Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy
8 agosto 2014 aggiornato da: AbbVie (prior sponsor, Abbott)
Observational Study; Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy
Adalimumab has recently been authorized for active psoriasis in Peru and local experience is very low.
The aim of this study is to obtain Peruvian data of clinical effectiveness and impact on health-related quality of life with the use of adalimumab in participants with chronic plaque psoriasis complying with the dosing and monitoring recommendations of the local approved label.
Panoramica dello studio
Stato
Terminato
Condizioni
Tipo di studio
Osservativo
Iscrizione (Effettivo)
30
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Lima, Perù
- Site Reference ID/Investigator# 35783
-
Lima, Perù
- Site Reference ID/Investigator# 56700
-
Trujillo, Perù
- Site Reference ID/Investigator# 43147
-
-
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
Participants with moderate to severe psoriasis who receive adalimumab therapy according to standard clinical practice at Peruvian hospitals/clinics.
Descrizione
Inclusion Criteria:
- Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate
- Participant is capable of and willing to give written informed consent and to comply with the requirements of the study protocol
Exclusion Criteria:
- Participants should not be enrolled if they cannot be treated in accordance with the local product label
- Participants enrolled into another study or clinical trial
- History of hepatitis B infection
- History of neurologic symptoms suggestive of central nervous system demyelinating disease
- History of cancer or lymphoproliferative disease (other than successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix)
- Active tuberculosis infection before initiating adalimumab treatment or latent tuberculosis infection not able to take complete prophylactic treatment
- Pregnant or lactating female, demonstrated by a pregnancy test before entering the study and willing to use a contraceptive method
- Use of another anti-tumoral necrosis factor previously
- History of congestive heart failure
- Any other condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or subjects participants to an unacceptable risk
- Participants with active infection including chronic or localized infections until infections are controlled
- History of sensitivity to latex
- Participants who will receive concomitant phototherapy and systemic therapy during adalimumab therapy
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
Coorti e interventi
Gruppo / Coorte |
|---|
|
Adalimumab Treatment in Participants with Psoriasis
Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response
Lasso di tempo: Baseline to Week 16
|
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-75 responders are the participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16.
The mean PASI improvement was calculated using a linear regression model.
|
Baseline to Week 16
|
|
Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score
Lasso di tempo: Baseline to Week 16
|
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, 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.
MID for the DLQI was defined as a score decrease from baseline of 2.3 to 5. The mean DLQI improvement was calculated using a linear regression model.
|
Baseline to Week 16
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16
Lasso di tempo: Baseline, Week 16
|
EQ-5D is a self-reported health outcome which measures mobility, self-care, usual activities, pain discomfort, anxiety, and depression.
An overall score is derived that measures from -0.59 (worst) to +1 (best).
Improvement was defined as a mean score increase of at least 0.2.
|
Baseline, Week 16
|
|
Number of Participants With Serious Adverse Events (SAEs)
Lasso di tempo: From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).
|
An adverse event was considered an SAE if it met any of the following criteria: death of the participant; life-threatening event; hospitalization; prolongation of hospitalization; congenital anomaly; persistent or significant disability/incapacity; an important medical event requiring medical or surgical intervention to prevent serious outcome; spontaneous or elective abortion.
SAEs included the occurrence of tuberculosis, opportunistic infection, and malignancy.
|
From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).
|
|
Adherence to Adalimumab Treatment
Lasso di tempo: up to 16 weeks
|
Adherence was measured by how many times a participant had a discontinuation (i.e., missed a study dose) during the 16 weeks of treatment.
|
up to 16 weeks
|
|
Mean Psoriasis Area and Severity Index (PASI) Score Over Time
Lasso di tempo: Baseline, Week 4, Week 8, Week 16
|
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).
The mean PASI improvement was calculated using a linear regression model.
|
Baseline, Week 4, Week 8, Week 16
|
|
Mean Dermatology Life Quality Index (DLQI) Score Over Time
Lasso di tempo: Baseline, Week 4, Week 8, Week 16
|
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, 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.
The mean DLQI improvement was calculated using a linear regression model.
|
Baseline, Week 4, Week 8, Week 16
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Manuel Uribe, MD, AbbVie
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
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 novembre 2010
Completamento primario (Effettivo)
1 agosto 2013
Completamento dello studio (Effettivo)
1 agosto 2013
Date di iscrizione allo studio
Primo inviato
1 luglio 2010
Primo inviato che soddisfa i criteri di controllo qualità
1 luglio 2010
Primo Inserito (Stima)
5 luglio 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
25 agosto 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
8 agosto 2014
Ultimo verificato
1 agosto 2014
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P12-261
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 .