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LAPIS-PsA

Study of Apremilast Use in Patients With Psoriatic Arthritic in Practice Conditions

Ensayo de AMGEN INC en Arthritis, Psoriatic (del registro, en inglés).

Fase

no aplica

Estado

Completado

Participantes

526

previstos

Centros

2

Fin del objetivo primario

jul 2018

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en feb 2016.

Qué mide

Percentage of patients with an improvement of ≥ 1 points on the Physician's Global Assessment (PGA) scale on visit 3 compared to baseline on the Physician's Global Assessment scale (PGA; scale from 0-4) (del registro, en inglés) (hasta unos 7 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroA total of approximately 500 patients with active psoriatic arthritis in an estimated 80 to 100 trial centers are to be enrolled. Selection of centers will be made by the sponsor's medical section. To increase the quality of the data and to reduce distribution of the data collected, centers to be included will be those which can enroll at least 5 patients. Care will be taken to ensure a balanced regional distribution. The proposed observation period for the trial is approx. 52 weeks per patient. Estimated patient enrolment is also 52 weeks. The duration of the follow-up period will be extended from approx. 52 weeks to approx. 100 weeks to gain further information about the long-term use of Otezla®. For this extension of the follow-up period 2 new visits (visits 6 and 7) are proposed.Thus, proposed duration from first patient in (FPI) to last patient out (LPO) is 36 months-

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Ficha completa en ClinicalTrials.gov (NCT03106051), actualizada en sep 2025.