Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy
8. august 2014 oppdatert av: 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.
Studieoversikt
Status
Avsluttet
Forhold
Studietype
Observasjonsmessig
Registrering (Faktiske)
30
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Lima, Peru
- Site Reference ID/Investigator# 35783
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Lima, Peru
- Site Reference ID/Investigator# 56700
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Trujillo, Peru
- Site Reference ID/Investigator# 43147
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Participants with moderate to severe psoriasis who receive adalimumab therapy according to standard clinical practice at Peruvian hospitals/clinics.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response
Tidsramme: Baseline to Week 16
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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.
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Baseline to Week 16
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Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score
Tidsramme: Baseline to Week 16
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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.
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Baseline to Week 16
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16
Tidsramme: Baseline, Week 16
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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.
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Baseline, Week 16
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Number of Participants With Serious Adverse Events (SAEs)
Tidsramme: From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).
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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.
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From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).
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Adherence to Adalimumab Treatment
Tidsramme: up to 16 weeks
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Adherence was measured by how many times a participant had a discontinuation (i.e., missed a study dose) during the 16 weeks of treatment.
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up to 16 weeks
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Mean Psoriasis Area and Severity Index (PASI) Score Over Time
Tidsramme: Baseline, Week 4, Week 8, Week 16
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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.
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Baseline, Week 4, Week 8, Week 16
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Mean Dermatology Life Quality Index (DLQI) Score Over Time
Tidsramme: 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.
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Baseline, Week 4, Week 8, Week 16
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Manuel Uribe, MD, AbbVie
Publikasjoner og nyttige lenker
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Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2010
Primær fullføring (Faktiske)
1. august 2013
Studiet fullført (Faktiske)
1. august 2013
Datoer for studieregistrering
Først innsendt
1. juli 2010
Først innsendt som oppfylte QC-kriteriene
1. juli 2010
Først lagt ut (Anslag)
5. juli 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
25. august 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. august 2014
Sist bekreftet
1. august 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P12-261
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