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Post Marketing Observational Study on Venezuelan Patients With Psoriasis

26 november 2016 uppdaterad 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.

Studieöversikt

Status

Indragen

Studietyp

Observationell

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Kohorter och interventioner

Grupp / Kohort
Cohort 1

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in PASI 75 (Psoriasis Area and Severity Index score) Response Rate
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean change of PASI score
Tidsram: From week 0 to week 16
From week 0 to week 16
Mean change of DLQI score
Tidsram: From week 0 to week 16
From week 0 to week 16
Changes in Psoriatic Arthritis Response Criteria (PsARC) score
Tidsram: From week 0 to week 16
From week 0 to week 16
Mean change of Hospital Anxiety and Depression Score (HADS)
Tidsram: From week 0 to week 16
From week 0 to week 16
Mean change en Work Productivity and Activity Impairment (WPAI)-Psoriasis score
Tidsram: From week 0 to week 16
From week 0 to week 16
Percentage of subjects with Serious Adverse Events (SAEs)
Tidsram: Up to week 16
Occurrence of SAEs including tuberculosis, other opportunistic infections and cancer
Up to week 16
Discontinuation of adalimumab for any reason.
Tidsram: Up to week 16
Up to week 16

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Studiestol: Natali Serra-Bonett, MD, Abbott

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 februari 2013

Primärt slutförande (Faktisk)

1 mars 2016

Avslutad studie (Faktisk)

1 mars 2016

Studieregistreringsdatum

Först inskickad

26 december 2012

Först inskickad som uppfyllde QC-kriterierna

26 december 2012

Första postat (Uppskatta)

1 januari 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

29 november 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 november 2016

Senast verifierad

1 november 2016

Mer information

Termer relaterade till denna studie

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