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Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA) (FUTURE 1)

Primary Purpose

Psoriatic Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Secukinumab (75 mg)
Secukinumab (150 mg)
Placebo Comparator
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic arthritis, PsA, ACR, CASPAR

Eligibility Criteria

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

Inclusion criteria:

  • Male or non-pregnant, non-lactating female patients at least 18 years of age
  • Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)
  • Rheumatoid factor and anti-CCP antibodies negative
  • Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥2cm diameter or nail changes consistent with psoriasis or documented history o plaque psoriasis

Exclusion criteria:

  • Chest X-ray with evidence of ongoing infectious or malignant process
  • Subjects who have previously been treated with more than 3 different TNFα inhibitors
  • Subjects taking high potency opioid analgesics
  • Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
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  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
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  • Novartis Investigative Site
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  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

Secukinumab (75mg)

Secukinumab (150 mg)

Outcomes

Primary Outcome Measures

Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo
A patient will be considered as improved according the ACR20 criteria if she/he has at least 20 % improvement in the two following measures:Tender joint count,Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR)

Secondary Outcome Measures

Percent of Subjects Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline
A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials with end points of psoriasis
Percent of Subjects Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline
A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis
Change From Baseline in DAS28-CRP for Secukinumab 75 or 150 mg
DAS-CRP values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS-CRP below the value of 2.6 is interpreted as Remission.DAS28 the DAS-CRP uses 28 different joints for its calculation: proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2) With the above mentioned parameters, DAS-CRP is calculated as: <math>DAS-CRP=0.56 \times \sqrt{TEN28} + 0.28 \times \sqrt{SW28} + 0.36 \times \ln(CRP+1) + 0.014 \times SA+0.96</math> With: TEN28: number of joints with tenderness upon touching SW28: number of swollen joints CRP: C-reactive Protein SA: subjective assessment of disease activity by the patient during the preceding 7 days on a scale betweenn 0 and 100 ("0":no activity, "100": highest activity possible)
Change From Baseline in SF36-PCS for Secukinumab 75 or 150 mg
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Change From Baseline in HAQ-DI for Secukinumab 75 or 150 mg
HAQ-DI, assesses a patient's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The stem of each item asks over the past week "Are you able to …" perform a particular task. The patient's responses are made on a scale from zero (no disability) to three (completely disabled).
Percent of Patients Achieving ACR50 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo
ACR50 = 50 % improvement in at least 3 of the 5 measures( Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR) and 50 % improvement in the swollen and tender joint count.
Change From Baseline for Joint/Bone Structural Damage (Van Der Heijde Modified Total Sharp Score) for Secukinumab 75 and 150 mg (Pooled Doses)
Measured are 44 joints for erosions: scored 0 to 5 in hands; 0 to 10 in feet;40 joints for joint space narrowing; summed for total score by two experienced readers scored every film blinded to patient identity, treatment, sequence of film. Lower score equals better outcome. With score of zero being normal. Joint structural damage change from baseline at Week 24 using non-parametric ANCOVA, Linear extrapolation. Estimate (for the difference in mean), SE are from a non-parametric ANCOVA model with the change from baseline van der Heijde total modified Sharp score as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.
Percent of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Baseline
Percent of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline

Full Information

First Posted
July 7, 2011
Last Updated
January 5, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01392326
Brief Title
Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)
Acronym
FUTURE 1
Official Title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Psoriatic Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will assess the efficacy and safety of secukinumab in patients with active psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Psoriatic arthritis, PsA, ACR, CASPAR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
606 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Secukinumab (75mg)
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Secukinumab (150 mg)
Arm Title
Group 3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Secukinumab (75 mg)
Intervention Description
Secukinumab (75 mg)
Intervention Type
Drug
Intervention Name(s)
Secukinumab (150 mg)
Intervention Description
Secukinumab (150 mg)
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
Placebo Comparator
Primary Outcome Measure Information:
Title
Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo
Description
A patient will be considered as improved according the ACR20 criteria if she/he has at least 20 % improvement in the two following measures:Tender joint count,Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR)
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percent of Subjects Achieving a PASI75 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline
Description
A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials with end points of psoriasis
Time Frame
Week 24
Title
Percent of Subjects Achieving a PASI90 Response in the Subgroup of Subjects Who Have ≥3% Skin Involvement With Psoriasis at Baseline
Description
A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis
Time Frame
Week 24
Title
Change From Baseline in DAS28-CRP for Secukinumab 75 or 150 mg
Description
DAS-CRP values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS-CRP below the value of 2.6 is interpreted as Remission.DAS28 the DAS-CRP uses 28 different joints for its calculation: proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2) With the above mentioned parameters, DAS-CRP is calculated as: <math>DAS-CRP=0.56 \times \sqrt{TEN28} + 0.28 \times \sqrt{SW28} + 0.36 \times \ln(CRP+1) + 0.014 \times SA+0.96</math> With: TEN28: number of joints with tenderness upon touching SW28: number of swollen joints CRP: C-reactive Protein SA: subjective assessment of disease activity by the patient during the preceding 7 days on a scale betweenn 0 and 100 ("0":no activity, "100": highest activity possible)
Time Frame
Week 24
Title
Change From Baseline in SF36-PCS for Secukinumab 75 or 150 mg
Description
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame
Week 24
Title
Change From Baseline in HAQ-DI for Secukinumab 75 or 150 mg
Description
HAQ-DI, assesses a patient's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The stem of each item asks over the past week "Are you able to …" perform a particular task. The patient's responses are made on a scale from zero (no disability) to three (completely disabled).
Time Frame
Week 24
Title
Percent of Patients Achieving ACR50 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo
Description
ACR50 = 50 % improvement in at least 3 of the 5 measures( Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR) and 50 % improvement in the swollen and tender joint count.
Time Frame
Week 24
Title
Change From Baseline for Joint/Bone Structural Damage (Van Der Heijde Modified Total Sharp Score) for Secukinumab 75 and 150 mg (Pooled Doses)
Description
Measured are 44 joints for erosions: scored 0 to 5 in hands; 0 to 10 in feet;40 joints for joint space narrowing; summed for total score by two experienced readers scored every film blinded to patient identity, treatment, sequence of film. Lower score equals better outcome. With score of zero being normal. Joint structural damage change from baseline at Week 24 using non-parametric ANCOVA, Linear extrapolation. Estimate (for the difference in mean), SE are from a non-parametric ANCOVA model with the change from baseline van der Heijde total modified Sharp score as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.
Time Frame
Week 24
Title
Percent of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Baseline
Time Frame
Week 24
Title
Percent of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Male or non-pregnant, non-lactating female patients at least 18 years of age Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each) Rheumatoid factor and anti-CCP antibodies negative Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥2cm diameter or nail changes consistent with psoriasis or documented history o plaque psoriasis Exclusion criteria: Chest X-ray with evidence of ongoing infectious or malignant process Subjects who have previously been treated with more than 3 different TNFα inhibitors Subjects taking high potency opioid analgesics Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα Other protocol-defined inclusion/exclusion criteria may apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207-5710
Country
United States
Facility Name
Novartis Investigative Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Novartis Investigative Site
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Facility Name
Novartis Investigative Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Novartis Investigative Site
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Novartis Investigative Site
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Novartis Investigative Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Novartis Investigative Site
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Facility Name
Novartis Investigative Site
City
Richmond Heights
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Novartis Investigative Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Novartis Investigative Site
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Novartis Investigative Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Novartis Investigative Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
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
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Novartis Investigative Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Novartis Investigative Site
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Novartis Investigative Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Novartis Investigative Site
City
Benbrook
State/Province
Texas
ZIP/Postal Code
76126
Country
United States
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Novartis Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
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
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1419AHN
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000CFJ
Country
Argentina
Facility Name
Novartis Investigative Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S200BHD
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1417EYG
Country
Argentina
Facility Name
Novartis Investigative Site
City
Cordoba
ZIP/Postal Code
X5000EOC
Country
Argentina
Facility Name
Novartis Investigative Site
City
Cordoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Facility Name
Novartis Investigative Site
City
Cordoba
ZIP/Postal Code
X5022CPU
Country
Argentina
Facility Name
Novartis Investigative Site
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Novartis Investigative Site
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
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
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
Novartis Investigative Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
04023-900
Country
Brazil
Facility Name
Novartis Investigative Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1709
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 5B8
Country
Canada
Facility Name
Novartis Investigative Site
City
St. John
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 5E8
Country
Canada
Facility Name
Novartis Investigative Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 3R7
Country
Canada
Facility Name
Novartis Investigative Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
Novartis Investigative Site
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
Novartis Investigative Site
City
Bruntal
ZIP/Postal Code
792 01
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Zlin
ZIP/Postal Code
760 01
Country
Czech Republic
Facility Name
Novartis Investigative Site
City
Aachen
ZIP/Postal Code
52064
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91056
Country
Germany
Facility Name
Novartis Investigative Site
City
Gommern
ZIP/Postal Code
39245
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
Herne
ZIP/Postal Code
44649
Country
Germany
Facility Name
Novartis Investigative Site
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Novartis Investigative Site
City
Nürnberg
ZIP/Postal Code
90429
Country
Germany
Facility Name
Novartis Investigative Site
City
Ratingen
ZIP/Postal Code
40882
Country
Germany
Facility Name
Novartis Investigative Site
City
Zerbst
ZIP/Postal Code
39261
Country
Germany
Facility Name
Novartis Investigative Site
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Novartis Investigative Site
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
Novartis Investigative Site
City
Ramat Gan
ZIP/Postal Code
5266202
Country
Israel
Facility Name
Novartis Investigative Site
City
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Novartis Investigative Site
City
Valeggio Sul Mincio
State/Province
(vr)
ZIP/Postal Code
37067
Country
Italy
Facility Name
Novartis Investigative Site
City
Catania
State/Province
CT
ZIP/Postal Code
95100
Country
Italy
Facility Name
Novartis Investigative Site
City
Prato
State/Province
PO
ZIP/Postal Code
59100
Country
Italy
Facility Name
Novartis Investigative Site
City
Siena
State/Province
SI
ZIP/Postal Code
53100
Country
Italy
Facility Name
Novartis Investigative Site
City
Lipa City
State/Province
Batangas
ZIP/Postal Code
4217
Country
Philippines
Facility Name
Novartis Investigative Site
City
Dasmarinas
State/Province
Cavite
ZIP/Postal Code
4114
Country
Philippines
Facility Name
Novartis Investigative Site
City
Manila
State/Province
Metro Manila
ZIP/Postal Code
1003
Country
Philippines
Facility Name
Novartis Investigative Site
City
Las Pinas
ZIP/Postal Code
1740
Country
Philippines
Facility Name
Novartis Investigative Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Novartis Investigative Site
City
Manila
ZIP/Postal Code
1003
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
Quezon City
ZIP/Postal Code
1121
Country
Philippines
Facility Name
Novartis Investigative Site
City
Bialystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02-341
Country
Poland
Facility Name
Novartis Investigative Site
City
Bucharest
State/Province
District 1
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucharest
Country
Romania
Facility Name
Novartis Investigative Site
City
Cluj Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Novartis Investigative Site
City
Iasi
ZIP/Postal Code
700195
Country
Romania
Facility Name
Novartis Investigative Site
City
Ekaterinburg
ZIP/Postal Code
620028
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Kemerovo
ZIP/Postal Code
650029
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St-Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Novartis Investigative Site
City
Piestany
State/Province
Slovak Republic
ZIP/Postal Code
921 12
Country
Slovakia
Facility Name
Novartis Investigative Site
City
Lucenec
ZIP/Postal Code
98401
Country
Slovakia
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
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Novartis Investigative Site
City
London
State/Province
England
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Cannock
State/Province
Staffordshire
ZIP/Postal Code
WS11 2XY
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
Glasgow
ZIP/Postal Code
G12 8TA
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31943974
Citation
Mease PJ, Kavanaugh A, Reimold A, Tahir H, Rech J, Hall S, Geusens P, Pellet P, Delicha EM, Pricop L, Mpofu S; FUTURE 1 study group. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study. ACR Open Rheumatol. 2020 Jan;2(1):18-25. doi: 10.1002/acr2.11097. Epub 2019 Nov 14.
Results Reference
derived
PubMed Identifier
31203228
Citation
Deodhar A, Gladman DD, McInnes IB, Spindeldreher S, Martin R, Pricop L, Porter B, Safi J Jr, Shete A, Bruin G. Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis. J Rheumatol. 2020 Apr;47(4):539-547. doi: 10.3899/jrheum.190116. Epub 2019 Jun 15.
Results Reference
derived
PubMed Identifier
27696786
Citation
Kavanaugh A, Mease PJ, Reimold AM, Tahir H, Rech J, Hall S, Geusens P, Wang Z, Pricop L, Mpofu S; FUTURE-1 Study Group. Secukinumab for Long-Term Treatment of Psoriatic Arthritis: A Two-Year Followup From a Phase III, Randomized, Double-Blind Placebo-Controlled Study. Arthritis Care Res (Hoboken). 2017 Mar;69(3):347-355. doi: 10.1002/acr.23111.
Results Reference
derived
PubMed Identifier
27169431
Citation
Strand V, Mease P, Gossec L, Elkayam O, van den Bosch F, Zuazo J, Pricop L, Mpofu S; FUTURE 1 study group. Secukinumab improves patient-reported outcomes in subjects with active psoriatic arthritis: results from a randomised phase III trial (FUTURE 1). Ann Rheum Dis. 2017 Jan;76(1):203-207. doi: 10.1136/annrheumdis-2015-209055. Epub 2016 May 11.
Results Reference
derived
PubMed Identifier
26422723
Citation
Mease PJ, McInnes IB, Kirkham B, Kavanaugh A, Rahman P, van der Heijde D, Landewe R, Nash P, Pricop L, Yuan J, Richards HB, Mpofu S; FUTURE 1 Study Group. Secukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis. N Engl J Med. 2015 Oct;373(14):1329-39. doi: 10.1056/NEJMoa1412679.
Results Reference
derived

Learn more about this trial

Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)

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