Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis
NCT ID: NCT01646073
Last Updated: 2015-01-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
425 participants
INTERVENTIONAL
2012-08-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Adalimumab
Adalimumab 40 mg every other week (eow)
Adalimumab
adalimumab eow
Placebo
placebo
placebo
placebo
Interventions
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Adalimumab
adalimumab eow
placebo
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have stable plaque psoriasis for at least 2 months before screening and baseline visits.
* Participant must have a Psoriasis Area Severity Index score greater than or equal to 10 at the baseline visit.
* Participant must have moderate to severe plaque Psoriasis, defined by Body Surface Area involvement greater than or equal to 10% at the baseline visit.
* Participant must have a Physicians Global Assessment of at least moderate disease at baseline visit.
Exclusion Criteria
* Participant has known hypersensitivity to adalimumab or it excipients.
* Participant has chronic recurring infections or active tuberculosis.
* Participant has demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
* Participant is known to have immune deficiency or is immunocompromised.
18 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Okun, MD
Role: STUDY_CHAIR
AbbVie
Locations
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Site Reference ID/Investigator# 72888
Beijing, , China
Site Reference ID/Investigator# 72873
Beijing, , China
Site Reference ID/Investigator# 72887
Beijing, , China
Site Reference ID/Investigator# 85693
Chengdu, , China
Site Reference ID/Investigator# 72976
Chongqing, , China
Site Reference ID/Investigator# 72880
Dalian, , China
Site Reference ID/Investigator# 72973
Guangzhou, , China
Site Reference ID/Investigator# 72974
Guangzhou, , China
Site Reference ID/Investigator# 72878
Hangzhou, Zhejiang, , China
Site Reference ID/Investigator# 72877
Hangzhou, Zhejiang, , China
Site Reference ID/Investigator# 87058
Jinan, , China
Site Reference ID/Investigator# 72876
Shanghai, , China
Site Reference ID/Investigator# 72875
Shanghai, , China
Site Reference ID/Investigator# 72883
Shenyang, , China
Site Reference ID/Investigator# 72977
Wuhan, Hubei, , China
Site Reference ID/Investigator# 72975
Xi'an, , China
Countries
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Related Links
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Related Info
Other Identifiers
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M13-606
Identifier Type: -
Identifier Source: org_study_id
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