors (investigational or approved) will be allowed entry into study after appropriate wash-out period prior to randomization

Exclusion Criteria:

Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process. - Subjects taking high potency opioid analgesics.

Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor. - Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization.
Any intramuscular or intravenous or intra-articular corticosteroid treatment within 4 weeks before randomization.
Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα (investigational or approved).
Previous treatment with any cell-depleting therapies including but not limited to anti- CD20, investigational agents
Other protocol-defined exclusion criteria do apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Secukinumab 150 mg load (Group 1)

Secukinumab 150 mg no load (Group 2)

Secukinumab 300 mg load (Group 3)

Placebo arm 1 (Group 4)

Placebo arm 2 (Group 4)

Arm Description

Secukinumab 150 mg sc injection every week for 4 weeks followed by Secukinumab 150 mg every 4 weeks until week 100 Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks until week 100

Secukinumab 150 mg sc injection every 4 weeks until week 100 Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks.

Secukinumab 300 mg sc injection every week for 4 weeks followed by Secukinumab 300 mg every 4 weeks until week 100

Placebo to Secukinumab sc injection every week for 4 weeks followed by placebo to Secukinumab every 4 weeks until week 16. Non-responders will be switched to Secukinumab either 150 or 300 mg sc injection every four weeks until week 100. Responders at week 16 continued receiving placebo until week 24, then were switched to secukinumab 150 or 300 mg sc injection every 4 weeks until week 100. PLEASE NOTE: Placebo arms 1 and 2 belong to the same placebo group (group 4) Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks.

Placebo to Secukinumab sc injection every week for 4 weeks followed by placebo to Secukinumab every 4 weeks until week 16. Non-responders were switched to Secukinumab either 150 or 300 mg sc injection every four weeks until week 100. Responders at week 16 continued receiving placebo until week 24, then were switched to secukinumab 150 or 300 mg sc injection every 4 weeks until week 100. PLEASE NOTE: Placebo arms 1 and 2 belong to the same placebo group (group 4) Beginning at Week 52, for subjects whose signs and symptoms were not fully controlled, and who the investigator believed may improve further with an increase in dose, may have had the secukinumab dose increased to 300mg s.c. every 4 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16

ACR20 response was defined as having a positive clinical response to treatment (individual improvement) in disease activity if the participant had at least 20% improvement based on tender 78-joint count, swollen 76-joint count and at least 20% improvement in 3 of the following 5 measures: participant's assessment of PsA pain, patient's global assessment of disease activity, physician's global assessment of disease activity, participant's self-assessed disability (Health Assessment Questionnaire Disability Index (HAQ-DI) score), and acute phase reactant evaluated as (high sensitivity c-reactive protein (hsCRP) or erythrocyte sedimentation rate (ESR)).

Secondary Outcome Measures

Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS))

PsA modified vdH-mTSS scoring method was used to assess bone erosion & joint space narrowing (JSN) in hands & feet; that included the 2nd through 5th distal interphalangeal (DIP) joints of each hand. Maximum score for erosions was 5 in joints of the hands and 10 in joints of the feet with 0=no erosions, 1=discrete erosion, 2=large erosion not passing the mid-line, and 3=large erosion passing the mid-line. JSN is: 0=normal, 1=asymmetrical or minimal narrowing up to a maximum of 25%, 2 = definite narrowing with loss of up to 50% of the normal space, 3 = definite narrowing with loss of 50-99% of the normal space, and 4 = absence of a joint space. Maximum erosion score is 320 (200 for the hands and 120 for the feet), and the max total JSN score is 208 (160 for the hands and 48 for the feet). Total radiographic score (hands & feet combined) ranges from 0 to 528, where higher scores indicate more articular damage

Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 75 (PASI75) Response

The efficacy of secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo based on the proportion of patients achieving Psoriatic Area and Severity Index 75 (PASI75) response.

Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 90 (PASI90) Response

Count and Percentage of Patients Achieving an ACR50 Response

ACR 50 Response is a measure based on American College of Rheumatology criteria of at least a 50% improvement in the number of tender and swollen joints, and a 50% improvement in at least 3 of the following: the patient's global assessment of disease status; the patient's assessment of pain; the patient's assessment of function measured using the Stanford Health Assessment Questionnaire the physician's global assessment of disease status; serum C-reactive protein levels.

Change From Baseline in HAQ-DI© Score

The change (within treatment) on secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen), at Week 16 compared with placebo for the disease activity assessed by the changes in The Health Assessment Questionnaire disability index (HAQ-DI) relative to baseline.

Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing High Sensitivity C-Reactive Protein (hsCRP))

The improvement on secukinumab 150 mg (with or without loading regimen), or 300 mg (with loading regimen) at Week 16 compared with placebo for the disease activity assessed by the changes in Disease Activity Score for 28 joints (DAS28-CRP) (utilizing High sensitivity C-Reactive Protein (hsCRP)) relative to baseline. Scores range from 0 (no difficulty) to 3 (unable to do)

Count and Percentage of Patients With Enthesitis in the Subset of Patients Who Had Enthesitis at Baseline

The efficacy of secukinumab pooled regimen (150 mg with or without loading regimen, and 300 mg with loading regimen) at Week 16 compared with placebo based on the proportion of patients with enthesitis in the subset of patients who had enthesitis at baseline

Count and Percentage of Participants With Dactylitis in the Subset of Patients Who Have Dactylitis at Baseline

The efficacy of secukinumab pooled regimen (150 mg with or without loading regimen, and 300 mg with loading regimen) at Week 16 compared with placebo based on the proportion of patients with dactylitis in the subset of patients who have dactylitis at baseline

Full Information

NCT ID

NCT02404350

First Posted

March 16, 2015

Last Updated

April 9, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02404350

Brief Title

Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis

Acronym

FUTURE5

Official Title

A Phase III, Randomized, Double-blind, Placebo Controlled Multi-center Study of Subcutaneous Secukinumab (150 mg and 300 mg) in Prefilled Syringe to Demonstrate Efficacy (Including Inhibition of Structural Damage), Safety, and Tolerability up to 2 Years in Subjects With Active Psoriatic Arthritis (FUTURE 5)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

August 31, 2015 (Actual)

Primary Completion Date

August 16, 2017 (Actual)

Study Completion Date

January 24, 2019 (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 efficacy including effect on inhibition of progression of structural damage, safety and tolerability up to 2 years with primary focus at Week 16 (week 24 for structural damage), to support the use of secukinumab pre-filled syringe (PFS) by subcutaneous (s.c.) self-administration with or without loading regimen in subjects with active Psoriatic Arthritis (PsA) despite current or previous NSAID, DMARD therapy and/or previous anti-TNFα therapy. Long term efficacy up to 2 years was based on signs and symptoms of joint/bone structure preservation (X-ray) and improvement in physical function measured by Health Assessment Questionnaire - Disability Index (HAQ-DI©), as well as skin and nail improvement for psoriasis signs.

Detailed Description

This multicenter study uses a randomized, double-blind, placebo-controlled, parallel-group design. A screening period (SCR) running up to 10 weeks before randomization will be used to assess subject eligibility followed by 104 weeks of treatment. At BSL approximately 990 subjects whose eligibility is confirmed will be randomized to one of four treatment groups in 2:2:2:3 ratio: Group 1 - secukinumab 150 mg s.c. without loading regimen Group 2 - secukinumab 150 mg s.c. with loading dose regimen Group 3 - secukinumab 300 mg s.c. with loading dose regimen Group 4 - Placebo s.c. NOTE: Group 4 is split into 2 treatment arms, detailed description below. At randomization, subjects will be stratified on the basis of previous anti-TNF therapy as TNFα inhibitor naïve (TNF-naïve) or TNFα inhibitor inadequate responders (TNF-IR). At each study treatment visit, one (for secukinumab 150 mg) or two (for secukinumab 300 mg) s.c. injections in the form of PFS will be administered, since secukinumab is available in 1.0 mL (150 mg) PFSs. Placebo to secukinumab is also available in 1.0 mL to match the active drug. At Week 16, subjects who have been randomized to secukinumab groups at BSL (Groups 1-3) will be classified as either responders (≥20% improvement from BSL in both tender joint count (TJC) and swollen joint counts (SJC)) or non-responders (<20% improvement from BSL TJC or SJC), however they will continue on the same treatment irrespective of their response status. At Week 16, subjects who have been randomized to placebo at BSL (Group 4) will be classified as either responders (≥20% improvement from BSL in both TJC and SJC) or non-responders (<20% improvement from BSL TJC or SJC): Subjects who are non-responders will receive either secukinumab 150 mg or 300 mg s.c. every 4 weeks starting at Week 16 (as dictated by treatment sequence assigned to these subjects at BSL). Subjects who are responders will continue to receive placebo every 4 weeks. Starting Week 24, these subjects will receive either secukinumab 150 mg s.c. or 300 mg s.c. every 4 weeks starting at Week 24 (as dictated by treatment sequence assigned to these subjects at BSL). At Week 24, the assessments to address the primary objective will be performed. As described above, subjects who are still receiving placebo s.c. injection will receive either secukinumab 150 mg s.c. or 300 mg s.c. every 4 weeks starting at Week 24 (as dictated by treatment sequence assigned to these subjects at BSL). At week 52, based on Investigator's decision, the subjects on a 150 mg dose whose signs and symptoms do not show satisfactory response have the possibility to be allocated to secukinumab 300 mg s.c. After the Week 52 database lock and analyses have been completed, site personnel and subjects will be unblinded to the original randomized treatment (sequence) assignment at randomization. In addition, treatment will be given open-label in order to eliminate the placebo injection. The subject will continue to receive the same active dose of secukinumab as open-label treatment administered until Week 100.

6. Conditions and Keywords

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

Psoriatic Arthritis

Keywords

Psoriatic Arthritis, Arthritis, Psoriatic, Psoriatic Arthropathy, Spondylitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

997 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Secukinumab 150 mg load (Group 1)

Arm Type

Experimental

Arm Description

Arm Title

Secukinumab 150 mg no load (Group 2)

Arm Type

Experimental

Arm Description

Arm Title

Secukinumab 300 mg load (Group 3)

Arm Type

Experimental

Arm Description

Secukinumab 300 mg sc injection every week for 4 weeks followed by Secukinumab 300 mg every 4 weeks until week 100

Arm Title

Placebo arm 1 (Group 4)

Arm Type

Placebo Comparator

Arm Description

Arm Title

Placebo arm 2 (Group 4)

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Secukinumab

Other Intervention Name(s)

AIN457

Intervention Description

Anti IL-17a monoclonal antibody

Primary Outcome Measure Information:

Title

Percentage of Participants With Active Psoriatic Arthritis (PsA) Achieving an American College of Rheumatology Response 20 (ACR20) at Week 16

Description

Time Frame

Week 16

Secondary Outcome Measure Information:

Title

Change From Baseline to Week 24 With Secukinumab Compared With Placebo for Joint/Bone Structural Damage (Using Van Der Heijde Modified Total Sharp Score (mTSS))

Description

Time Frame

Baseline, Week 24

Title

Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 75 (PASI75) Response

Description

Time Frame

Week 16

Title

Count and Percentage of Patients Achieving Psoriatic Area and Severity Index 90 (PASI90) Response

Description

Time Frame

16 weeks

Title

Count and Percentage of Patients Achieving an ACR50 Response

Description

Time Frame

16 weeks

Title

Change From Baseline in HAQ-DI© Score

Description

Time Frame

16 weeks

Title

Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing High Sensitivity C-Reactive Protein (hsCRP))

Description

Time Frame

16 weeks

Title

Count and Percentage of Patients With Enthesitis in the Subset of Patients Who Had Enthesitis at Baseline

Description

Time Frame

16 weeks

Title

Count and Percentage of Participants With Dactylitis in the Subset of Patients Who Have Dactylitis at Baseline

Description

The efficacy of secukinumab pooled regimen (150 mg with or without loading regimen, and 300 mg with loading regimen) at Week 16 compared with placebo based on the proportion of patients with dactylitis in the subset of patients who have dactylitis at baseline

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at BSL ≥3 tender joints out of 78 and ≥3 swollen joints out of 76 (dactylitis of a digit counts as one joint each). Rheumatoid factor (RF) and anti-cyclic citrullinated peptide (anti-CCP) antibodies negative at screening. Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or a documented history of plaque psoriasis. Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization with inadequate control of symptoms or at least one dose if stopped due to intolerance to NSAIDs.-Subjects who are regularly taking NSAIDs as part of their PsA therapy are required to be on a stable dose for at least 2 weeks before study randomization and should remain on a stable dose up to Week 24. Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or equivalent for at least 2 weeks before randomization and should remain on a stable dose up to Week 24. Subjects taking MTX (≤ 25 mg/week) are allowed to continue their medication if the dose is stable for at least 4 weeks before randomization and should remain on a stable dose up to Week 52. Subjects on MTX must be on folic acid supplementation at randomization. Subjects who are on a DMARD other than MTX must discontinue the DMARD 4 weeks prior to randomization visit except for leflunomide, which has to be discontinued for 8 weeks prior to randomization unless a cholestyramine wash-out has been performed. Subjects who have been on a TNFα inhibitor must have experienced an inadequate response to previous or current treatment with a TNFα inhibitor given at an approved dose for at least 3 months or have stopped treatment due to safety/tolerability problems after at least one administration of a TNFα inhibitor. Subjects who have previously been treated with TNFα inhibitors (investigational or approved) will be allowed entry into study after appropriate wash-out period prior to randomization Exclusion Criteria: Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process. - Subjects taking high potency opioid analgesics. Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor. - Ongoing use of prohibited psoriasis treatments / medications (e.g., topical corticosteroids, UV therapy) at randomization. Any intramuscular or intravenous or intra-articular corticosteroid treatment within 4 weeks before randomization. Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα (investigational or approved). Previous treatment with any cell-depleting therapies including but not limited to anti- CD20, investigational agents Other protocol-defined exclusion criteria do apply

Facility Information:

Facility Name

Novartis Investigative Site

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Novartis Investigative Site

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

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

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33624

Country

United States

Facility Name

Novartis Investigative Site

City

Coeur d'Alene

State/Province

Idaho

ZIP/Postal Code

83814

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

Brooklyn

State/Province

New York

ZIP/Postal Code

11215

Country

United States

Facility Name

Novartis Investigative Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14623

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73102

Country

United States

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Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

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Novartis Investigative Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

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United States

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City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

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United States

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Wexford

State/Province

Pennsylvania

ZIP/Postal Code

15090

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United States

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Novartis Investigative Site

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Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

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United States

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Novartis Investigative Site

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Jackson

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Tennessee

ZIP/Postal Code

38305

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United States

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Novartis Investigative Site

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

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United States

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Novartis Investigative Site

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Mesquite

State/Province

Texas

ZIP/Postal Code

75150

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United States

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City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

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United States

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Novartis Investigative Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

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United States

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Novartis Investigative Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

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United States

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City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

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United States

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Novartis Investigative Site

City

Caba

State/Province

Buenos Aires

ZIP/Postal Code

C1221ADC

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Argentina

Facility Name

Novartis Investigative Site

City

San Miguel de Tucuman

State/Province

Tucuman

Country

Argentina

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Novartis Investigative Site

City

Tucuman

ZIP/Postal Code

4000

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Argentina

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Novartis Investigative Site

City

Graz

ZIP/Postal Code

8036

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Austria

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Novartis Investigative Site

City

Vienna

ZIP/Postal Code

1100

Country

Austria

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Novartis Investigative Site

City

Vienna

ZIP/Postal Code

A-1060

Country

Austria

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Novartis Investigative Site

City

Vienna

ZIP/Postal Code

A-1160

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Austria

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Novartis Investigative Site

City

Vancouver

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British Columbia

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V5Z 4E8

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Canada

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Victoria

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British Columbia

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V8V 3M9

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Winnipeg

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Manitoba

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R3A 1M1

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Canada

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St. John's

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Newfoundland and Labrador

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A1C 5B8

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Canada

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Sainte-Foy

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Quebec

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G1V 3M7

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Canada

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Trois-Rivieres

State/Province

Quebec

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G8Z 1Y2

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Canada

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Novartis Investigative Site

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Vitacura

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Santiago

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7640881

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Chile

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Novartis Investigative Site

City

Santiago

ZIP/Postal Code

8207257

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Chile

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Novartis Investigative Site

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Bruntal

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Czech Republic

ZIP/Postal Code

792 01

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Czechia

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Novartis Investigative Site

City

Ostrava

State/Province

Czech Republic

ZIP/Postal Code

70200

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Czechia

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Novartis Investigative Site

City

Praha 11

State/Province

Czech Republic

ZIP/Postal Code

148 00

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Czechia

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Novartis Investigative Site

City

Praha 2

State/Province

Czech Republic

ZIP/Postal Code

128 50

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Czechia

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Novartis Investigative Site

City

Praha 4

State/Province

Czech Republic

ZIP/Postal Code

140 00

Country

Czechia

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Novartis Investigative Site

City

Praha 4

State/Province

Czech Republic

ZIP/Postal Code

140 59

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Czechia

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Novartis Investigative Site

City

Uherske Hradiste

ZIP/Postal Code

686 01

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Czechia

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Novartis Investigative Site

City

Odense

ZIP/Postal Code

5000 C

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Denmark

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Novartis Investigative Site

City

Tartu

ZIP/Postal Code

50406

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Estonia

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Novartis Investigative Site

City

Hyvinkaa

ZIP/Postal Code

05800

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Finland

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Novartis Investigative Site

City

Aachen

ZIP/Postal Code

52064

Country

Germany

Facility Name

Novartis Investigative Site

City

Bad Abbach

ZIP/Postal Code

93077

Country

Germany

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Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13125

Country

Germany

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Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

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Novartis Investigative Site

City

Germering

ZIP/Postal Code

82110

Country

Germany

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Novartis Investigative Site

City

Gommern

ZIP/Postal Code

39245

Country

Germany

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Novartis Investigative Site

City

Gottingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22081

Country

Germany

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Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

22143

Country

Germany

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Novartis Investigative Site

City

Herne

ZIP/Postal Code

44649

Country

Germany

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Novartis Investigative Site

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Leipzig

ZIP/Postal Code

04103

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Germany

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Novartis Investigative Site

City

Lubeck

ZIP/Postal Code

23538

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Germany

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Novartis Investigative Site

City

Nienburg

ZIP/Postal Code

31582

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Germany

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City

Athens

State/Province

ZIP/Postal Code

115 27

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Greece

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Novartis Investigative Site

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Thessaloniki

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ZIP/Postal Code

564 29

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Greece

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Novartis Investigative Site

City

Athens

ZIP/Postal Code

115 27

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Greece

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Novartis Investigative Site

City

Athens

ZIP/Postal Code

12462

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Greece

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Novartis Investigative Site

City

Patras

ZIP/Postal Code

265 00

Country

Greece

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Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01010

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Guatemala City

ZIP/Postal Code

01011

Country

Guatemala

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

Novartis Investigative Site

City

Eger

ZIP/Postal Code

3300

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kistarcsa

ZIP/Postal Code

2143

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szekesfehervar

ZIP/Postal Code

H-8000

Country

Hungary

Facility Name

Novartis Investigative Site

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Novartis Investigative Site

City

Secunderabad

State/Province

Andhra Pradesh

ZIP/Postal Code

500003

Country

India

Facility Name

Novartis Investigative Site

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380015

Country

India

Facility Name

Novartis Investigative Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400 053

Country

India

Facility Name

Novartis Investigative Site

City

Nashik

State/Province

Maharashtra

ZIP/Postal Code

422 101

Country

India

Facility Name

Novartis Investigative Site

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411007

Country

India

Facility Name

Novartis Investigative Site

City

New Delhi

ZIP/Postal Code

110029

Country

India

Facility Name

Novartis Investigative Site

City

Dublin 4

Country

Ireland

Facility Name

Novartis Investigative Site

City

Ashkelon

ZIP/Postal Code

78278

Country

Israel

Facility Name

Novartis Investigative Site

City

Haifa

ZIP/Postal Code

343621

Country

Israel

Facility Name

Novartis Investigative Site

City

Kfar Saba

ZIP/Postal Code

4428164

Country

Israel

Facility Name

Novartis Investigative Site

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Novartis Investigative Site

City

Ramat Gan

ZIP/Postal Code

5265601

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Novartis Investigative Site

City

Brescia

State/Province

ZIP/Postal Code

25123

Country

Italy

Facility Name

Novartis Investigative Site

City

Palermo

State/Province

ZIP/Postal Code

90127

Country

Italy

Facility Name

Novartis Investigative Site

City

Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novartis Investigative Site

City

Potenza

State/Province

ZIP/Postal Code

85100

Country

Italy

Facility Name

Novartis Investigative Site

City

Udine

State/Province

ZIP/Postal Code

33100

Country

Italy

Facility Name

Novartis Investigative Site

City

Riga

State/Province

ZIP/Postal Code

LV-1005

Country

Latvia

Facility Name

Novartis Investigative Site

City

Liepaja

ZIP/Postal Code

LV 3401

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV 1002

Country

Latvia

Facility Name

Novartis Investigative Site

City

Riga

ZIP/Postal Code

LV-1038

Country

Latvia

Facility Name

Novartis Investigative Site

City

Valmiera

ZIP/Postal Code

LV-4201

Country

Latvia

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

ZIP/Postal Code

LT-45130

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Kaunas

State/Province

ZIP/Postal Code

LT-50128

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Klaipeda

ZIP/Postal Code

LT-92288

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Siauliai

ZIP/Postal Code

LT-76231

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

09310

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-07195

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Mexicali

State/Province

Baja California

ZIP/Postal Code

21100

Country

Mexico

Facility Name

Novartis Investigative Site

City

Mexico

State/Province

Distrito Federal

ZIP/Postal Code

11850

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

Merida

State/Province

Yucatan

ZIP/Postal Code

97070

Country

Mexico

Facility Name

Novartis Investigative Site

City

San Luis Potosi

ZIP/Postal Code

78200

Country

Mexico

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

Schiedam

ZIP/Postal Code

3118 JH

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Utrecht

ZIP/Postal Code

3508 GA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Manila

State/Province

Metro Manila

ZIP/Postal Code

1000

Country

Philippines

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

Chelyabinsk

ZIP/Postal Code

454000

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

620028

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Ekaterinburg

ZIP/Postal Code

620137

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Kazan

ZIP/Postal Code

420064

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

129301

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Nizhniy Novgorod

ZIP/Postal Code

603005

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Nizhny Novgorod

ZIP/Postal Code

603018

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Orenburg

ZIP/Postal Code

460018

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Rostov on Don

ZIP/Postal Code

344022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Saint-Petersburg

ZIP/Postal Code

194021

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Smolensk

ZIP/Postal Code

214019

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

St-Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Novartis Investigative Site

City

Cordoba

State/Province

Andalucia

ZIP/Postal Code

14004

Country

Spain

Facility Name

Novartis Investigative Site

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Novartis Investigative Site

City

Sant Joan Despi

State/Province

Barcelona

ZIP/Postal Code

08970

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08003

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Alicante

State/Province

Comunidad Valenciana

ZIP/Postal Code

03010

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

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

Baracaldo

State/Province

Vizcaya

ZIP/Postal Code

48903

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

SE-17176

Country

Sweden

Facility Name

Novartis Investigative Site

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Novartis Investigative Site

City

Songkhla

State/Province

Hat Yai

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Novartis Investigative Site

City

Khon Kaen

State/Province

THA

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Novartis Investigative Site

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Novartis Investigative Site

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Novartis Investigative Site

City

Truro

State/Province

Cornwall

ZIP/Postal Code

TR1 3LJ

Country

United Kingdom

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

England

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Basingstoke

State/Province

Hampshire

ZIP/Postal Code

RG24 9NA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Inverness

State/Province

Invernesshire

ZIP/Postal Code

IV2 3RE

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Salford

State/Province

Manchester

ZIP/Postal Code

M6 8HD

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

Bradford

State/Province

West Yorkshire

ZIP/Postal Code

BD5 0NA

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Bath

ZIP/Postal Code

BA1 1RL

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Dundee

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Eastbourne

ZIP/Postal Code

BN21 2UD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Glasgow

ZIP/Postal Code

G31 2ER

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Leicester

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

NW1 2BU

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

NW3 2QG

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Oxford

ZIP/Postal Code

OX3 7LD

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Portsmouth

ZIP/Postal Code

PO6 3LY

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Wigan

ZIP/Postal Code

WN6 9EP

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Ho Chi Minh

State/Province

VNM

ZIP/Postal Code

700000

Country

Vietnam

Facility Name

Novartis Investigative Site

City

Hanoi

ZIP/Postal Code

100000

Country

Vietnam

Facility Name

Novartis Investigative Site

City

Ho Chi Minh

ZIP/Postal Code

7000

Country

Vietnam

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

29550766

Citation

Mease P, van der Heijde D, Landewe R, Mpofu S, Rahman P, Tahir H, Singhal A, Boettcher E, Navarra S, Meiser K, Readie A, Pricop L, Abrams K. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis. 2018 Jun;77(6):890-897. doi: 10.1136/annrheumdis-2017-212687. Epub 2018 Mar 17.

Results Reference

result

PubMed Identifier

34795065

Citation

Pournara E, Kormaksson M, Nash P, Ritchlin CT, Kirkham BW, Ligozio G, Pricop L, Ogdie A, Coates LC, Schett G, McInnes IB. Clinically relevant patient clusters identified by machine learning from the clinical development programme of secukinumab in psoriatic arthritis. RMD Open. 2021 Nov;7(3):e001845. doi: 10.1136/rmdopen-2021-001845.

Results Reference

derived

PubMed Identifier

34330846

Citation

Mease PJ, Landewe R, Rahman P, Tahir H, Singhal A, Boettcher E, Navarra S, Readie A, Mpofu S, Delicha EM, Pricop L, van der Heijde D. Secukinumab provides sustained improvement in signs and symptoms and low radiographic progression in patients with psoriatic arthritis: 2-year (end-of-study) results from the FUTURE 5 study. RMD Open. 2021 Jul;7(2):e001600. doi: 10.1136/rmdopen-2021-001600.

Results Reference

derived

PubMed Identifier

31586420

Citation

van der Heijde D, Mease PJ, Landewe RBM, Rahman P, Tahir H, Singhal A, Boettcher E, Navarra S, Zhu X, Ligozio G, Readie A, Mpofu S, Pricop L. Secukinumab provides sustained low rates of radiographic progression in psoriatic arthritis: 52-week results from a phase 3 study, FUTURE 5. Rheumatology (Oxford). 2020 Jun 1;59(6):1325-1334. doi: 10.1093/rheumatology/kez420.

Results Reference

derived

Learn more about this trial

Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis

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Study to Demonstrate the Efficacy (Including Inhibition of Structural Damage), Safety and Tolerability up to 2 Years of Secukinumab in Active Psoriatic Arthritis (FUTURE5)

Psoriatic Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

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