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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02696031




Registration number
NCT02696031
Ethics application status
Date submitted
13/10/2015
Date registered
2/03/2016

Titles & IDs
Public title
Study of Efficacy and Safety of Secukinumab in Patients With Non-radiographic Axial Spondyloarthritis
Scientific title
A Randomized, Double-blind, Placebo-controlled Multicenter Study of Secukinumab 150 mg in Patients With Active nr- axSpA to Evaluate the Safety,Tolerability and Efficacy up to 2 Yrs, Followed by an Opt Phase of Either 150 mg or 300 mg Randomized Dose Escalation for up to Another 2 Yrs
Secondary ID [1] 0 0
CAIN457H2315
Universal Trial Number (UTN)
Trial acronym
PREVENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-radiographic Spondyloarthritis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Secukinumab
Treatment: Drugs - Placebo

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

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

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

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

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

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


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

Treatment: Drugs: Placebo
Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response at Week 16
Timepoint [1] 0 0
Week 16
Primary outcome [2] 0 0
The Number and Percentage of TNF Naive Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 52
Timepoint [2] 0 0
Week 52
Secondary outcome [1] 0 0
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response
Timepoint [1] 0 0
Week 16 and week 52
Secondary outcome [2] 0 0
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 20 Response
Timepoint [2] 0 0
Week 16
Secondary outcome [3] 0 0
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 5/6 Response
Timepoint [3] 0 0
Week 16
Secondary outcome [4] 0 0
The Number and Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society Partial Remission (ASAS PR)
Timepoint [4] 0 0
Week 16
Secondary outcome [5] 0 0
Change in Bath Ankylosing Spondylitis Functional Index (BASFI)
Timepoint [5] 0 0
Baseline and Week 16
Secondary outcome [6] 0 0
The Number and Percentage of Patients to Achieve a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 Response
Timepoint [6] 0 0
Week 16 and 52
Secondary outcome [7] 0 0
Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Timepoint [7] 0 0
Baseline and Week 16
Secondary outcome [8] 0 0
Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 16
Timepoint [8] 0 0
Baseline and Week 16
Secondary outcome [9] 0 0
Change in Ankylosing Spondylitis Quality of Life (ASQoL) Scores at Week 52
Timepoint [9] 0 0
Baseline and Week 52
Secondary outcome [10] 0 0
The Number and Percentage of Patients Who Achieved an Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Inactive Disease
Timepoint [10] 0 0
Week 52
Secondary outcome [11] 0 0
Change in High Sensitivity C-reactive Protein
Timepoint [11] 0 0
Baseline and Week 16
Secondary outcome [12] 0 0
Change in Short Form-36 Physical Component Summary (SF-36 PCS)
Timepoint [12] 0 0
Baseline and Week 16
Secondary outcome [13] 0 0
Change in Sacroiliac Joint Edema - Week 16
Timepoint [13] 0 0
Baseline and Week 16
Secondary outcome [14] 0 0
Change in Sacroiliac Joint Edema - Week 52
Timepoint [14] 0 0
Baseline and Week 52

Eligibility
Key inclusion criteria
* Male or non-pregnant, non-nursing female patients at least 18 years of age
* Diagnosis of axial spondyloarthritis according to Ankylosing SpondyloArthritis International Society (ASAS) axial spondyloarthritis criteria
* objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
* active axial spondyloarthritis as assessed by total Bath Ankylosing Spondylitis Disease Activity Index >=4 cm
* Spinal pain as measured by Bath Ankylosing Spondylitis Disease Activity Index question #2 = 4 cm (0-10 cm) at baseline
* Total back pain as measured by Visual Analogue scale = 40 mm (0-100 mm) at baseline
* Patients should have been on at least 2 different non-steroidal anti-inflammatory drugs with an inadequate response
* Patients who have been on a Tumor Necrosis Factor (TNF) a inhibitor (not more than one) must have experienced an inadequate response
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with radiographic evidence for sacroiliitis, grade = 2 bilaterally or grade = 3 unilaterally
* Inability or unwillingness to undergo MRI
* Chest X-ray or MRI with evidence of ongoing infectious or malignant process
* Patients taking high potency opioid analgesics
* Previous exposure to secukinumab or any other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor
* Pregnant or nursing (lactating) women

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/03/2021
Sample size
Target
Accrual to date
Final
555
Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Coffs Harbour
Recruitment hospital [2] 0 0
Novartis Investigative Site - Maroochydore
Recruitment hospital [3] 0 0
Novartis Investigative Site - Hobart
Recruitment hospital [4] 0 0
Novartis Investigative Site - Malvern East
Recruitment hospital [5] 0 0
Novartis Investigative Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
4558 - Maroochydore
Recruitment postcode(s) [3] 0 0
7000 - Hobart
Recruitment postcode(s) [4] 0 0
3145 - Malvern East
Recruitment postcode(s) [5] 0 0
QLD 4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
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Idaho
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United States of America
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Kentucky
Country [7] 0 0
United States of America
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Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Montana
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
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North Carolina
Country [11] 0 0
United States of America
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Oklahoma
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United States of America
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Oregon
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United States of America
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Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
Austria
State/province [16] 0 0
Graz
Country [17] 0 0
Austria
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Vienna
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Belgium
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Bruxelles
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Belgium
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Genk
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Belgium
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Gent
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Bulgaria
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Pleven
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Bulgaria
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Sofia
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Czechia
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Czech Republic
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Czechia
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CZE
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Czechia
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CZ
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Czechia
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Uherske Hradiste
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France
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Haute Vienne
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France
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Bordeaux Cedex
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France
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Boulogne Billancourt
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France
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Chambray les Tours
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France
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Monaco
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France
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Paris Cedex 14
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France
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Poitiers
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France
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Rouen Cedex
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Germany
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Niedersachsen
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Germany
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Berlin
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Germany
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Cottbus
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Germany
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Dresden
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Germany
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Erlangen
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Herne
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Germany
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Magdeburg
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Germany
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Potsdam
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Eger
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Hungary
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Szeged
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Hungary
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Szekesfehervar
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Hungary
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Veszprem
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Israel
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Haifa
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Israel
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Kfar Saba
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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VR
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Italy
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Bologna
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Italy
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Novara
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Italy
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Padova
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Italy
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Pisa
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Kagawa
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Jalisco
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MEX
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Netherlands
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Amsterdam
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Groningen
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Maastricht
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Norway
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Kongsvinger
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Moss
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Krakow
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Wroclaw
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Portugal
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Almada
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Braga
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Lisboa
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Portugal
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Ponte de Lima
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Barnaul
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Kemerovo
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Saratov
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Russian Federation
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Smolensk
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Spain
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Alicante
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Spain
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Andalucia
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Spain
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Barcelona
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Spain
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Cantabria
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Spain
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Comunidad Valenciana
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Spain
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Galicia
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Spain
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Pais Vasco
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Spain
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Pontevedra
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Spain
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Madrid
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Sweden
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Goteborg
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Sweden
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Lund
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Sweden
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Uppsala
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Switzerland
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Basel
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Switzerland
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Fribourg
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Turkey
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Ankara
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United Kingdom
State/province [103] 0 0
Essex
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United Kingdom
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London
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United Kingdom
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Staffordshire
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United Kingdom
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West Sussex
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United Kingdom
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Bath
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United Kingdom
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Doncaster
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United Kingdom
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Middlesbrough
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United Kingdom
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Northampton
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United Kingdom
State/province [111] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com/Default.aspx


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02696031