- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01758705
Post Marketing Observational Study on Venezuelan Patients With Psoriasis
26. november 2016 opdateret af: AbbVie (prior sponsor, Abbott)
Observational Study; Clinical Effectiveness and Impact on Patient Reported Outcomes in Venezuelan Patients With Psoriasis After 16 Weeks of ADA Therapy
The aim of this study is to obtain Venezuelan data of clinical effectiveness, impact in the HRQoL, work productivity and activity impairment in patients with psoriasis using adalimumab.
Studieoversigt
Status
Trukket tilbage
Betingelser
Undersøgelsestype
Observationel
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Subjects male or female with moderate to severe chronic plaque psoriasis with or without psoriatic arthritis.
Patients with history of psoriatic arthritis or articular symptoms must be evaluated by a Rheumatologist.
Beskrivelse
Inclusion Criteria:
- Subjects with moderate to severe chronic plaque psoriasis, with or without psoriatic arthritis, who have the indication for adalimumab because they need systemic therapy or because they have had failure to phototherapy, or to other systemic or topical treatments
- Subjects that are not receiving biologic therapy in the last 12 weeks or classical therapy in the past 4 weeks and/or phototherapy in the last 2 weeks. Topical therapy will be allowed, to a constant dose and will not be used within 24 hours prior to the visit
- Patients under previous treatment with any experimental drug will have a minimum washout period of five half-lives
- Subjects must be capable to understand and willing to give a written informed consent form to release information and to comply with the requirements of the study protocol
Exclusion Criteria:
- Subjects should not be enrolled if they cannot be treated in accordance with the local product label approved in Venezuela
- Subjects enrolled into another study or under treatment with an investigational product
- History of viral hepatitis B infection or HIV
- 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 TB infection before initiating adalimumab treatment or latent TB infection not able to complete prophylactic treatment
- Pregnant or lactating female. Pregnancy will be tested before entering the study in fertile women. Women in fertile age must be advised by the physician, to use a clinically accepted contraceptive method (contraceptive pills, IUDs, barrier devices as condoms or abstinence)
- History of congestive heart failure (CHF)
- Any another condition that according to the criteria of the participating investigator represents an obstacle for study conduction and / or subjects to an unacceptable risks
- Subjects with active infection including chronic or localized infections until infections are controlled
- History of sensitive to latex or other component of the syringe
- Subjects who requires concomitant phototherapy and systemic therapy during adalimumab therapy
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Cohort 1
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in PASI 75 (Psoriasis Area and Severity Index score) Response Rate
Tidsramme: From Week 0 to Week 16
|
From Week 0 to Week 16
|
|
|
Change in Percentage of patients with clinical difference in DLQI (Dermatology Life Quality Index) score
Tidsramme: From Week 0 to Week 16
|
Clinical difference is defined by a minimal important difference (MID) in DLQI score between 2.3-5 at 16 weeks
|
From Week 0 to Week 16
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean change of PASI score
Tidsramme: From week 0 to week 16
|
From week 0 to week 16
|
|
|
Mean change of DLQI score
Tidsramme: From week 0 to week 16
|
From week 0 to week 16
|
|
|
Changes in Psoriatic Arthritis Response Criteria (PsARC) score
Tidsramme: From week 0 to week 16
|
From week 0 to week 16
|
|
|
Mean change of Hospital Anxiety and Depression Score (HADS)
Tidsramme: From week 0 to week 16
|
From week 0 to week 16
|
|
|
Mean change en Work Productivity and Activity Impairment (WPAI)-Psoriasis score
Tidsramme: From week 0 to week 16
|
From week 0 to week 16
|
|
|
Percentage of subjects with Serious Adverse Events (SAEs)
Tidsramme: Up to week 16
|
Occurrence of SAEs including tuberculosis, other opportunistic infections and cancer
|
Up to week 16
|
|
Discontinuation of adalimumab for any reason.
Tidsramme: Up to week 16
|
Up to week 16
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Natali Serra-Bonett, MD, Abbott
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2013
Primær færdiggørelse (Faktiske)
1. marts 2016
Studieafslutning (Faktiske)
1. marts 2016
Datoer for studieregistrering
Først indsendt
26. december 2012
Først indsendt, der opfyldte QC-kriterier
26. december 2012
Først opslået (Skøn)
1. januar 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
29. november 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. november 2016
Sidst verificeret
1. november 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- P13-709
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .