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Special Investigation in Patients With Psoriasis Vulgaris and Psoriatic Arthritis (All Patients Investigation)

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ClinicalTrials.gov Identifier: NCT01155570
Recruitment Status : Completed
First Posted : July 2, 2010
Results First Posted : October 8, 2013
Last Update Posted : October 8, 2013
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Psoriasis
Enrollment 752
Recruitment Details Ninety-four participants entered this study from study NCT00647400 (M04-702), a Phase III extension study of Humira (adalimumab) in Japan.
Pre-assignment Details Of the 752 participants registered, 4 participants did not have case report forms retrieved (2 whose registration was duplicated and 2 who did not receive Humira). Of the remaining 748 participants, 14 were excluded from analysis (7 changed hospital after registration, 7 didn't visit clinic after the first Humira administration).
Arm/Group Title Humira
Hide Arm/Group Description Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Period Title: Overall Study
Started 734 [1]
Efficacy Analysis Population 708 [2]
Completed 592
Not Completed 142
Reason Not Completed
Adverse Event             39
Lack of Efficacy             46
Participant's Economic Reasons             17
No Hospital Visits             7
Adverse Event + Lack of Efficacy             2
Adverse Event + Other Reasons             7
Participant's Economic Reasons + Other             1
Other Reasons             23
[1]
Safety Analysis Population
[2]
5 received Humira off-label, 21 did not receive Humira after the first administration
Arm/Group Title Humira
Hide Arm/Group Description Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Baseline Participants 734
Hide Baseline Analysis Population Description
Safety Analysis Population
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 734 participants
50.7  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 734 participants
Female
176
  24.0%
Male
558
  76.0%
Physician's Global Assessment (PGA)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 734 participants
2.7  (5.7)
[1]
Measure Description: 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. The degree of overall lesion severity was evaluated using the following categories: 0 (Clear); 1 (Minimal); 2 (Mild); 3 (Moderate); 4 (Severe); 5 (Very Severe). PGA was assessed at baseline in 644 participants.
Psoriasis Area and Severity Index (PASI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 734 participants
15.7  (12.2)
[1]
Measure Description: Psoriasis Area and Severity Index (PASI) is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions, and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI was assessed at baseline in 625 participants.
Dermatology Life Quality Index (DLQI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 734 participants
8.43  (6.77)
[1]
Measure Description: Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each question are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. DLQI was assessed at baseline in 280 participants.
Pain Visual Analog Scale (VAS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 734 participants
49.5  (30.7)
[1]
Measure Description: Participants assessed their pain due to psoriatic arthritis in the last week, on a a single-line Visual Analogue Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be). VAS was assessed at baseline in 153 participants.
Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR])   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 734 participants
4.4  (1.7)
[1]
Measure Description: DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0.49 to 9.07. A DAS28-4 score less than 2.6 indicates clinical remission, DAS28-4 2.6 to 3.2 indicates low disease activity, DAS28-4 3.2 to less than 5.1 indicates moderate disease activity, and DAS28-4 of 5.1 or greater indicates high disease activity. DAS28-4 (ESR) was assessed at baseline in 94 participants with psoriatic arthritis.
Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP])   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 734 participants
3.5  (1.3)
[1]
Measure Description: DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0.49 to 9.07. A DAS28-4 score less than 2.6 indicates clinical remission, DAS28-4 2.6 to 3.2 indicates low disease activity, DAS28-4 3.2 to less than 5.1 indicates moderate disease activity, and DAS28-4 of 5.1 or greater indicates high disease activity. DAS28-4 (CRP) was assessed at baseline in 131 participants with psoriatic arthritis.
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), Deaths, and Discontinuations Due to AEs
Hide Description This study was mandated by the Japanese government as an approval condition for Humira in Japan; therefore, definitions of adverse events and seriousness criteria were applicable as specified in the Japanese local standard operating procedures, based on local Japanese regulations. ADRs were defined as adverse events for which the causal relationship with Humira was other than “not related” (ie, “probable,” “possible,” or “unclear”). The count of participants with AEs presented in this table includes serious and nonserious AEs. The count of participants with discontinuations due to AEs includes those who discontinued due to an AE plus other reasons. Please see Safety section for further details regarding adverse events.
Time Frame From study registration through Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Population
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 734
Measure Type: Number
Unit of Measure: participants
AEs 237
SAEs 35
ADRs 191
SADRs 24
Deaths 4
Discontinuations Due to AEs 48
2.Primary Outcome
Title Physician's Global Assessment at Week 4
Hide Description

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. The degree of overall lesion severity was evaluated using the following categories:

  • 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);
  • 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);
  • 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);
  • 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);
  • 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);
  • 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe).
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 640
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.2  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments comparison versus Baseline at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Primary Outcome
Title Physician's Global Assessment At Week 8
Hide Description

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. The degree of overall lesion severity was evaluated using the following categories:

  • 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);
  • 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);
  • 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);
  • 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);
  • 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);
  • 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe).
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 591
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.8  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments comparison versus Baseline at Week 8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Primary Outcome
Title Physician's Global Assessment at Week 16
Hide Description

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. The degree of overall lesion severity was evaluated using the following categories:

  • 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);
  • 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);
  • 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);
  • 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);
  • 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);
  • 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 550
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.5  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments comparison versus Baseline at Week 16
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Primary Outcome
Title Physician's Global Assessment at Week 24
Hide Description

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. The degree of overall lesion severity was evaluated using the following categories:

  • 0 / Clear (plaque elevation=none, scaling=none, erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration);
  • 1 / Minimal (plaque elevation=possible but difficult to ascertain whether there is a slight elevation above normal skin, scaling=surface dryness with some white coloration, erythema=up to moderate);
  • 2 / Mild (plaque elevation=slight, scaling=fine, erythema=up to moderate);
  • 3 / Moderate (plaque elevation=moderate, scaling=coarser, erythema=moderate);
  • 4 / Severe (plaque elevation=marked, scaling=coarse, erythema=severe);
  • 5 / Very Severe (plaque elevation=very marked, scaling=very coarse, erythema=very severe).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 502
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.2  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments comparison versus Baseline at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Primary Outcome
Title Psoriasis Area and Severity Index (PASI) at Week 16
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 522
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.0  (7.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments comparison versus Baseline at Week 16
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Primary Outcome
Title Psoriasis Area and Severity Index (PASI) at Week 24
Hide Description PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 476
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.0  (7.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments comparison versus Baseline at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Primary Outcome
Title Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16
Hide Description PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score.
Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira (All Participants) Humira (Adalimumab-naive Participants)
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Overall Number of Participants Analyzed 522 463
Measure Type: Number
Unit of Measure: percentage of participants
49.2 52.9
9.Primary Outcome
Title Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response at Week 24
Hide Description PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira (All Participants) Humira (Adalimumab-naive Participants)
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Overall Number of Participants Analyzed 476 422
Measure Type: Number
Unit of Measure: percentage of participants
58.2 62.1
10.Primary Outcome
Title Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 16
Hide Description PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score.
Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira (All Participants) Humira (Adalimumab-naive Participants)
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Overall Number of Participants Analyzed 522 463
Measure Type: Number
Unit of Measure: percentage of participants
27.0 28.7
11.Primary Outcome
Title Percentage of Participants With Psoriasis Area and Severity Index 90 (PASI90) Response at Week 24
Hide Description PASI90 is defined as at least a 90% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0 (best) to 72 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 24 PASI score) divided by Week 0 PASI score.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira (All Participants) Humira (Adalimumab-naive Participants)
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
Overall Number of Participants Analyzed 476 422
Measure Type: Number
Unit of Measure: percentage of participants
39.3 41.7
12.Primary Outcome
Title Dermatology Life Quality Index at Week 16
Hide Description Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 205
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.01  (4.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments comparison versus Baseline at Week 16
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
13.Primary Outcome
Title Dermatology Life Quality Index at Week 24
Hide Description Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 193
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.30  (3.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments comparison versus Baseline at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
14.Primary Outcome
Title Pain Visual Analog Scale (VAS) at Week 4
Hide Description Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 133
Mean (Standard Deviation)
Unit of Measure: units on a scale
26.7  (26.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments comparison versus Baseline at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
15.Primary Outcome
Title Pain Visual Analog Scale (VAS) at Week 16
Hide Description Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: units on a scale
21.3  (23.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments comparison versus Baseline at Week 16
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
16.Primary Outcome
Title Pain Visual Analog Scale (VAS) at Week 24
Hide Description Participants assessed their pain due to psoriatic arthritis in the past week, on a single-line Visual Analog Scale (VAS) from 0 (no pain) to 100 (pain as bad as it could be).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 116
Mean (Standard Deviation)
Unit of Measure: units on a scale
16.3  (21.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments comparison versus Baseline at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
17.Primary Outcome
Title Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 4
Hide Description DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 69
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.0  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments comparison versus Baseline at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
18.Primary Outcome
Title Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 16
Hide Description DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 61
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.4  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments comparison versus Baseline at Week 16
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
19.Primary Outcome
Title Disease Activity Score 28-4, Erythrocyte Sedimentation Rate (DAS28-4 [ESR]) at Week 24
Hide Description DAS28-4 (ESR) is calculated using the number of tender and swollen joints (out of 28 counted), erythrocyte sedimentation rate (ESR), and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.3  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments comparison versus Baseline at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
20.Primary Outcome
Title Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 4
Hide Description DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 97
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.3  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments comparison versus Baseline at Week 4
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
21.Primary Outcome
Title Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 16
Hide Description DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 82
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.0  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments comparison versus Baseline at Week 16
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
22.Primary Outcome
Title Disease Activity Score 28-4, C-reactive Protein (DAS28-4 [CRP]) at Week 24
Hide Description DAS28-4 (CRP) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein (CRP) level, and the patient's global assessment of disease activity via the visual analog scale (VAS). The calculated range of DAS28-4 is 0 to 10. A score less than 2.6 indicates clinical remission, a score of 2.6 to 3.2 indicates low disease activity, a score of 3.2 to less than 5.1 indicates moderate disease activity, and a score of 5.1 or greater indicates high disease activity.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Observed cases: participants with psoriatic arthritis in the Efficacy Analysis Population with an assessment at time point.
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 85
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.8  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Humira
Comments comparison versus Baseline at Week 24
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
23.Secondary Outcome
Title Physician’s Overall Response Rating At Week 24
Hide Description Overall response rating, according to investigator’s subjective clinical opinion. The level of overall improvement rating was categorized as “markedly improved,” “improved,” “not changed,” or "not assessable," comparing clinical conditions at Week 24 or at discontinuation with Baseline conditions.
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Efficacy Analysis Population with assessment at Week 24.
Arm/Group Title Humira
Hide Arm/Group Description:
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
Overall Number of Participants Analyzed 700
Measure Type: Number
Unit of Measure: participants
Markedly improved 354
Improved 255
Not changed 65
Aggravated 16
Not assessable 10
Time Frame From study registration through Week 24
Adverse Event Reporting Description Safety Analysis Population
 
Arm/Group Title Humira
Hide Arm/Group Description Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
All-Cause Mortality
Humira
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Humira
Affected / at Risk (%)
Total   35/734 (4.77%) 
Cardiac disorders   
Angina pectoris * 1  1/734 (0.14%) 
Myocardial infarction * 1  1/734 (0.14%) 
Gastrointestinal disorders   
Bleeding gastric ulcer * 1  1/734 (0.14%) 
Pancreatic cyst * 1  1/734 (0.14%) 
Alcoholic pancreatitis * 1  1/734 (0.14%) 
General disorders   
Chest pain * 1  1/734 (0.14%) 
Malaise * 1  1/734 (0.14%) 
Edema * 1  1/734 (0.14%) 
Pyrexia * 1  2/734 (0.27%) 
Hepatobiliary disorders   
Alcoholic liver disease * 1  1/734 (0.14%) 
Cholecystitis * 1  1/734 (0.14%) 
Cholelithiasis * 1  2/734 (0.27%) 
Infections and infestations   
Diverticulitis * 1  1/734 (0.14%) 
Encephalitis herpes * 1  1/734 (0.14%) 
External ear cellulitis * 1  1/734 (0.14%) 
Herpes zoster * 1  2/734 (0.27%) 
Meningitis bacterial * 1  1/734 (0.14%) 
Pneumonia pneumococcal * 1  1/734 (0.14%) 
Pulmonary tuberculosis * 1  1/734 (0.14%) 
Injury, poisoning and procedural complications   
Splenic rupture * 1  1/734 (0.14%) 
Brain contusion * 1  1/734 (0.14%) 
Investigations   
C-reactive protein increased * 1  1/734 (0.14%) 
Liver function test abnormal * 1  1/734 (0.14%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  1/734 (0.14%) 
Musculoskeletal and connective tissue disorders   
Rotator cuff syndrome * 1  1/734 (0.14%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer * 1  1/734 (0.14%) 
Gallbladder cancer * 1  1/734 (0.14%) 
Esophageal carcinoma * 1  1/734 (0.14%) 
Gastric neoplasm * 1  1/734 (0.14%) 
Nervous system disorders   
Cerebral hemorrhage * 1  1/734 (0.14%) 
Cerebral infarction * 1  1/734 (0.14%) 
Renal and urinary disorders   
Tubulointerstitial nephritis * 1  1/734 (0.14%) 
Renal impairment * 1  1/734 (0.14%) 
Respiratory, thoracic and mediastinal disorders   
Interstitial lung disease * 1  1/734 (0.14%) 
Skin and subcutaneous tissue disorders   
Psoriasis * 1  1/734 (0.14%) 
Pustular psoriasis * 1  3/734 (0.41%) 
Dermatitis psoriasiform * 1  1/734 (0.14%) 
Vascular disorders   
Temporal arteritis * 1  1/734 (0.14%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Humira
Affected / at Risk (%)
Total   0/734 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
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Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01155570     History of Changes
Other Study ID Numbers: P12-077
First Submitted: June 30, 2010
First Posted: July 2, 2010
Results First Submitted: July 23, 2013
Results First Posted: October 8, 2013
Last Update Posted: October 8, 2013