Clinical trial NCT01646073: Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Adalimumab (Humira®) in Chinese Subjects With Moderate to Severe Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Keywords: Plaque Psoriasis
Psoriasis
Placebo Controlled
Skin Disease
Double Blind
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate to severe plaque psoriasis.

Detailed description: The purpose of this study is to evaluate the safety and efficacy of adalimumab and to determine how well it works in the treatment of adults with moderate to severe plaque psoriasis in the Chinese population. Psoriasis is a chronic immunologic disease characterized by marked inflammation and thickening of the epidermis that result in thick, scaly plaques involving the skin.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of psoriasis for at least 6 months.
* 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:

* Diagnosis of other active skin diseases or skin infections.
* 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.

Primary outcomes:
measure: Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period A]
timeFrame: Weeks 3 and 7
measure: Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period B]
timeFrame: Weeks 16, 19, and 24
measure: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period A]
timeFrame: Baseline to Week 12
measure: Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period B]
timeFrame: Baseline to Week 24
measure: Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period A]
timeFrame: Weeks 3, 7, and 12
measure: Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 50%, 90%, or 100% Reduction (PASI 50/90/100) Response [Period B]
timeFrame: Weeks 16, 19, and 24
measure: Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period A]
timeFrame: Baseline and Weeks 3, 7, and 12
measure: Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period B]
timeFrame: Weeks 16, 19, and 24
measure: Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period A]
timeFrame: Baseline and Weeks 3, 7, and 12
measure: Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period B]
timeFrame: Weeks 16, 19, and 24
measure: Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period A]
timeFrame: Baseline, Week 3, and Week 12
measure: Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period B]
timeFrame: Week 16 and Week 24
measure: Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period A]
timeFrame: Baseline, Week 3, and Week 12
measure: Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period B]
timeFrame: Week 16 and Week 24
measure: Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period A]
timeFrame: Baseline to Week 12
measure: Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period B]
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Site Reference ID/Investigator# 72888
city: Beijing
country: China
facility: Site Reference ID/Investigator# 72873
city: Beijing
country: China
facility: Site Reference ID/Investigator# 72887
city: Chengdu
country: China
facility: Site Reference ID/Investigator# 85693
city: Chongqing
country: China
facility: Site Reference ID/Investigator# 72976
city: Dalian
country: China
facility: Site Reference ID/Investigator# 72880
city: Guangzhou
country: China
facility: Site Reference ID/Investigator# 72973
city: Guangzhou
country: China
facility: Site Reference ID/Investigator# 72974
city: Hangzhou, Zhejiang
country: China
facility: Site Reference ID/Investigator# 72878
city: Hangzhou, Zhejiang
country: China
facility: Site Reference ID/Investigator# 72877
city: Jinan
country: China
facility: Site Reference ID/Investigator# 87058
city: Shanghai
country: China
facility: Site Reference ID/Investigator# 72876
city: Shanghai
country: China
facility: Site Reference ID/Investigator# 72875
city: Shenyang
country: China
facility: Site Reference ID/Investigator# 72883
city: Wuhan, Hubei
country: China
facility: Site Reference ID/Investigator# 72977
city: Xi'an
country: China
facility: Site Reference ID/Investigator# 72975
Study officials:
affiliation: AbbVie
name: Martin Okun, MD
role: STUDY_CHAIR
References: