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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03982394




Registration number
NCT03982394
Ethics application status
Date submitted
10/06/2019
Date registered
11/06/2019
Date last updated
29/10/2020

Titles & IDs
Public title
Observational Study of Patients With Moderate to Severe Chronic Plaque Psoriasis
Scientific title
Multi-Country Prospective ObserVAtionaL, Cohort Study of Patients With Moderate to Severe Chronic PlaqUE Psoriasis (VALUE)
Secondary ID [1] 0 0
P19-377
Universal Trial Number (UTN)
Trial acronym
VALUE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Plaque Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants treated with Risankizumab - Treatment decision independently made of study enrollment

Participants treated with other approved biological therapies - Treatment decision independently made of study enrollment

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 90 - PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
Timepoint [1] 0 0
From Month 4 to 3 years
Primary outcome [2] 0 0
Time to first treatment change - Identify time to first treatment change including discontinuation, dose escalation and dosing interval shortening
Timepoint [2] 0 0
From Week 0 (Baseline) to first treatment change
Secondary outcome [1] 0 0
Time to first treatment change rate - Time to first treatment change including discontinuation, dose escalation and dose interval shortening.
Timepoint [1] 0 0
At 1 year, 2 year, and 3 year
Secondary outcome [2] 0 0
Percentage of participants who achieved Static Physicians Global Assessment (sPGA) 0/1 or sPGA 0 - The sPGA is the physician's current assessment of the average thickness, erythema, and scaling of all psoriatic lesions. sPGA scores demonstrate overall psoriatic disease with a lower score indicating less body coverage. The assessment is considered "static" which refers to the patients disease state at the time of the assessments, without comparison to any of the patient's previous disease states, whether at Baseline or at a previous visit.
Timepoint [2] 0 0
Monthly for up to 3 years
Secondary outcome [3] 0 0
Percentage of participants who achieved Psoriasis Area and Severity Index (PASI) 75, 90, or 100 - PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. Each threshold will be analyzed separately.
Timepoint [3] 0 0
Monthly for up to 3 years
Secondary outcome [4] 0 0
Percentage of participants who achieved Absolute PASI<=5, <=3 or <=1 - Used to assess the benefit of psoriasis therapy. Each threshold will be analyzed separately.
Timepoint [4] 0 0
Monthly for up to 3 years
Secondary outcome [5] 0 0
Time to achieve sPGA 0/1 or sPGA 0 - The sPGA is the assessment by the Investigator of the overall disease severity at the time of evaluation. The National Psoriasis Foundation Psoriasis Score version of a static PGA is calculated by averaging the total body erythema, induration, and desquamation scores.
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [6] 0 0
Time to achieve PASI 75, 90,or 100 - PASI 75, 90, or 100 defined as at least a 75%/ 90%/ 100% reduction in PASI relative to Week 0 (Baseline). Each threshold will be analyzed separately.
Timepoint [6] 0 0
Up to 3 years
Secondary outcome [7] 0 0
Percentage of participants who achieve sPGA 0/1 or sPGA 0 at 4 Months and maintained the response status at 1 Year, 2 Years and 3 Years without increasing the dose or shortening the dose interval - Percentage of participants who achieve sPGA 0/1 or sPGA 0 at 4 Months and maintained the response status at 1 Year, 2 Years and 3 Years without increasing the dose or shortening the dose interval.
Timepoint [7] 0 0
At 4 months to 1 year, 2 years, and 3 years
Secondary outcome [8] 0 0
Percentage of participants who achieved PASI 90 or PASI 100 at 4 Months and maintained the response status at 1 Year, 2 Years, and 3 Years without changing the indicated dose or dosing interval - Percentage of participants who achieved PASI 90 or PASI 100 demonstrating a 90 or 100% reduction in PASI at 4 Months and maintained the response status at 1 Year, 2 Years, and 3 Years without changing the indicated dose or dosing interval.
Timepoint [8] 0 0
At 4 months and 1 year, 2 years, and 3 years
Secondary outcome [9] 0 0
Change in PASI - PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination.
Timepoint [9] 0 0
From Week 0 to up to 3 years
Secondary outcome [10] 0 0
Change in Body Surface Area (BSA) - BSA can be used to quantify the severity of psoriasis. A decrease in BSA affected by psoriasis indicates improvement.
Timepoint [10] 0 0
From Week 0 to up to 3 years
Secondary outcome [11] 0 0
Change in Dermatology Quality of Life Index (DLQI) Score - The Dermatology Life Quality Index (DLQI) is the most commonly used quality of life (QoL) assessment tool. The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status. Scores range from 0 (not relevant/not at all) to 3 (very much).
Timepoint [11] 0 0
From Week 0 to up to 3 years
Secondary outcome [12] 0 0
Percentage of participants who achieve DLQI 0/1 - The Dermatology Life Quality Index (DLQI) is the most commonly used quality of life (QoL) assessment tool. The DLQI is a self-administered, ten-question questionnaire used to assess the effect of different skin diseases on a subject's quality of life, overall health, and disability status. The higher the DLQI score, the more quality of life is impaired.
Timepoint [12] 0 0
Monthly for up to 3 years
Secondary outcome [13] 0 0
Change in Treatment Satisfaction Questionnaire for Medication (TSQM) score - The Treatment Satisfaction Questionnaire for Medication (TSQM) is a widely used generic measure to assess treatment satisfaction with their medication. This is a 100-point scale with higher scores indicating greater satisfaction with medication and provides scores on four scales - side effects, effectiveness, convenience and global satisfaction.
Timepoint [13] 0 0
From Week 0 to up to 3 years

Eligibility
Key inclusion criteria
- Confirmed diagnosis of moderate to severe chronic plaque-type psoriasis diagnosed by a
specialist and presence of moderate to severe psoriasis symptoms according to
physician's judgement at time of recruitment.

- Participant starting any approved treatment for psoriasis and physician's decision
must be reached prior to recruitment in the study.

- Participant willing to continue with study documentation after cessation of therapy.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unwillingness or inability to comply with study requirements.

- Participation in an interventional clinical trial, concurrently or within the last 30
days. Participation in a post-market observational study (PMOS) or Registry is
acceptable.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Premier Specialists /ID# 218158 - Kogarah
Recruitment hospital [2] 0 0
Kingsway Dermatology & Aesthetics /ID# 217616 - Miranda
Recruitment hospital [3] 0 0
Northern Dermatology /ID# 218374 - Chermside
Recruitment hospital [4] 0 0
Veracity Clinical Research /ID# 217618 - Woolloongabba
Recruitment hospital [5] 0 0
Skin Health Institute Inc /ID# 217619 - Carlton
Recruitment hospital [6] 0 0
Fremantle Dermatology /ID# 217617 - Fremantle
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2228 - Miranda
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment postcode(s) [6] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciuadad Autonoma De Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Caba
Country [4] 0 0
Argentina
State/province [4] 0 0
Ciudad Autonoma Buenos Aires
Country [5] 0 0
Argentina
State/province [5] 0 0
Lomas de Zamora
Country [6] 0 0
Argentina
State/province [6] 0 0
Pilar
Country [7] 0 0
Austria
State/province [7] 0 0
Wien
Country [8] 0 0
Austria
State/province [8] 0 0
Feldkirch
Country [9] 0 0
Austria
State/province [9] 0 0
Wels
Country [10] 0 0
Canada
State/province [10] 0 0
Alberta
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Manitoba
Country [13] 0 0
Canada
State/province [13] 0 0
New Brunswick
Country [14] 0 0
Canada
State/province [14] 0 0
Newfoundland and Labrador
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Colombia
State/province [17] 0 0
Cundinamarca
Country [18] 0 0
Colombia
State/province [18] 0 0
Distrito Capital De Bogota
Country [19] 0 0
Colombia
State/province [19] 0 0
Bogota
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Colombia
State/province [20] 0 0
Bogotá
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Colombia
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Medellin
Country [22] 0 0
Colombia
State/province [22] 0 0
Medellín
Country [23] 0 0
Colombia
State/province [23] 0 0
Soledad - Atlantico
Country [24] 0 0
Czechia
State/province [24] 0 0
Hradec Kralove
Country [25] 0 0
Czechia
State/province [25] 0 0
Praha 1
Country [26] 0 0
Czechia
State/province [26] 0 0
Praha 5
Country [27] 0 0
Czechia
State/province [27] 0 0
Olomouc
Country [28] 0 0
Czechia
State/province [28] 0 0
Ceské Budejovice 1
Country [29] 0 0
France
State/province [29] 0 0
Bretagne
Country [30] 0 0
France
State/province [30] 0 0
Deux-Sevres
Country [31] 0 0
France
State/province [31] 0 0
Hautes-Pyrenees
Country [32] 0 0
France
State/province [32] 0 0
Ile-de-France
Country [33] 0 0
France
State/province [33] 0 0
Somme
Country [34] 0 0
France
State/province [34] 0 0
Yonne
Country [35] 0 0
France
State/province [35] 0 0
Aix En Provence
Country [36] 0 0
France
State/province [36] 0 0
Angers
Country [37] 0 0
France
State/province [37] 0 0
Boulogne Billancourt
Country [38] 0 0
France
State/province [38] 0 0
Brest
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France
State/province [39] 0 0
Caen Cedex 9
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France
State/province [40] 0 0
Chalons en Champagne
Country [41] 0 0
France
State/province [41] 0 0
Chambery
Country [42] 0 0
France
State/province [42] 0 0
Grenoble
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France
State/province [43] 0 0
Lorient
Country [44] 0 0
France
State/province [44] 0 0
Saint Mande
Country [45] 0 0
France
State/province [45] 0 0
SAINT-ETIENNE Cedex 1
Country [46] 0 0
Germany
State/province [46] 0 0
Baden-Wuerttemberg
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Germany
State/province [47] 0 0
Bayern
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State/province [48] 0 0
Rheinland-Pfalz
Country [49] 0 0
Germany
State/province [49] 0 0
Schleswig-Holstein
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Andernach
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Augsburg
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Bad Soden am Taunus
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State/province [53] 0 0
Bergen
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State/province [54] 0 0
Berlin
Country [55] 0 0
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Bielefeld
Country [56] 0 0
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Blaubeuren
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Bogen
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Borna
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Bramsche
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Bremen
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Buxtehude
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Darmstadt
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Deggendorf
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Dessau-rosslau
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Dresden
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Dueren
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Essen
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Freising
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Gelsenkirchen
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Gera
Country [71] 0 0
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Gernsbach
Country [72] 0 0
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Giessen
Country [73] 0 0
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Gießen
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Gladbeck
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Hamburg
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Hannover
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Jena
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State/province [81] 0 0
Karlsruhe
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Krefeld
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Kulmbach
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Langenau
Country [86] 0 0
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Leipzig
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Loehne
Country [88] 0 0
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State/province [88] 0 0
Luedenscheid
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State/province [89] 0 0
Magdeburg
Country [90] 0 0
Germany
State/province [90] 0 0
Mainz
Country [91] 0 0
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State/province [91] 0 0
Memmingen
Country [92] 0 0
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State/province [92] 0 0
Mönchengladbach
Country [93] 0 0
Germany
State/province [93] 0 0
Neuwied
Country [94] 0 0
Germany
State/province [94] 0 0
Nuremberg
Country [95] 0 0
Germany
State/province [95] 0 0
Osnabrueck
Country [96] 0 0
Germany
State/province [96] 0 0
Remscheid
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Germany
State/province [97] 0 0
Schwelm
Country [98] 0 0
Germany
State/province [98] 0 0
Schwerin
Country [99] 0 0
Germany
State/province [99] 0 0
Soest
Country [100] 0 0
Germany
State/province [100] 0 0
Stuttgart
Country [101] 0 0
Germany
State/province [101] 0 0
Ueberlingen
Country [102] 0 0
Germany
State/province [102] 0 0
Waltershausen
Country [103] 0 0
Germany
State/province [103] 0 0
Werdau
Country [104] 0 0
Germany
State/province [104] 0 0
Wiesbaden
Country [105] 0 0
Germany
State/province [105] 0 0
Witten
Country [106] 0 0
Germany
State/province [106] 0 0
Wolfenbuettel
Country [107] 0 0
Hungary
State/province [107] 0 0
Vas
Country [108] 0 0
Hungary
State/province [108] 0 0
Debrecen
Country [109] 0 0
Hungary
State/province [109] 0 0
Pecs
Country [110] 0 0
Hungary
State/province [110] 0 0
Szeged
Country [111] 0 0
Italy
State/province [111] 0 0
Campania
Country [112] 0 0
Italy
State/province [112] 0 0
Milano
Country [113] 0 0
Italy
State/province [113] 0 0
Ancona
Country [114] 0 0
Italy
State/province [114] 0 0
Bari
Country [115] 0 0
Italy
State/province [115] 0 0
Brescia
Country [116] 0 0
Italy
State/province [116] 0 0
Catania
Country [117] 0 0
Italy
State/province [117] 0 0
Catanzaro
Country [118] 0 0
Italy
State/province [118] 0 0
Florence
Country [119] 0 0
Italy
State/province [119] 0 0
Genoa
Country [120] 0 0
Italy
State/province [120] 0 0
L'Aquila
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Italy
State/province [121] 0 0
Milan
Country [122] 0 0
Italy
State/province [122] 0 0
Naples
Country [123] 0 0
Italy
State/province [123] 0 0
Padua
Country [124] 0 0
Italy
State/province [124] 0 0
Perugia
Country [125] 0 0
Italy
State/province [125] 0 0
Pisa
Country [126] 0 0
Italy
State/province [126] 0 0
Reggio Calabria
Country [127] 0 0
Italy
State/province [127] 0 0
Rome
Country [128] 0 0
Italy
State/province [128] 0 0
Terracina
Country [129] 0 0
Italy
State/province [129] 0 0
Vicenza
Country [130] 0 0
Japan
State/province [130] 0 0
Hokkaido
Country [131] 0 0
Japan
State/province [131] 0 0
Tochigi
Country [132] 0 0
Japan
State/province [132] 0 0
Tokyo
Country [133] 0 0
Netherlands
State/province [133] 0 0
Gelderland
Country [134] 0 0
Netherlands
State/province [134] 0 0
Alkmaar
Country [135] 0 0
Netherlands
State/province [135] 0 0
Leeuwarden
Country [136] 0 0
Romania
State/province [136] 0 0
Bucuresti
Country [137] 0 0
Romania
State/province [137] 0 0
Bucharest
Country [138] 0 0
Romania
State/province [138] 0 0
Iasi
Country [139] 0 0
Saudi Arabia
State/province [139] 0 0
Makkah
Country [140] 0 0
Saudi Arabia
State/province [140] 0 0
Riyadh
Country [141] 0 0
Switzerland
State/province [141] 0 0
Sankt Gallen
Country [142] 0 0
Switzerland
State/province [142] 0 0
Basel
Country [143] 0 0
Switzerland
State/province [143] 0 0
Bern
Country [144] 0 0
Switzerland
State/province [144] 0 0
Obbuergen
Country [145] 0 0
Switzerland
State/province [145] 0 0
Uster
Country [146] 0 0
Switzerland
State/province [146] 0 0
Zurich
Country [147] 0 0
United Arab Emirates
State/province [147] 0 0
Abu Dhabi
Country [148] 0 0
United Kingdom
State/province [148] 0 0
England
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Airdire
Country [150] 0 0
United Kingdom
State/province [150] 0 0
Belfast
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United Kingdom
State/province [151] 0 0
Bridgend
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State/province [152] 0 0
Camberley
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United Kingdom
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Cambridge
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United Kingdom
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Dudley
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London
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United Kingdom
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Manchester
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Newcastle Upon Tyne
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United Kingdom
State/province [158] 0 0
Norfolk

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the use of risankizumab in adult patients with moderate to severe
chronic plaque psoriasis and compare risankizumab to other commonly used biologics.
Trial website
https://clinicaltrials.gov/show/NCT03982394
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AbbVie Inc.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Stacy Flannery
Address 0 0
Country 0 0
Phone 0 0
847-937-9573
Fax 0 0
Email 0 0
stacy.flannery@abbvie.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03982394