Back to resultsStudy to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis (INVIGORATE 2)
Primary Purpose
Psoriatic Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AIN457 6 mg/kg i.v.
Placebo
AIN457 3 mg/kg
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Active Psoriatic Arthritis, Intravenous secukinumab, PsA
Eligibility Criteria
Patients eligible for inclusion in this study have to fulfill all of the following 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 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 at screening
- Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or 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 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 16
- 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.
Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
- Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
- Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
- 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. The following wash-out periods need to be observed:
- Oral or topical retinoids- 4 weeks
- Photochemotherapy (e.g. PUVA)- 4 weeks
- Phototherapy (UVA or UVB)- 2 weeks
- Topical skin treatments (except in face, eyes, scalp and genital area during screening, only corticosteroids with mild to moderate potency)- 2 weeks
- Any intramuscular or intravenous corticosteroid treatment within 4 weeks before randomization.
- Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before randomization.
- Subjects who have previously been treated with more than 3 different TNF inhibitors (investigational or approved).
- Subjects who have ever received biologic immunomodulating agents, investigational or approved except for those targeting TNFα.
- Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
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
- 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
- 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
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AIN457 6 mg/kg - 3 mg/kg i.v.
Placebo
Arm Description
AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52).
Matching placebo from baseline to Week 16 and switch to AIN457 3mg/kg i.v. infusion every 4 weeks through Week 48 (exposure through Week 52).
Outcomes
Primary Outcome Measures
Proportion of subjects achieving American College of Rheumatology 50 (ACR50) response criteria
To demonstrate that the efficacy of i.v. secukinumab at Week 16 is superior to placebo in subjects with active psoriatic arthritis (PsA) based on the proportion of patients achieving an American College of Rheumatology 50 (ACR50) response
The ACR50 is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP)
Secondary Outcome Measures
Proportion of subjects achieving American College of Rheumatology 20 (ACR20) response
Improvement of ≥ 20% in tender and swollen joint count and ≥3 units in at least 3 of 5 domains as described in ACR50.
The ACR20 is a composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP)
Proportion of patients achieving Minimal Disease Activity (MDA) 5/7
MDA is assessed as 5 of the 7 following: ≤ 1 tender and swollen joint; entheseal count, PASI ≤ 1 or BSA ≤3%, PsA ≤ 15 and disease activity ≤ 20 (VAS) and HAQ-DI© ≤ 0.5
Proportion of subjects achieving a Psoriasis Area and Severity Index 90 (PASI90) response
Change from baseline for PASI90, 4 items measured in 4 body areas to reflect psoriasis lesional burden (Range 0-72). Higher scores represent worsening severity
Change from baseline for the PsA Disease Activity Score (PASDAS)
Change from baseline for PASDAS (Range: 0-10), with higher scores indicating worse disease activity
Change from baseline for the Health Assessment Questionnaire - Disability Index (HAQ-DI)
Change from baseline for HAQ-DI (Range: 0-3). Higher scores indicate severe disability
Change from baseline for the Short Form 36-Physical Component Summary (SF36-PCS)
Change from baseline for SF36-PCS (Range: 0-100), with higher scores indicating better health status.
Change from baseline for the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Change from baseline for FACIT-F on 0-4 response scale. Range: 0-52. Higher scores indicate better quality of life
Change from baseline for the Modified Nail Psoriasis Severity Index (mNAPSI)
7 groups of features for each fingernail (Score: 0-130). Higher scores represent worse nail disease
Proportion of subjects with dactylitis in the subset of subjects who have dactylitis at baseline
Finger size and tenderness (Range 0-20). A higher score implies worse dactylitis
Proportion of subjects with enthesitis in the subset of subjects who have enthesitis at baseline
6 enthesial sites and tenderness (Range: 0 -6). Higher count implies greater enthesitis burden
Assessment of safety and tolerability of i.v. secukinumab compared to placebo
The incidence of clinically significant abnormal laboratory values/test results and adverse, serious adverse events (by review of values outside clinically notable ranges, significant changes from Baseline or the previous visit, or values, which are considered to be non-typical in participants with underlying disease)
Full Information
NCT ID
NCT04209205
First Posted
October 30, 2019
Last Updated
April 13, 2023
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT04209205
Brief Title
Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis
Acronym
INVIGORATE 2
Official Title
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Multicenter Study of Intravenous Secukinumab to Compare Efficacy at 16 Weeks With Placebo and to Assess Safety and Tolerability up to 52 Weeks in Subjects With Active Psoriatic Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 29, 2020 (Actual)
Primary Completion Date
May 17, 2022 (Actual)
Study Completion Date
May 17, 2022 (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
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to provide up to 52 weeks of efficacy, safety and tolerability data to support registration of intravenous (i.v.) secukinumab (Initial dose of 6 mg/kg at Baseline (BSL) followed thereafter with 3 mg/kg administered every four weeks) in patients with active psoriatic arthritis (PsA) despite current or previous Non-steroidal anti-inflammatory drugs (NSAIDs), Disease-modifying antirheumatic drugs (DMARDs) and/or anti-tumor necrosis factor (TNF) therapy.
Detailed Description
This multicenter study used a randomized, double-blind, placebo-controlled, parallel-group design. A screening (SCR) period running up to 10 weeks before randomization was used to assess subject eligibility followed by a treatment period of 52 weeks.
At baseline, 381 patients with active psoriatic arthritis were randomized to one of the two treatment groups in a 1:1 randomization:
Group 1: Approximately 190 patients with active psoriatic arthritis; These patients received secukinumab 6 mg/kg i.v. at BSL, followed by the administration of secukinumab 3 mg/kg i.v. every four weeks starting at Week 4.
Group 2: Approximately 190 patients with active psoriatic arthritis; These patients received i.v. placebo at BSL and at Weeks 4, 8, and 12, followed by the administration of secukinumab 3 mg/kg i.v. every four weeks starting at Week 16.
Study consisted of 4 periods: a screening period (up to 10 weeks), treatment period 1 (total duration of 16 weeks) and treatment period 2 (total duration of 36 weeks) followed by a safety follow up period of 8 weeks after the end of treatment visit (i.e., Week 52).
Primary endpoint analysis will be performed with Week 16 data (last patient completing Treatment period 1 (Week 16). Long-term efficacy and safety assessments will be performed up to Week 52.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Active Psoriatic Arthritis, Intravenous secukinumab, PsA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This was a double-blind, randomized treatment trial.
Subjects, investigator staff, persons performing the assessments remained blinded to the identity of the treatment from the time of randomization until Week 60 database lock, using the following methods:
Randomization data were kept strictly confidential until the time of unblinding and were not accessible by anyone else involved in the study with the exception of the bioanalyst.
The identity of the treatments were concealed by the use of study treatments in the form of i.v. injection, filled with secukinumab or placebo that were identical in appearance.
Allocation
Randomized
Enrollment
381 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AIN457 6 mg/kg - 3 mg/kg i.v.
Arm Type
Experimental
Arm Description
AIN457 6 mg/kg i.v. infusion at baseline, followed by AIN457 3 mg/kg i.v. infusion every 4 weeks starting at Week 4 through Week 48 (exposure through Week 52).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo from baseline to Week 16 and switch to AIN457 3mg/kg i.v. infusion every 4 weeks through Week 48 (exposure through Week 52).
Intervention Type
Drug
Intervention Name(s)
AIN457 6 mg/kg i.v.
Other Intervention Name(s)
secukinumab
Intervention Description
AIN457 6 mg/kg delivered by i.v. infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo to AIN457 i.v. infusion
Intervention Type
Drug
Intervention Name(s)
AIN457 3 mg/kg
Other Intervention Name(s)
secukinumab
Intervention Description
AIN457 3 mg/kg delivered by i.v. infusion
Primary Outcome Measure Information:
Title
Proportion of subjects achieving American College of Rheumatology 50 (ACR50) response criteria
Description
To demonstrate that the efficacy of i.v. secukinumab at Week 16 is superior to placebo in subjects with active psoriatic arthritis (PsA) based on the proportion of patients achieving an American College of Rheumatology 50 (ACR50) response
The ACR50 is a composite measure defined as both improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP)
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Proportion of subjects achieving American College of Rheumatology 20 (ACR20) response
Description
Improvement of ≥ 20% in tender and swollen joint count and ≥3 units in at least 3 of 5 domains as described in ACR50.
The ACR20 is a composite measure defined as both improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure [most often Health Assessment Questionnaire (HAQ)], visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein (CRP)
Time Frame
Week 16
Title
Proportion of patients achieving Minimal Disease Activity (MDA) 5/7
Description
MDA is assessed as 5 of the 7 following: ≤ 1 tender and swollen joint; entheseal count, PASI ≤ 1 or BSA ≤3%, PsA ≤ 15 and disease activity ≤ 20 (VAS) and HAQ-DI© ≤ 0.5
Time Frame
Week 16
Title
Proportion of subjects achieving a Psoriasis Area and Severity Index 90 (PASI90) response
Description
Change from baseline for PASI90, 4 items measured in 4 body areas to reflect psoriasis lesional burden (Range 0-72). Higher scores represent worsening severity
Time Frame
Week 16
Title
Change from baseline for the PsA Disease Activity Score (PASDAS)
Description
Change from baseline for PASDAS (Range: 0-10), with higher scores indicating worse disease activity
Time Frame
Week 16
Title
Change from baseline for the Health Assessment Questionnaire - Disability Index (HAQ-DI)
Description
Change from baseline for HAQ-DI (Range: 0-3). Higher scores indicate severe disability
Time Frame
Week 16
Title
Change from baseline for the Short Form 36-Physical Component Summary (SF36-PCS)
Description
Change from baseline for SF36-PCS (Range: 0-100), with higher scores indicating better health status.
Time Frame
Week 16
Title
Change from baseline for the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Description
Change from baseline for FACIT-F on 0-4 response scale. Range: 0-52. Higher scores indicate better quality of life
Time Frame
Week 16
Title
Change from baseline for the Modified Nail Psoriasis Severity Index (mNAPSI)
Description
7 groups of features for each fingernail (Score: 0-130). Higher scores represent worse nail disease
Time Frame
Week 16
Title
Proportion of subjects with dactylitis in the subset of subjects who have dactylitis at baseline
Description
Finger size and tenderness (Range 0-20). A higher score implies worse dactylitis
Time Frame
Week 16
Title
Proportion of subjects with enthesitis in the subset of subjects who have enthesitis at baseline
Description
6 enthesial sites and tenderness (Range: 0 -6). Higher count implies greater enthesitis burden
Time Frame
Week 16
Title
Assessment of safety and tolerability of i.v. secukinumab compared to placebo
Description
The incidence of clinically significant abnormal laboratory values/test results and adverse, serious adverse events (by review of values outside clinically notable ranges, significant changes from Baseline or the previous visit, or values, which are considered to be non-typical in participants with underlying disease)
Time Frame
Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients eligible for inclusion in this study had to fulfill all of the following 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 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 at screening
Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or 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 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 16
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.
Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine)
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. The following wash-out periods need to be observed:
Oral or topical retinoids- 4 weeks
Photochemotherapy (e.g. PUVA)- 4 weeks
Phototherapy (UVA or UVB)- 2 weeks
Topical skin treatments (except in face, eyes, scalp and genital area during screening, only corticosteroids with mild to moderate potency)- 2 weeks
Any intramuscular or intravenous corticosteroid treatment within 4 weeks before randomization.
Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before randomization.
Subjects who have previously been treated with more than 3 different TNF inhibitors (investigational or approved).
Subjects who have ever received biologic immunomodulating agents, investigational or approved except for those targeting TNFα.
Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 or investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
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
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
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
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Novartis Investigative Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
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
Van Nuys
State/Province
California
ZIP/Postal Code
91405
Country
United States
Facility Name
Novartis Investigative Site
City
West Hills
State/Province
California
ZIP/Postal Code
91307
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
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Novartis Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Facility Name
Novartis Investigative Site
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Novartis Investigative Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
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
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Novartis Investigative Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Novartis Investigative Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
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
Saint Louis
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
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Novartis Investigative Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Novartis Investigative Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Novartis Investigative Site
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
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
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
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
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Novartis Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
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
Newport News
State/Province
Virginia
ZIP/Postal Code
23608
Country
United States
Facility Name
Novartis Investigative Site
City
Salvador
State/Province
BA
ZIP/Postal Code
40150 150
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
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1413
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Novartis Investigative Site
City
Barranquilla
State/Province
Atlantico
ZIP/Postal Code
080002
Country
Colombia
Facility Name
Novartis Investigative Site
City
Bucaramanga
State/Province
Santander
ZIP/Postal Code
0001
Country
Colombia
Facility Name
Novartis Investigative Site
City
Bogota
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Novartis Investigative Site
City
Cundinamarca
ZIP/Postal Code
111121
Country
Colombia
Facility Name
Novartis Investigative Site
City
Prague 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha 4
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Novartis Investigative Site
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
Novartis Investigative Site
City
Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
Novartis Investigative Site
City
Thessaloniki
ZIP/Postal Code
54622
Country
Greece
Facility Name
Novartis Investigative Site
City
Guatemala City
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Novartis Investigative Site
City
Guatemala
ZIP/Postal Code
01001
Country
Guatemala
Facility Name
Novartis Investigative Site
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Facility Name
Novartis Investigative Site
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395009
Country
India
Facility Name
Novartis Investigative Site
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560 079
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
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Novartis Investigative Site
City
Seremban
State/Province
Negeri Sembilan
ZIP/Postal Code
70300
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Novartis Investigative Site
City
Selangor Darul Ehsan
ZIP/Postal Code
68100
Country
Malaysia
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
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
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Novartis Investigative Site
City
Karwiany
ZIP/Postal Code
52-200
Country
Poland
Facility Name
Novartis Investigative Site
City
Krakow
ZIP/Postal Code
30 002
Country
Poland
Facility Name
Novartis Investigative Site
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02-962
Country
Poland
Facility Name
Novartis Investigative Site
City
Kemerovo
ZIP/Postal Code
650029
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Nizhny Novgorod
ZIP/Postal Code
603018
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
197022
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
Yekaterinburg
ZIP/Postal Code
620109
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Panorama
State/Province
Western Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Novartis Investigative Site
City
Stellenbosch
ZIP/Postal Code
7600
Country
South Africa
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
Bursa
State/Province
Gorukle
ZIP/Postal Code
16059
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect 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
Learn more about this trial
Study to Demonstrate the Efficacy, Safety and Tolerability of Intravenous Secukinumab up to 52 Weeks in Subjects With Active Psoriatic Arthritis
We'll reach out to this number within 24 hrs