Clinical trial NCT01155570: Special Investigation in Patients With Psoriasis Vulgaris and Psoriatic Arthritis (All Patients Investigation)
Official title: Special Investigation (All Cases Investigation in Patients With Psoriasis Vulgaris and Psoriatic Arthritis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Psoriasis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-07-02
Enrollment: 752
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who receive Humira for the treatment of psoriasis vulgaris or psoriatic arthritis

Brief summary: The survey will be conducted with regard to the following aspects of treatment with Humira (adalimumab) in patients with psoriasis vulgaris and psoriatic arthritis receiving this drug:

* unknown adverse drug reactions, especially clinically significant adverse reactions
* incidence and conditions of occurrence of adverse reactions in the clinical setting
* factors that may affect the safety and effectiveness of Humira.

Detailed description: This study was non-interventional, open-labeled, all-cases, central registration method, post marketing observational study in which Humira was prescribed for patients with psoriasis vulgaris and/or psoriatic arthritis in routine medical practice.

When investigators prescribed Humira to an eligible patient who provided informed consent, they filled out a registration form and send it to the registration center via postal mail. At the end of the 24-week observation period, an investigator filled out a case report form for each patient to describe the findings during the study period, and provided the completed form to medical representatives. Even if Humira treatment was for any reason discontinued, the investigators followed each such participant for 24 weeks after the first administration of Humira, and filled out a case report form for the participant at the end of the 24-week period.

Some participants entered this study from study NCT00647400 (M04-702), a Phase III extension study of Humira (adalimumab) in Japan.

Eligibility criteria: Inclusion Criteria:

All patients who receive Humira for the treatment of psoriasis vulgaris or psoriatic arthritis not responding to conventional treatment will be evaluated. Eligible patients should be

* those not responding to at least one type of conventional systemic treatment (including ultraviolet therapy) who have skin lesions involving 10% of body surface area or
* patients with intractable eruptions of joint signs/symptoms.

Exclusion Criteria:

Contraindications according to the Package Insert include patients who have any of the following:

* serious infections
* tuberculosis
* a history of hypersensitivity to any ingredient of Humira
* demyelinating disease or a history of demyelinating disease
* congestive cardiac failure.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs
timeFrame: From study registration through Week 24
measure: Physician's Global Assessment at Week 4
timeFrame: Week 4
measure: Physician's Global Assessment At Week 8
timeFrame: Week 8
measure: Physician's Global Assessment at Week 16
timeFrame: Week 16
measure: Physician's Global Assessment at Week 24
timeFrame: Week 24
measure: Psoriasis Area and Severity Index (PASI) at Week 16
timeFrame: Week 16
measure: Psoriasis Area and Severity Index (PASI) at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 24
timeFrame: Baseline and Week 24
measure: Dermatology Life Quality Index at Week 16
timeFrame: Week 16
measure: Dermatology Life Quality Index at Week 24
timeFrame: Week 24
measure: Pain Visual Analog Scale (VAS) at Week 4
timeFrame: Week 4
measure: Pain Visual Analog Scale (VAS) at Week 16
timeFrame: Week 16
measure: Pain Visual Analog Scale (VAS) at Week 24
timeFrame: Week 24
measure: Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 4
timeFrame: Week 4
measure: Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 16
timeFrame: Week 16
measure: Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 24
timeFrame: Week 24
measure: Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 4
timeFrame: Week 4
measure: Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 16
timeFrame: Week 16
measure: Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Physician's Overall Response Rating At Week 24
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 41606
city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 41769
city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 41810
city: Aichi
country: Japan
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city: Aichi
country: Japan
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city: Aichi
country: Japan
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city: Aichi
country: Japan
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city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 56340
city: Aichi
country: Japan
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city: Aichi
country: Japan
facility: Site Reference ID/Investigator# 67150
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country: Japan
facility: Site Reference ID/Investigator# 68627
city: Aizuwakamatsu
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country: Japan
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city: Anjo
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city: Aomori
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city: Asahikawa
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city: Ashikaga
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facility: Site Reference ID/Investigator# 80887
city: Ayabe
country: Japan
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city: Bunkyo-ku, Tokyo
country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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city: Hokkaido
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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city: Kobe
country: Japan
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country: Japan
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city: Kochi
country: Japan
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city: Kochi
country: Japan
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city: Kofu
country: Japan
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city: Komaki
country: Japan
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country: Japan
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city: Konan
country: Japan
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city: Koriyama
country: Japan
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city: Koriyama
country: Japan
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city: Koshigaya
country: Japan
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city: Kudamatsu
country: Japan
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country: Japan
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country: Japan
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city: Kurashiki
country: Japan
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city: Kurashiki
country: Japan
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city: Kurashiki
country: Japan
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city: Kurashiki
country: Japan
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city: Kurashiki
country: Japan
facility: Site Reference ID/Investigator# 60001
city: Kure
country: Japan
facility: Site Reference ID/Investigator# 41718
city: Kurobe
country: Japan
facility: Site Reference ID/Investigator# 41689
city: Kurume
country: Japan
facility: Site Reference ID/Investigator# 41460
city: Kurume
country: Japan
facility: Site Reference ID/Investigator# 56202
city: Kushiro
country: Japan
facility: Site Reference ID/Investigator# 41839
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 41454
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 41698
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 41700
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 41705
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 41768
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 41801
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 41806
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 41905
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 41921
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 56193
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 56194
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 56259
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 56344
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 60005
city: Kyoto
country: Japan
facility: Site Reference ID/Investigator# 64807
city: Maebashi
country: Japan
facility: Site Reference ID/Investigator# 41831
city: Maebashi
country: Japan
facility: Site Reference ID/Investigator# 41834
city: Maebashi
country: Japan
facility: Site Reference ID/Investigator# 56121
city: Maebashi
country: Japan
facility: Site Reference ID/Investigator# 67263
city: Maizuru
country: Japan
facility: Site Reference ID/Investigator# 59994
city: Matsumoto
country: Japan
facility: Site Reference ID/Investigator# 41900
city: Matsumoto
country: Japan
facility: Site Reference ID/Investigator# 41901
city: Matsuyama
country: Japan
facility: Site Reference ID/Investigator# 41324
city: Matsuyama
country: Japan
facility: Site Reference ID/Investigator# 41723
city: Matsuyama
country: Japan
facility: Site Reference ID/Investigator# 41902
city: MIE
country: Japan
facility: Site Reference ID/Investigator# 41308
city: Mie
country: Japan
facility: Site Reference ID/Investigator# 41749
city: Mie
country: Japan
facility: Site Reference ID/Investigator# 56208
city: Mie
country: Japan
facility: Site Reference ID/Investigator# 56255
city: Mie
country: Japan
facility: Site Reference ID/Investigator# 59996
city: Minato
country: Japan
facility: Site Reference ID/Investigator# 41608
city: Minato
country: Japan
facility: Site Reference ID/Investigator# 41794
city: Mito
country: Japan
facility: Site Reference ID/Investigator# 41760
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 41855
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 41859
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 41861
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 41865
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 41871
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 56111
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 56112
city: Miyagi
country: Japan
facility: Site Reference ID/Investigator# 56329
city: Miyazaki
country: Japan
facility: Site Reference ID/Investigator# 41475
city: Miyazaki
country: Japan
facility: Site Reference ID/Investigator# 41790
city: Miyazaki
country: Japan
facility: Site Reference ID/Investigator# 41791
city: Miyazaki
country: Japan
facility: Site Reference ID/Investigator# 41919
city: Miyazaki
country: Japan
facility: Site Reference ID/Investigator# 60021
city: Morioka
country: Japan
facility: Site Reference ID/Investigator# 41458
city: Nagakute
country: Japan
facility: Site Reference ID/Investigator# 41462
city: Nagakute
country: Japan
facility: Site Reference ID/Investigator# 41545
city: Nagano
country: Japan
facility: Site Reference ID/Investigator# 41797
city: Nagano
country: Japan
facility: Site Reference ID/Investigator# 41863
city: Nagano
country: Japan
facility: Site Reference ID/Investigator# 41866
city: Nagano
country: Japan
facility: Site Reference ID/Investigator# 41870
city: Nagano
country: Japan
facility: Site Reference ID/Investigator# 56124
city: Nagaokakyo
country: Japan
facility: Site Reference ID/Investigator# 64808
city: Nagasaki
country: Japan
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city: Nagasaki
country: Japan
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country: Japan
facility: Site Reference ID/Investigator# 41730
city: Nagasaki
country: Japan
facility: Site Reference ID/Investigator# 41736
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country: Japan
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country: Japan
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country: Japan
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city: Nagasaki
country: Japan
facility: Site Reference ID/Investigator# 41877
city: Nagoya
country: Japan
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city: Nagoya
country: Japan
facility: Site Reference ID/Investigator# 41290
city: Nagoya
country: Japan
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city: Nagoya
country: Japan
facility: Site Reference ID/Investigator# 41744
city: Nagoya
country: Japan
facility: Site Reference ID/Investigator# 41802
city: Nagoya
country: Japan
facility: Site Reference ID/Investigator# 41909
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country: Japan
facility: Site Reference ID/Investigator# 41910
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country: Japan
facility: Site Reference ID/Investigator# 56130
city: Nanao
country: Japan
facility: Site Reference ID/Investigator# 41804
city: Nankoku
country: Japan
facility: Site Reference ID/Investigator# 41478
city: Nara
country: Japan
facility: Site Reference ID/Investigator# 41710
city: Nara
country: Japan
facility: Site Reference ID/Investigator# 56091
city: Nara
country: Japan
facility: Site Reference ID/Investigator# 56227
city: Nara
country: Japan
facility: Site Reference ID/Investigator# 59985
city: Nayori
country: Japan
facility: Site Reference ID/Investigator# 80896
city: Nigata
country: Japan
facility: Site Reference ID/Investigator# 67152
city: Niigata
country: Japan
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city: Niigata
country: Japan
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city: Niigata
country: Japan
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city: Niigata
country: Japan
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city: Niigata
country: Japan
facility: Site Reference ID/Investigator# 64812
city: Nishihara
country: Japan
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city: Nishinomiya
country: Japan
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city: Nishinomiya
country: Japan
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city: Nishio
country: Japan
facility: Site Reference ID/Investigator# 80877
city: Nisshin
country: Japan
facility: Site Reference ID/Investigator# 67264
city: Obihiro
country: Japan
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country: Japan
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city: Odawara
country: Japan
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city: Ogaki
country: Japan
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country: Japan
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country: Japan
facility: Site Reference ID/Investigator# 56203
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country: Japan
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country: Japan
facility: Site Reference ID/Investigator# 41701
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country: Japan
facility: Site Reference ID/Investigator# 41702
city: Okayama
country: Japan
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city: Okayama
country: Japan
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city: Okayama
country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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city: Osaka
country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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city: Osaka
country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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country: Japan
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facility: Site Reference ID/Investigator# 60007
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facility: Site Reference ID/Investigator# 41225
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facility: Site Reference ID/Investigator# 41245
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facility: Site Reference ID/Investigator# 41444
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facility: Site Reference ID/Investigator# 41445
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facility: Site Reference ID/Investigator# 41446
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facility: Site Reference ID/Investigator# 41447
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country: Japan
facility: Site Reference ID/Investigator# 41911
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country: Japan
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country: Japan
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facility: Site Reference ID/Investigator# 41924
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country: Japan
facility: Site Reference ID/Investigator# 41925
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country: Japan
facility: Site Reference ID/Investigator# 56092
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country: Japan
facility: Site Reference ID/Investigator# 56093
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country: Japan
facility: Site Reference ID/Investigator# 56102
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country: Japan
facility: Site Reference ID/Investigator# 56104
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country: Japan
facility: Site Reference ID/Investigator# 56125
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country: Japan
facility: Site Reference ID/Investigator# 56126
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country: Japan
facility: Site Reference ID/Investigator# 56211
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country: Japan
facility: Site Reference ID/Investigator# 56225
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country: Japan
facility: Site Reference ID/Investigator# 56243
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country: Japan
facility: Site Reference ID/Investigator# 56244
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country: Japan
facility: Site Reference ID/Investigator# 56245
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country: Japan
facility: Site Reference ID/Investigator# 56246
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country: Japan
facility: Site Reference ID/Investigator# 56247
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 56248
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country: Japan
facility: Site Reference ID/Investigator# 56331
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country: Japan
facility: Site Reference ID/Investigator# 60000
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 60002
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 60008
city: Tokyo
country: Japan
facility: Site Reference ID/Investigator# 60020
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country: Japan
facility: Site Reference ID/Investigator# 80885
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country: Japan
facility: Site Reference ID/Investigator# 80888
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country: Japan
facility: Site Reference ID/Investigator# 41787
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country: Japan
facility: Site Reference ID/Investigator# 67142
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country: Japan
facility: Site Reference ID/Investigator# 56262
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country: Japan
facility: Site Reference ID/Investigator# 41325
city: Toyama
country: Japan
facility: Site Reference ID/Investigator# 41609
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country: Japan
facility: Site Reference ID/Investigator# 41685
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country: Japan
facility: Site Reference ID/Investigator# 41688
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country: Japan
facility: Site Reference ID/Investigator# 41692
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country: Japan
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country: Japan
facility: Site Reference ID/Investigator# 56097
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country: Japan
facility: Site Reference ID/Investigator# 56192
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country: Japan
facility: Site Reference ID/Investigator# 56258
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country: Japan
facility: Site Reference ID/Investigator# 60004
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country: Japan
facility: Site Reference ID/Investigator# 64806
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country: Japan
facility: Site Reference ID/Investigator# 41288
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country: Japan
facility: Site Reference ID/Investigator# 60010
city: Toyoake
country: Japan
facility: Site Reference ID/Investigator# 67147
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country: Japan
facility: Site Reference ID/Investigator# 41307
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country: Japan
facility: Site Reference ID/Investigator# 41845
city: Toyooka
country: Japan
facility: Site Reference ID/Investigator# 56228
city: Toyota
country: Japan
facility: Site Reference ID/Investigator# 56089
city: Tsukuba
country: Japan
facility: Site Reference ID/Investigator# 56114
city: Tsukuba
country: Japan
facility: Site Reference ID/Investigator# 56115
city: Tsuyama
country: Japan
facility: Site Reference ID/Investigator# 56204
city: Uji
country: Japan
facility: Site Reference ID/Investigator# 56210
city: Urayasu
country: Japan
facility: Site Reference ID/Investigator# 41453
city: Urayasu
country: Japan
facility: Site Reference ID/Investigator# 41759
city: Utazu
country: Japan
facility: Site Reference ID/Investigator# 41807
city: Utazu
country: Japan
facility: Site Reference ID/Investigator# 41923
city: Utsunomiya
country: Japan
facility: Site Reference ID/Investigator# 80913
city: Wakayama
country: Japan
facility: Site Reference ID/Investigator# 41463
city: Wakayama
country: Japan
facility: Site Reference ID/Investigator# 41677
city: Wakayama
country: Japan
facility: Site Reference ID/Investigator# 41681
city: Wakayama
country: Japan
facility: Site Reference ID/Investigator# 41770
city: Yachiyo
country: Japan
facility: Site Reference ID/Investigator# 80890
city: Yachiyo
country: Japan
facility: Site Reference ID/Investigator# 80891
city: Yachiyo
country: Japan
facility: Site Reference ID/Investigator# 80894
city: Yamagata
country: Japan
facility: Site Reference ID/Investigator# 41894
city: Yamagata
country: Japan
facility: Site Reference ID/Investigator# 41895
city: Yamagata
country: Japan
facility: Site Reference ID/Investigator# 41898
city: Yamagata
country: Japan
facility: Site Reference ID/Investigator# 56110
city: Yamagata
country: Japan
facility: Site Reference ID/Investigator# 56328
city: Yamaguchi
country: Japan
facility: Site Reference ID/Investigator# 41711
city: Yamaguchi
country: Japan
facility: Site Reference ID/Investigator# 41722
city: Yamaguchi
country: Japan
facility: Site Reference ID/Investigator# 41726
city: Yamaguchi
country: Japan
facility: Site Reference ID/Investigator# 56199
city: Yamaguchi
country: Japan
facility: Site Reference ID/Investigator# 56223
city: Yamanashi
country: Japan
facility: Site Reference ID/Investigator# 41899
city: Yatomi
country: Japan
facility: Site Reference ID/Investigator# 41297
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 41275
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 41276
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 41277
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 41285
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 41286
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 41450
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 41860
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 41916
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 56128
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 56332
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 71459
city: Yokohama
country: Japan
facility: Site Reference ID/Investigator# 80917
city: Yokosuka
country: Japan
facility: Site Reference ID/Investigator# 41291
city: Yokosuka
country: Japan
facility: Site Reference ID/Investigator# 71458
city: Yonago
country: Japan
facility: Site Reference ID/Investigator# 41706
city: Yufu
country: Japan
facility: Site Reference ID/Investigator# 41738
Study officials:
affiliation: AbbVie
name: Yuji Yamaguchi, MD
role: STUDY_DIRECTOR
References: