Post Marketing Observational Study on Venezuelan Patients With Psoriasis
Observational Study; Clinical Effectiveness and Impact on Patient Reported Outcomes in Venezuelan Patients With Psoriasis After 16 Weeks of ADA Therapy
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Tipo de estudio
Tipo de estudio
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
|---|
|
Cohort 1
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in PASI 75 (Psoriasis Area and Severity Index score) Response Rate
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean change of PASI score
Periodo de tiempo: From week 0 to week 16
|
From week 0 to week 16
|
|
|
Mean change of DLQI score
Periodo de tiempo: From week 0 to week 16
|
From week 0 to week 16
|
|
|
Changes in Psoriatic Arthritis Response Criteria (PsARC) score
Periodo de tiempo: From week 0 to week 16
|
From week 0 to week 16
|
|
|
Mean change of Hospital Anxiety and Depression Score (HADS)
Periodo de tiempo: From week 0 to week 16
|
From week 0 to week 16
|
|
|
Mean change en Work Productivity and Activity Impairment (WPAI)-Psoriasis score
Periodo de tiempo: From week 0 to week 16
|
From week 0 to week 16
|
|
|
Percentage of subjects with Serious Adverse Events (SAEs)
Periodo de tiempo: Up to week 16
|
Occurrence of SAEs including tuberculosis, other opportunistic infections and cancer
|
Up to week 16
|
|
Discontinuation of adalimumab for any reason.
Periodo de tiempo: Up to week 16
|
Up to week 16
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Silla de estudio: Natali Serra-Bonett, MD, Abbott
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- P13-709
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