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Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy

8 sierpnia 2014 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Umiarkowana do ciężkiej łuszczycy

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Peru
- - Lima, Peru
    - Site Reference ID/Investigator# 35783
  - Lima, Peru
    - Site Reference ID/Investigator# 56700
  - Trujillo, Peru
    - Site Reference ID/Investigator# 43147

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

Participants with moderate to severe psoriasis who receive adalimumab therapy according to standard clinical practice at Peruvian hospitals/clinics.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Liczba grup / kohort

Kohorty i interwencje

Grupa / Kohorta
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.

Grupa / Kohorta

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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response Ramy czasowe: 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 Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16 Ramy czasowe: 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) Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

AbbVie (prior sponsor, Abbott)

Śledczy

Dyrektor Studium: Manuel Uribe, MD, AbbVie

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Related Info

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 listopada 2010

Zakończenie podstawowe (Rzeczywisty)

1 sierpnia 2013

Ukończenie studiów (Rzeczywisty)