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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

perjantai 8. elokuuta 2014 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Lopetettu

Ehdot

Keskivaikea tai vaikea psoriaasi

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Todellinen)

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Sukupuolet, jotka voivat opiskella

Kaikki

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

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

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Ryhmien/kohorttien lukumäärä

Kohortit ja interventiot

Ryhmä/Kohortti
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.

Ryhmä/Kohortti

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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus	Toimenpiteen kuvaus	Aikaikkuna
Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response Aikaikkuna: 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 Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus	Toimenpiteen kuvaus	Aikaikkuna
European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16 Aikaikkuna: 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) Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

AbbVie (prior sponsor, Abbott)

Tutkijat

Opintojohtaja: Manuel Uribe, MD, AbbVie

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Hyödyllisiä linkkejä

Related Info

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.

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