Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities (EPIC)
12. května 2017 aktualizováno: AbbVie (prior sponsor, Abbott)
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).
Přehled studie
Postavení
Dokončeno
Detailní popis
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).
Typ studie
Pozorovací
Zápis (Aktuální)
246
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
Hospital, Dermatology
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Budoucí
Kohorty a intervence
Skupina / kohorta |
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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
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentage of Participants Achieving a Psoriasis Area and Severity Index 75 (PASI 75) Response at Months 1, 3, 6, and 9
Časové okno: 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.
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Baseline, Months 1, 3, 6, and 9
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Mean Dermatology Life Quality Index (DLQI) Scores
Časové okno: 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.
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Baseline, Months 1, 3, 6, and 9
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Percentage of Participants Achieving a Psoriasis Area and Severity Index 50 (PASI 50) Response at Months 1, 3, 6, and 9
Časové okno: 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.
|
Baseline, Months 1, 3, 6, and 9
|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 90 (PASI 90) Response at Months 1, 3, 6, and 9
Časové okno: 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.
|
Baseline, Months 1, 3, 6, and 9
|
|
Percentage of Participants Achieving a Psoriasis Area and Severity Index 100 (PASI 100) Response at Months 1, 3, 6, and 9
Časové okno: 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.
|
Baseline, Months 1, 3, 6, and 9
|
|
Mean Health Assessment Questionnaire Short Form 36 (SF-36) Physical Component Summary (PCS) Scores at 1, 3, 6, and 9 Months
Časové okno: 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.
|
Baseline, Months 1, 3, 6, and 9
|
|
Mean Health Assessment Questionnaire Short Form 36 (SF-36) Mental Component Summary (MCS) Scores at 1, 3, 6, and 9 Months
Časové okno: 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.
|
Baseline, Months 1, 3, 6, and 9
|
|
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
Časové okno: 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.
|
Baseline, Months 1, 3, 6, and 9
|
|
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
Časové okno: 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.
|
Baseline, Months 1, 3, 6, and 9
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. srpna 2011
Primární dokončení (Aktuální)
1. května 2016
Dokončení studie (Aktuální)
1. května 2016
Termíny zápisu do studia
První předloženo
1. července 2011
První předloženo, které splnilo kritéria kontroly kvality
22. července 2011
První zveřejněno (Odhad)
25. července 2011
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
4. října 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
12. května 2017
Naposledy ověřeno
1. května 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- P12-770
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Ne
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