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Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities (EPIC)

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ClinicalTrials.gov Identifier: NCT01401452
Recruitment Status : Completed
First Posted : July 25, 2011
Results First Posted : October 4, 2017
Last Update Posted : October 4, 2017
Sponsor:
Collaborator:
Raffeiner GmbH
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Moderate to Severe Plaque Psoriasis
Enrollment 246
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Participants With Psoriasis and at Least One Co-morbid Disease
Hide Arm/Group Description Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
Period Title: Overall Study
Started 246
Visit 1 (Baseline) 246
Visit 2 (1 Month) 225
Visit 3 (3 Months) 217
Visit 4 (6 Months) 172
Visit 5 (9 Months) 175
Completed 174
Not Completed 72
Reason Not Completed
Adverse reaction             9
Lost to Follow-up             12
Lack of Efficacy             30
Participant developed breast cancer             1
Tx stopped due to financial reasons             1
Tx stopped by psychiatrist             1
No more visits within the 36 wk followup             4
Subject did not come to follow up visits             2
Subject didn't return for routine visits             1
Subject moved to another city             1
Subject's wife wants to get pregnant             1
Psoriatic arthritis             1
Participant stopped Tx             2
Discontinuation for personal reasons             1
Treatment failure             1
Unsatisfactory output             1
Subject withdrew because of Tx success             1
Subject chose to discontinue treatment             1
Participant withdrew consent             1
Arm/Group Title Participants With Psoriasis and at Least One Co-morbid Disease
Hide Arm/Group Description Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
Overall Number of Baseline Participants 246
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 246 participants
48.8  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 246 participants
Female
93
  37.8%
Male
153
  62.2%
Duration of psoriasis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 246 participants
18.6  (13.6)
Number of participants with comorbidities   [1] 
Measure Type: Number
Unit of measure:  Participants
Female Number Analyzed 93 participants
93
Male Number Analyzed 153 participants
152
[1]
Measure Analysis Population Description: Males and females were analyzed separately
Most prevalent co-morbidities among participants in the study  
Measure Type: Number
Unit of measure:  Participants
Psoriatic arthritis Number Analyzed 246 participants
114
Hypertension Number Analyzed 246 participants
79
Metabolic syndrome Number Analyzed 246 participants
72
Obesity Number Analyzed 246 participants
64
Diabetes Number Analyzed 246 participants
31
1.Primary Outcome
Title Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Months 1, 3, 6, and 9
Hide Description The percentage of participants with a ≥ 75% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Time Frame Baseline, Months 1, 3, 6, and 9
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title Participants With Psoriasis and at Least One Co-morbid Disease
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
Overall Number of Participants Analyzed 208
Measure Type: Number
Unit of Measure: percentage of participants
1 month Number Analyzed 208 participants
31.3
3 months Number Analyzed 193 participants
52.8
6 months Number Analyzed 154 participants
55.8
9 months Number Analyzed 167 participants
57.5
2.Secondary Outcome
Title Mean Dermatology Life Quality Index (DLQI) Scores
Hide Description The DLQI questionnaire asks participants to evaluate the degree that psoriasis has affected their quality of life in the last week, and includes the following parameters: symptoms and feelings, daily activities, leisure activities, work or school activities, personal relationships and treatment- related feelings. Participants respond to 10 questions on a scale from 0 (not at all) to 3 (very much); the range of the total score is 0 to 30. A score of 21 to 30 means that psoriasis has an extremely large effect on the participant's life whereas 0-1 means that the disease has no effect at all.
Time Frame Baseline, Months 1, 3, 6, and 9
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title Participants With Psoriasis and at Least One Co-morbid Disease
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
Overall Number of Participants Analyzed 238
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 238 participants
12.4  (8.0)
1 month Number Analyzed 214 participants
7.2  (7.1)
3 months Number Analyzed 199 participants
5.4  (6.6)
6 months Number Analyzed 158 participants
4.8  (6.0)
9 months Number Analyzed 169 participants
4.3  (5.7)
3.Secondary Outcome
Title Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI 50) Response at Months 1, 3, 6, and 9
Hide Description The percentage of participants with a ≥ 50% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Time Frame Baseline, Months 1, 3, 6, and 9
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title Participants With Psoriasis and at Least One Co-morbid Disease
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
Overall Number of Participants Analyzed 208
Measure Type: Number
Unit of Measure: percentage of participants
1 month Number Analyzed 208 participants
51.0
3 months Number Analyzed 193 participants
66.8
6 months Number Analyzed 154 participants
66.9
9 months Number Analyzed 167 participants
72.5
4.Secondary Outcome
Title Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI 90) Response at Months 1, 3, 6, and 9
Hide Description The percentage of participants with a ≥ 90% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Time Frame Baseline, Months 1, 3, 6, and 9
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title Participants With Psoriasis and at Least One Co-morbid Disease
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
Overall Number of Participants Analyzed 208
Measure Type: Number
Unit of Measure: percentage of participants
1 month Number Analyzed 208 participants
11.5
3 months Number Analyzed 193 participants
38.9
6 months Number Analyzed 154 participants
45.5
9 months Number Analyzed 167 participants
43.7
5.Secondary Outcome
Title Percentage of Participants Achieving a Psoriasis Area and Severity Index 100 (PASI 100) Response at Months 1, 3, 6, and 9
Hide Description The percentage of participants with a ≥ 100% reduction (improvement) in the Psoriasis Area and Severity Index (PASI) score from baseline was calculated. PASI is a combination of the intensity of psoriasis, assessed by the erythema (reddening), induration (plaque thickness) and desquamation (scaling) on a scale from no symptoms (0), slight (1), moderate (2), marked (3) or very marked (4), together with the percentage of the area affected, rated on a scale from 0 to 6. PASI scoring is performed at four body areas, the head, arms, trunk, and legs. The total PASI score ranges from 0 to 72. The higher the total score, the more severe the disease.
Time Frame Baseline, Months 1, 3, 6, and 9
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title Participants With Psoriasis and at Least One Co-morbid Disease
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
Overall Number of Participants Analyzed 208
Measure Type: Number
Unit of Measure: percentage of participants
1 month Number Analyzed 208 participants
6.3
3 months Number Analyzed 193 participants
22.3
6 months Number Analyzed 154 participants
32.5
9 months Number Analyzed 168 participants
30.4
6.Secondary Outcome
Title Mean Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months
Hide Description The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months.
Time Frame Baseline, Months 1, 3, 6, and 9
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data. Missing values were imputed if single answers were missing for one dimension.
Arm/Group Title Participants With Psoriasis and at Least One Co-morbid Disease
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
Overall Number of Participants Analyzed 232
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 232 participants
46.33  (8.97)
1 month Number Analyzed 207 participants
48.19  (8.87)
3 months Number Analyzed 195 participants
49.54  (8.80)
6 months Number Analyzed 159 participants
49.31  (8.82)
9 months Number Analyzed 162 participants
50.48  (8.24)
7.Secondary Outcome
Title Mean Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months
Hide Description The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months.
Time Frame Baseline, Months 1, 3, 6, and 9
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data. Missing values were imputed if single answers were missing for one dimension.
Arm/Group Title Participants With Psoriasis and at Least One Co-morbid Disease
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
Overall Number of Participants Analyzed 234
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 234 participants
41.35  (11.32)
1 month Number Analyzed 208 participants
45.39  (10.43)
3 months Number Analyzed 195 participants
47.01  (10.25)
6 months Number Analyzed 159 participants
47.92  (10.26)
9 months Number Analyzed 162 participants
48.32  (9.89)
8.Secondary Outcome
Title Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months
Hide Description The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months. The percentage of participants achieving MCID in the SF-36 PCS was defined as an increase in PCS of at least 3 points from the baseline score.
Time Frame Baseline, Months 1, 3, 6, and 9
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title Participants With Psoriasis and at Least One Co-morbid Disease
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
Overall Number of Participants Analyzed 201
Measure Type: Number
Unit of Measure: percentage of participants
1 month Number Analyzed 201 participants
38.3
3 months Number Analyzed 187 participants
52.9
6 months Number Analyzed 150 participants
48.0
9 months Number Analyzed 154 participants
55.2
9.Secondary Outcome
Title Percentage of Participants Achieving Minimal Clinically Important Difference (MCID) in Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months
Hide Description The Health Assessment Questionnaire Short Form 36 (SF-36) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). Increases from baseline indicate improvement. Assessments were conducted at baseline, 1 month, 6 months, and 9 months. The percentage of participants achieving MCID in the SF-36 MCS was defined as an increase in MCS of at least 5 points from the baseline score.
Time Frame Baseline, Months 1, 3, 6, and 9
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data
Arm/Group Title Participants With Psoriasis and at Least One Co-morbid Disease
Hide Arm/Group Description:
Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
Overall Number of Participants Analyzed 204
Measure Type: Number
Unit of Measure: percentage of participants
1 month Number Analyzed 204 participants
38.2
3 months Number Analyzed 189 participants
49.7
6 months Number Analyzed 152 participants
52.6
9 months Number Analyzed 155 participants
61.9
Time Frame Serious adverse events (SAEs) were collected from the time that the informed consent was signed until 70 days after the last dose of study drug (up to 46 weeks). Nonserious adverse events were not collected for this study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Participants With Psoriasis and at Least One Co-morbid Disease
Hide Arm/Group Description Participants with moderate to severe plaque psoriasis with at least one co-morbid disease and/or symptom such as hypertension, psoriatic arthritis confirmed by a rheumatologist or other appropriate specialist, obesity, diabetes, metabolic syndrome or depression
All-Cause Mortality
Participants With Psoriasis and at Least One Co-morbid Disease
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Participants With Psoriasis and at Least One Co-morbid Disease
Affected / at Risk (%)
Total   13/246 (5.28%) 
Blood and lymphatic system disorders   
Lymphocytosis  1  1/246 (0.41%) 
Cardiac disorders   
Acute myocardial infarction  1  2/246 (0.81%) 
Atrial fibrillation  1  1/246 (0.41%) 
General disorders   
Puncture site erythema  1  1/246 (0.41%) 
Infections and infestations   
Pneumonia mycoplasmal  1  1/246 (0.41%) 
Vestibular neuronitis  1  1/246 (0.41%) 
Injury, poisoning and procedural complications   
Upper limb fracture  1  1/246 (0.41%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer  1  1/246 (0.41%) 
Reproductive system and breast disorders   
Priapism  1  1/246 (0.41%) 
Skin and subcutaneous tissue disorders   
Psoriasis  1  1/246 (0.41%) 
Alopecia  1  1/246 (0.41%) 
Basal cell carcinoma  1  1/246 (0.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 19.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants With Psoriasis and at Least One Co-morbid Disease
Affected / at Risk (%)
Total   0/0 
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
Layout table for additonal information
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01401452     History of Changes
Other Study ID Numbers: P12-770
First Submitted: July 1, 2011
First Posted: July 25, 2011
Results First Submitted: May 12, 2017
Results First Posted: October 4, 2017
Last Update Posted: October 4, 2017