- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01646073
Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis
January 14, 2015 updated by: AbbVie (prior sponsor, Abbott)
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
A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate to severe plaque psoriasis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
425
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Beijing, China, 100034
- Site Reference ID/Investigator# 72888
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Beijing, China, 100044
- Site Reference ID/Investigator# 72873
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Beijing, China, 100730
- Site Reference ID/Investigator# 72887
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Chengdu, China, 610072
- Site Reference ID/Investigator# 85693
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Chongqing, China, 400038
- Site Reference ID/Investigator# 72976
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Dalian, China, 116011
- Site Reference ID/Investigator# 72880
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Guangzhou, China, 510120
- Site Reference ID/Investigator# 72973
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Guangzhou, China, 510630
- Site Reference ID/Investigator# 72974
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Hangzhou, Zhejiang, China, 310003
- Site Reference ID/Investigator# 72878
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Hangzhou, Zhejiang, China, 310009
- Site Reference ID/Investigator# 72877
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Jinan, China, 250012
- Site Reference ID/Investigator# 87058
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Shanghai, China, 200025
- Site Reference ID/Investigator# 72876
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Shanghai, China, 200433
- Site Reference ID/Investigator# 72875
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Shenyang, China, 110001
- Site Reference ID/Investigator# 72883
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Wuhan, Hubei, China, 430022
- Site Reference ID/Investigator# 72977
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Xi'an, China, 710032
- Site Reference ID/Investigator# 72975
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
placebo
|
placebo
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Experimental: Adalimumab
Adalimumab 40 mg every other week (eow)
|
adalimumab eow
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12
Time Frame: Week 12
|
The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked).
The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period A]
Time Frame: Weeks 3 and 7
|
The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI), other than Week 12. PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked).
The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
|
Weeks 3 and 7
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period B]
Time Frame: Weeks 16, 19, and 24
|
The percentage of participants with a greater than or equal to 75% reduction (improvement) in Psoriasis Area and Severity Index (PASI).
PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked).
The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
|
Weeks 16, 19, and 24
|
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period A]
Time Frame: Baseline to Week 12
|
Psoriasis Area and Severity Index (PASI), is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked).
The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
|
Baseline to Week 12
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Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period B]
Time Frame: Baseline to Week 24
|
PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked).
The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
|
Baseline to Week 24
|
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]
Time Frame: Weeks 3, 7, and 12
|
The percentage of participants with a greater than or equal to 50%, 90%, or 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI 50/90/100).
PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked).
The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
|
Weeks 3, 7, and 12
|
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]
Time Frame: Weeks 16, 19, and 24
|
The percentage of participants with a greater than or equal to 50%, 90%, or 100% reduction (improvement) in Psoriasis Area and Severity Index (PASI 50/90/100).
PASI is a composite measure of the level of erythema (redness of the skin), induration (hardening of the skin), and desquamation (peeling of the skin) on 4 sites (head, upper extremities, trunk, and lower extremities), each of which are rated on a 5-point scale from 0 (no symptoms) to 4 (very marked).
The possible range for PASI score is 0 to 72, with the highest score representing complete erythroderma of the severest possible degree; a decrease in score indicates improvement.
|
Weeks 16, 19, and 24
|
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period A]
Time Frame: Baseline and Weeks 3, 7, and 12
|
The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'
|
Baseline and Weeks 3, 7, and 12
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Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period B]
Time Frame: Weeks 16, 19, and 24
|
The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'
|
Weeks 16, 19, and 24
|
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period A]
Time Frame: Baseline and Weeks 3, 7, and 12
|
The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'
|
Baseline and Weeks 3, 7, and 12
|
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period B]
Time Frame: Weeks 16, 19, and 24
|
The Physician's Global Assessment (PGA) is a 6-point scale used to measure the severity of disease at the time of the physician's evaluation of the participant ranging from 'clear' (meaning no signs of plaque) to 'severe.'
|
Weeks 16, 19, and 24
|
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period A]
Time Frame: Baseline, Week 3, and Week 12
|
The DLQI measures how much a subject's skin problem affected their life over the last week.
The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.
|
Baseline, Week 3, and Week 12
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Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period B]
Time Frame: Week 16 and Week 24
|
The DLQI measures how much a participant's skin problem affected their life over the last week.
The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.
|
Week 16 and Week 24
|
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period A]
Time Frame: Baseline, Week 3, and Week 12
|
The DLQI measures how much a subject's skin problem affected their life over the last week.
The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.
|
Baseline, Week 3, and Week 12
|
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period B]
Time Frame: Week 16 and Week 24
|
The DLQI measures how much a participant's skin problem affected their life over the last week.
The possible range for DLQI was 0 to 30, with a higher score indicating a more impaired quality of life; a decrease in score indicates improvement.
|
Week 16 and Week 24
|
Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period A]
Time Frame: Baseline to Week 12
|
Short Form-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS).
The SF-36 consists of 8 subscales.
The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception.
The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health.
Participants self-report on items in a subscale that have choices per item.
Summations of item scores of the same subscale give the subscale scores, which were transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL.
PCS and MCS scores were constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score.
The difference from baseline to week 12 in SF-36 PCS and MCS was calculated.
|
Baseline to Week 12
|
Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period B]
Time Frame: Baseline to Week 24
|
Short Form-36 is a generic 36-item questionnaire measuring health-related quality of life (HRQL) covering 2 summary measures: physical component summary (PCS) and mental component summary (MCS).
The SF-36 consists of 8 subscales.
The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception.
The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health.
Participants self-report on items in a subscale that have choices per item.
Summations of item scores of the same subscale give the subscale scores, which were transformed into a range from 0 to 100; zero= worst HRQL, 100=best HRQL.
PCS and MCS scores were constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score.
The difference from baseline to week 12 in SF-36 PCS and MCS was calculated.
|
Baseline to Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Martin Okun, MD, AbbVie
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
July 18, 2012
First Submitted That Met QC Criteria
July 18, 2012
First Posted (Estimate)
July 20, 2012
Study Record Updates
Last Update Posted (Estimate)
January 19, 2015
Last Update Submitted That Met QC Criteria
January 14, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M13-606
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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