Effectiveness of Adalimumab in Moderate to Severe Plaque Psoriasis Patients With Distinct Co-morbidities (EPIC)
12 maggio 2017 aggiornato da: 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).
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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).
Tipo di studio
Osservativo
Iscrizione (Effettivo)
246
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Hospital, Dermatology
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mean Dermatology Life Quality Index (DLQI) Scores
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
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Sponsor
Collaboratori
Pubblicazioni e link utili
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Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2011
Completamento primario (Effettivo)
1 maggio 2016
Completamento dello studio (Effettivo)
1 maggio 2016
Date di iscrizione allo studio
Primo inviato
1 luglio 2011
Primo inviato che soddisfa i criteri di controllo qualità
22 luglio 2011
Primo Inserito (Stima)
25 luglio 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
4 ottobre 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 maggio 2017
Ultimo verificato
1 maggio 2017
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P12-770
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .