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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01646073
First received: July 18, 2012
Last updated: January 14, 2015
Last verified: January 2015
  Purpose

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


Condition Intervention Phase
Plaque Psoriasis
Biological: Adalimumab
Biological: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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] [ Time Frame: Weeks 16, 19, and 24 ] [ Designated as safety issue: No ]
    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] [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    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] [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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] [ Time Frame: Weeks 3, 7, and 12 ] [ Designated as safety issue: No ]
    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] [ Time Frame: Weeks 16, 19, and 24 ] [ Designated as safety issue: No ]
    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] [ Time Frame: Baseline and Weeks 3, 7, and 12 ] [ Designated as safety issue: No ]
    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] [ Time Frame: Weeks 16, 19, and 24 ] [ Designated as safety issue: No ]
    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] [ Time Frame: Baseline and Weeks 3, 7, and 12 ] [ Designated as safety issue: No ]
    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] [ Time Frame: Weeks 16, 19, and 24 ] [ Designated as safety issue: No ]
    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] [ Time Frame: Baseline, Week 3, and Week 12 ] [ Designated as safety issue: No ]
    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] [ Time Frame: Week 16 and Week 24 ] [ Designated as safety issue: No ]
    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] [ Time Frame: Baseline, Week 3, and Week 12 ] [ Designated as safety issue: No ]
    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] [ Time Frame: Week 16 and Week 24 ] [ Designated as safety issue: No ]
    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] [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    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] [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
    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.


Enrollment: 425
Study Start Date: August 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01646073

Locations
China
Site Reference ID/Investigator# 72873
Beijing, China, 100044
Site Reference ID/Investigator# 72887
Beijing, China, 100730
Site Reference ID/Investigator# 72888
Beijing, China, 100034
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# 72875
Shanghai, China, 200433
Site Reference ID/Investigator# 72876
Shanghai, China, 200025
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:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01646073     History of Changes
Other Study ID Numbers: M13-606
Study First Received: July 18, 2012
Results First Received: December 19, 2014
Last Updated: January 14, 2015
Health Authority: China: Food and Drug Administration

Keywords provided by AbbVie:
Plaque Psoriasis
Psoriasis
Placebo Controlled
Skin Disease
Double Blind

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 29, 2015