- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01758705
Post Marketing Observational Study on Venezuelan Patients With Psoriasis
26. november 2016 oppdatert av: 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.
Studieoversikt
Status
Tilbaketrukket
Studietype
Observasjonsmessig
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
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Cohort 1
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Natali Serra-Bonett, MD, Abbott
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. februar 2013
Primær fullføring (Faktiske)
1. mars 2016
Studiet fullført (Faktiske)
1. mars 2016
Datoer for studieregistrering
Først innsendt
26. desember 2012
Først innsendt som oppfylte QC-kriteriene
26. desember 2012
Først lagt ut (Anslag)
1. januar 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
29. november 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. november 2016
Sist bekreftet
1. november 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- P13-709
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .