Safety and Efficacy Study of Adalimumab in the Treatment of Plaque Psoriasis

Phase 3

Completed

Conditions: Plaque Psoriasis

Interventions: Biological: Adalimumab
Biological: placebo

Registration Number: NCT01646073

Lead Sponsor: AbbVie (prior sponsor, Abbott)

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 425

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adalimumab	Adalimumab	Adalimumab 40 mg every other week (eow)
Placebo	placebo	placebo

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at Week 12	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period A]	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.
Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period B]	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.
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period A]	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.
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period B]	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.
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]	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.
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]	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.
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period A]	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.'
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period B]	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.'
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period A]	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.'
Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period B]	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.'
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period A]	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.
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period B]	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.
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period A]	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.
Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period B]	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.
Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period A]	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.
Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period B]	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.

Trial Locations

Locations (16): Site Reference ID/Investigator# 72976
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Chongqing, China
Site Reference ID/Investigator# 72880
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Dalian, China
Site Reference ID/Investigator# 72974
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Guangzhou, China
Site Reference ID/Investigator# 72888
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Beijing, China
Site Reference ID/Investigator# 72873
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Beijing, China
Site Reference ID/Investigator# 87058
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Jinan, China
Site Reference ID/Investigator# 72878
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Hangzhou, Zhejiang, China
Site Reference ID/Investigator# 72883
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Shenyang, China
Site Reference ID/Investigator# 72973
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Guangzhou, China
Site Reference ID/Investigator# 72977
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Wuhan, Hubei, China
Site Reference ID/Investigator# 85693
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Chengdu, China
Site Reference ID/Investigator# 72877
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Hangzhou, Zhejiang, China
Site Reference ID/Investigator# 72876
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Shanghai, China
Site Reference ID/Investigator# 72875
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Shanghai, China
Site Reference ID/Investigator# 72887
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Beijing, China
Site Reference ID/Investigator# 72975
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Xi'an, China