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

• ClinicalTrials.gov Identifier: NCT01646073
• Recruitment Status: Completed
• First Posted: July 20, 2012
• Results First Posted: January 19, 2015
• Last Update Posted: January 19, 2015
• Sponsor: AbbVie (prior sponsor, Abbott)
• Information provided by (Responsible Party): AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Plaque Psoriasis	Biological: Adalimumab; Biological: placebo	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 425 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: August 2012
• Actual Primary Completion Date: December 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Adalimumab; Adalimumab 40 mg every other week (eow)	Biological: Adalimumab; adalimumab eow; Other Names: ABT-D2E7; Humira
Placebo Comparator: Placebo; placebo	Biological: placebo; placebo

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.'
8. 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.'
9. 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.'
10. 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.'
11. 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.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

China

Site Reference ID/Investigator# 72888

Beijing, China, 100034

Site Reference ID/Investigator# 72873

Beijing, China, 100044

Site Reference ID/Investigator# 72887

Beijing, China, 100730

Site Reference ID/Investigator# 85693

Chengdu, China, 610072

Site Reference ID/Investigator# 72976

Chongqing, China, 400038

Site Reference ID/Investigator# 72880

Dalian, China, 116011

Site Reference ID/Investigator# 72973

Guangzhou, China, 510120

Site Reference ID/Investigator# 72974

Guangzhou, China, 510630

Site Reference ID/Investigator# 72878

Hangzhou, Zhejiang, China, 310003

Site Reference ID/Investigator# 72877

Hangzhou, Zhejiang, China, 310009

Site Reference ID/Investigator# 87058

Jinan, China, 250012

Site Reference ID/Investigator# 72876

Shanghai, China, 200025

Site Reference ID/Investigator# 72875

Shanghai, China, 200433

Site Reference ID/Investigator# 72883

Shenyang, China, 110001

Site Reference ID/Investigator# 72977

Wuhan, Hubei, China, 430022

Site Reference ID/Investigator# 72975

Xi'an, China, 710032

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

• Study Chair: Martin Okun, MD; AbbVie

More Information

Additional Information:

Related Info 

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01646073
• Other Study ID Numbers: M13-606
• First Posted: July 20, 2012
• Results First Posted: January 19, 2015
• Last Update Posted: January 19, 2015
• Last Verified: January 2015

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Plaque Psoriasis; Psoriasis; Placebo Controlled; Skin Disease; Double Blind

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Adalimumab; Anti-Inflammatory Agents; Antirheumatic Agents