- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01758705
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
Betingelser
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.
Sponsor
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
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P13-709
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .