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- Klinische proef NCT01156532
Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy
8 augustus 2014 bijgewerkt door: 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.
Studie Overzicht
Toestand
Beëindigd
Conditie
Studietype
Observationeel
Inschrijving (Werkelijk)
30
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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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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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
Participants with moderate to severe psoriasis who receive adalimumab therapy according to standard clinical practice at Peruvian hospitals/clinics.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline, Week 4, Week 8, Week 16
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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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Manuel Uribe, MD, AbbVie
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 november 2010
Primaire voltooiing (Werkelijk)
1 augustus 2013
Studie voltooiing (Werkelijk)
1 augustus 2013
Studieregistratiedata
Eerst ingediend
1 juli 2010
Eerst ingediend dat voldeed aan de QC-criteria
1 juli 2010
Eerst geplaatst (Schatting)
5 juli 2010
Updates van studierecords
Laatste update geplaatst (Schatting)
25 augustus 2014
Laatste update ingediend die voldeed aan QC-criteria
8 augustus 2014
Laatst geverifieerd
1 augustus 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- P12-261
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .