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A study to evaluate the safety and efficacy of adalimumab in Chinese subjects with moderate to severe plaque psoriasis.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Experimental | Adalimumab 40 mg every other week (eow) |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Biological | adalimumab eow |
|
|
| 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 | 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 |
| 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] | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Okun, MD | AbbVie | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 72888 | Beijing | 100034 | China | |||
| Site Reference ID/Investigator# 72873 |
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| Label | URL |
|---|---|
| Related Info | View source |
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Participants were randomized at Week 0 (Day 1) in a 4:1 ratio to receive either adalimumab every other week (eow) or matching placebo.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants were started on placebo in Period A and then switched to adalimumab 40 mg eow in Period B |
| FG001 | Adalimumab Eow | Participants were started on 40 mg adalimumab every other week (eow) in Period A and continued adalimumab 40 mg eow into Period B |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period A (12 Weeks) |
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| |||||||||||||||||||||
| Period B (12 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B |
| BG001 | Adalimumab Eow | Participants were started on adalimumab 40 mg every other week (eow) in Period A and continued adalimumab 40 mg eow into Period B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response at 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. | Intent to Treat Population A (ITT_A): all participants who were randomized at Week 0 (Baseline); Non-responder imputation (NRI): any participant who had a missing value at a specific visit as non-responder for that visit. | Posted | Number | percentage of participants | Week 12 |
|
Baseline up to 70 days after last dose (week 24).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Double-blind Placebo | Participants were started on placebo in Period A (Week 0 to Week 12) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ARRHYTHMIA | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| placebo | Biological | placebo |
|
| 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] | 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] | 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 |
| Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period B] | 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] | 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] | 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] | 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" [Period B] | 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] | 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] | 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] | 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" [Period B] | 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] | 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] | 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] | 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] | 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 |
| Beijing |
| 100044 |
| China |
| Site Reference ID/Investigator# 72887 | Beijing | 100730 | China |
| Site Reference ID/Investigator# 85693 | Chengdu | 610072 | China |
| Site Reference ID/Investigator# 72976 | Chongqing | 400038 | China |
| Site Reference ID/Investigator# 72880 | Dalian | 116011 | China |
| Site Reference ID/Investigator# 72973 | Guangzhou | 510120 | China |
| Site Reference ID/Investigator# 72974 | Guangzhou | 510630 | China |
| Site Reference ID/Investigator# 72878 | Hangzhou, Zhejiang | 310003 | China |
| Site Reference ID/Investigator# 72877 | Hangzhou, Zhejiang | 310009 | China |
| Site Reference ID/Investigator# 87058 | Jinan | 250012 | China |
| Site Reference ID/Investigator# 72876 | Shanghai | 200025 | China |
| Site Reference ID/Investigator# 72875 | Shanghai | 200433 | China |
| Site Reference ID/Investigator# 72883 | Shenyang | 110001 | China |
| Site Reference ID/Investigator# 72977 | Wuhan, Hubei | 430022 | China |
| Site Reference ID/Investigator# 72975 | Xi'an | 710032 | China |
| Lack of Efficacy |
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| Protocol Violation |
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| Other |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Duration of Psoriasis | Mean | Standard Deviation | years |
|
| Body Surface Area with Psoriasis | Mean | Standard Deviation | Percentage of Body Surface Area |
|
| Psoriasis Area and Severity Index | 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. | Mean | Standard Deviation | units on a scale |
|
| Physician's Global Assessment of Psoriasis | Number | participants |
|
| OG000 |
| Placebo |
Participants were started on placebo in Period A (Week 0 to Week 12). |
| OG001 | Adalimumab Eow | Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12). |
|
|
| Secondary | Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period A] | 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. | ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit. | Posted | Number | percentage of participants | Weeks 3 and 7 |
|
|
|
| Secondary | Percentage of Participants Achieving a Psoriasis Area and Severity Index Greater Than or Equal to 75% Reduction (PASI 75) Response [Period B] | 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. | Intent to Treat Population B (ITT_B): all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit. | Posted | Number | percentage of participants | Weeks 16, 19, and 24 |
|
|
|
| Secondary | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period A] | 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. | ITT_A: all participants that were randomized in Week 0 (Baseline); Last observation carried forward (LOCF): used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward. | Posted | Mean | Standard Error | Percent change | Baseline to Week 12 |
|
|
|
| Secondary | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score [Period B] | 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. | ITT_B: all participants who received at least 1 dose of study drug in Period B; LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward. | Posted | Mean | Standard Deviation | percent change | Baseline to Week 24 |
|
|
|
| Secondary | 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] | 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. | ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit. | Posted | Number | percentage of participants | Weeks 3, 7, and 12 |
|
|
|
| Secondary | 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] | 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. | ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit. | Posted | Number | percentage of participants | Weeks 16, 19, and 24 |
|
|
|
| Secondary | Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period A] | 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.' | ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit. | Posted | Number | percentage of participants | Baseline and Weeks 3, 7, and 12 |
|
|
|
| Secondary | Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" [Period B] | 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.' | ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit. | Posted | Number | percentage of participants | Weeks 16, 19, and 24 |
|
|
|
| Secondary | Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period A] | 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.' | ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit. | Posted | Number | percentage of participants | Baseline and Weeks 3, 7, and 12 |
|
|
|
| Secondary | Percentage of Participants With a Physician's Global Assessment (PGA) of "Clear" or "Minimal" [Period B] | 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.' | ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit. | Posted | Number | percentage of participants | Weeks 16, 19, and 24 |
|
|
|
| Secondary | Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period A] | 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. | ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit. | Posted | Number | percentage of participants | Baseline, Week 3, and Week 12 |
|
|
|
| Secondary | Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0" [Period B] | 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. | ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit. | Posted | Number | percentage of participants | Week 16 and Week 24 |
|
|
|
| Secondary | Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period A] | 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. | ITT_A: all participants that were randomized in Week 0 (Baseline); NRI: any participant who had a missing value at a specific visit as non-responder for that visit. | Posted | Number | percentage of participants | Baseline, Week 3, and Week 12 |
|
|
|
| Secondary | Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Score of "0 or 1" [Period B] | 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. | ITT_B: all participants who received at least 1 dose of study drug in Period B; NRI: any participant who had a missing value at a specific visit as non-responder for that visit. | Posted | Number | percentage of participants | Week 16 and Week 24 |
|
|
|
| Secondary | Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period A] | 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. | ITT_A: all participants that were randomized in Week 0 (Baseline); LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward. | Posted | Mean | Standard Error | scores on a scale | Baseline to Week 12 |
|
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| Secondary | Change From Baseline in the Short Form 36 (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) [Period B] | 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. | ITT_B: all participants who received at least 1 dose of study drug in Period B; LOCF: used the completed evaluation from the previous visit within the particular period for efficacy measures assessed to impute missing data at later visits in the same period. Baseline efficacy evaluations were not carried forward. | Posted | Mean | Standard Deviation | scores on a scale | Baseline to Week 24 |
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|
|
| 3 |
| 87 |
| 14 |
| 87 |
| EG001 | Double-blind Adalimumab Eow | Participants were started on adalimumab eow in Period A (Week 0 to Week 12) | 4 | 338 | 64 | 338 |
| EG002 | Any Adalimumab | Participants that received at least one dose of adalimumab during Period A or Period B | 15 | 423 | 137 | 423 |
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| MYOCARDITIS | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
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| PYLORIC STENOSIS | Congenital, familial and genetic disorders | MedDRA 16.1 | Systematic Assessment |
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| RETINAL DETACHMENT | Eye disorders | MedDRA 16.1 | Systematic Assessment |
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| GASTRIC ULCER | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| LUNG INFECTION | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| LYMPH NODE TUBERCULOSIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| TUBERCULOSIS | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| LUMBAR VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| SKIN INJURY | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| PSORIATIC ARTHROPATHY | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| ENDOMETRIAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
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| GASTRIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
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| CEREBRAL INFARCTION | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
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| HAEMATURIA | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
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| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| PLEURAL FIBROSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| ERYTHEMA MULTIFORME | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Week 24 |
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| PASI 100 [Week 3] |
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| PASI 50 [Week 7] |
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| PASI 90 [Week 7] |
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| PASI 100 [Week 7] |
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| PASI 50 [Week 12] |
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| PASI 90 [Week 12] |
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| PASI 100 [Week 12] |
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| PASI 100 [Week 16] |
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| PASI 50 [Week 19] |
|
| PASI 90 [Week 19] |
|
| PASI 100 [Week 19] |
|
| PASI 50 [Week 24] |
|
| PASI 90 [Week 24] |
|
| PASI 100 [Week 24] |
|
| Week 7 |
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| Week 12 |
|
| Week 24 |
|
| Week 7 |
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| Week 12 |
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| Week 24 |
|
| Week 12 |
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| Week 12 |
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