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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01401452
First Posted: July 25, 2011
Last Update Posted: October 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Raffeiner GmbH
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
July 1, 2011
July 25, 2011
May 12, 2017
October 4, 2017
October 4, 2017
August 2011
May 2016   (Final data collection date for primary outcome measure)
Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Months 1, 3, 6, and 9 [ Time Frame: Baseline, Months 1, 3, 6, and 9 ]
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.
  • To evaluate the effectiveness of Adalimumab over a period of 9 month by analyzing the Psoriasis Area & Severity Index (PASI) in moderate to severe Plaque Psoriasis patients with distinct co-morbidities [ Time Frame: 9 month ]
  • Psoriasis Area & Severity Index (PASI) (=Inclusion visit) [ Time Frame: 12 month ]
    Observation and assessment for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination.
  • Psoriasis Area & Severity Index (PASI) [ Time Frame: month 1 ]
    Observation and assessment for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination.
  • Psoriasis Area & Severity Index (PASI) [ Time Frame: month 3 ]
    Observation and assessment for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination.
  • Psoriasis Area & Severity Index (PASI) [ Time Frame: month 6 ]
    Observation and assessment for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination.
  • Psoriasis Area & Severity Index (PASI) [ Time Frame: month 9 ]
    Observation and assessment for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination.
Complete list of historical versions of study NCT01401452 on ClinicalTrials.gov Archive Site
  • Mean Dermatology Life Quality Index (DLQI) Scores [ Time Frame: Baseline, Months 1, 3, 6, and 9 ]
    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.
  • Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI 50) Response at Months 1, 3, 6, and 9 [ Time Frame: Baseline, Months 1, 3, 6, and 9 ]
    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.
  • Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI 90) Response at Months 1, 3, 6, and 9 [ Time Frame: Baseline, Months 1, 3, 6, and 9 ]
    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.
  • Percentage of Participants Achieving a Psoriasis Area and Severity Index 100 (PASI 100) Response at Months 1, 3, 6, and 9 [ Time Frame: Baseline, Months 1, 3, 6, and 9 ]
    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.
  • Mean Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months [ Time Frame: Baseline, Months 1, 3, 6, and 9 ]
    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.
  • Mean Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months [ Time Frame: Baseline, Months 1, 3, 6, and 9 ]
    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.
  • 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 [ Time Frame: Baseline, Months 1, 3, 6, and 9 ]
    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.
  • 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 [ Time Frame: Baseline, Months 1, 3, 6, and 9 ]
    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.
  • Dermatology Life Quality Index (DLQI) (=Inclusion visit) [ Time Frame: 12 month ]
    Subjects will complete a DLQI questionnaire at study visits.
  • Dermatology Life Quality Index (DLQI) Subjects will complete a DLQI questionnaire at study visits. [ Time Frame: month 1 ]
    Subjects will complete a DLQI questionnaire at study visits.
  • Dermatology Life Quality Index (DLQI) Subjects will complete a DLQI questionnaire at study visits. [ Time Frame: month 3 ]
    Subjects will complete a DLQI questionnaire at study visits.
  • Dermatology Life Quality Index (DLQI) Subjects will complete a DLQI questionnaire at study visits. [ Time Frame: month 6 ]
    Subjects will complete a DLQI questionnaire at study visits.
  • Dermatology Life Quality Index (DLQI) Subjects will complete a DLQI questionnaire at study visits. [ Time Frame: month 9 ]
    Subjects will complete a DLQI questionnaire at study visits.
  • Evaluation of the prevalence of co-morbidities in consideration of gender (=Inclusion visit) [ Time Frame: 12 month ]
  • Life Quality (=Inclusion visit) [ Time Frame: 12 month ]
    Evaluation of parameters of Life Quality (SF-36) and the Life-Quality for specific co-morbidities (optional)
  • Life Quality [ Time Frame: month 1 ]
    Evaluation of parameters of Life Quality (SF-36) and the Life-Quality for specific co-morbidities (optional)
  • Life Quality [ Time Frame: month 3 ]
    Evaluation of parameters of Life Quality (SF-36) and the Life-Quality for specific co-morbidities (optional)
  • Life Quality [ Time Frame: month 6 ]
    Evaluation of parameters of Life Quality (SF-36) and the Life-Quality for specific co-morbidities (optional)
  • Life Quality [ Time Frame: month 9 ]
    Evaluation of parameters of Life Quality (SF-36) and the Life-Quality for specific co-morbidities (optional)
  • Evaluation of the minimum of clinical important differences (MCID) (=Inclusion visit) [ Time Frame: 12 month ]
  • Evaluation of the minimum of clinical important differences (MCID) [ Time Frame: month 1 ]
  • Evaluation of the minimum of clinical important differences (MCID) [ Time Frame: month 3 ]
  • Evaluation of the minimum of clinical important differences (MCID) [ Time Frame: month 6 ]
  • Evaluation of the minimum of clinical important differences (MCID) [ Time Frame: month 9 ]
Not Provided
Not Provided
 
Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities
Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities
This multicenter, post marketing observational study (PMOS) was designed to evaluate the effectiveness of adalimumab over a period of 9 months as determined by the Psoriasis Area and Severity Index (PASI) in participants with moderate to severe plaque psoriasis with distinct co-morbidities. Secondary objectives of this study were to measure changes in psychological health via the Dermatology Life Quality Index (DLQI); changes in comorbidities with respect to gender; changes in quality of life using the Short Form Health Survey (SF-36); and evaluation of Minimal Clinically Important Differences (MCID).
Male or female participants ages 18 years of age and older for whom the treating physician had recently prescribed adalimumab were included in this study. Adalimumab was prescribed in accordance with the terms of the local marketing authorization with regards to dose, population, and indication. There were 5 planned visits during the study: baseline (Visit 1), 1 month (Visit 2), 3 months (Visit 3), 6 months (Visit 4), and 9 months (Visit 5).
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Hospital, Dermatology
Moderate to Severe Plaque Psoriasis
Not Provided
Participants with psoriasis and at least one co-morbid disease
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
246
May 2016
May 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Participants for whom adalimumab therapy is indicated and has been prescribed according to the product label and who meet the following criteria:

  • Participant age ≥ 18 years
  • Participants with moderate to severe plaque psoriasis participants who have at last 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 (diagnosed by a medical specialist for psychology, neurology, or psychiatry)
  • Adalimumab naïve participants with moderate to severe plaque psoriasis after unsatisfactory response, non tolerability, or contraindication of systemic therapies such as ciclosporin, methotrexate or PUVA ( psoralen + UVA) or after biological disease modifying anti-rheumatic drugs (bDMARDs) failure (e.g.: infliximab, etanercept or ustekinumab)
  • Participants of each country must fulfill any local treatment recommendation for use of bDMARD in psoriasis in their respective country. For Austria: participants must fulfill Austrian Treatment Recommendations for use of bDMARD in psoriasis (Chest X-ray and IGRA* interferon gamma release assay or PPD-skin test negative for tuberculosis)
  • Participant is willing to give informed consent to anonymous data collection and their forwarding to AbbVie as well as to informed consent if required in different countries.
  • Participant must be able and willing to self-administer adalimumab injections or have a qualified person available to administer Humira® syringe or Humira® Pen injections

Exclusion Criteria:

The following participants will not be included in this observational study:

  • Participants who meet contraindications as outlined in the latest version of the Humira syringe® Summary of Product Characteristics (SPC) and Humira Pen® SPC
  • Participants participating in another study program or clinical trial
  • Participants who have been treated with Humira® before
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Austria,   Greece,   Israel,   Portugal
 
NCT01401452
P12-770
No
Not Provided
Plan to Share IPD: No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Raffeiner GmbH
Study Director: AbbVie Inc AbbVie
AbbVie
May 2017