Effectiveness and Adherence of Golimumab in Rheumatoid Arthritis

A Prospective Multicenter Registry of Golimumab in Chinese Patients With Rheumatoid Arthritis

Patrocinadores

Patrocinador principal: Peking Union Medical College Hospital

Fuente Peking Union Medical College Hospital
Resumen breve

This will be a prospective, observational, single-arm, registry study based on data received from Chinese Registry of rheumatoid arthritis (CREDIT) database to register 200 Chinese RA patients treated with golimumab in one year. Patient characteristic, clinical effectiveness and drug adherence of golimumab will be evaluated.

Descripción detallada

This multicenter (12 centers), prospective program will register 200 RA patients routinely receiving golimumab treatment. Doctor will record the disease evaluation, concomitant drug, adverse events and laboratory tests based on patient's visit till they withdraw from clinical visit. Doctor will still collect above information whether patient interrupt or stop golimumab till the end of program or patient withdraw permanently.

Estado general Recruiting
Fecha de inicio July 1, 2019
Fecha de Terminación March 1, 2021
Fecha de finalización primaria March 1, 2021
Tipo de estudio Observational
Resultado primario
Medida Periodo de tiempo
Percentage of low disease activity (CDAI) at week 12 At week 12
Percentage of remission (CDAI) at week 12 At week 12
Resultado secundario
Medida Periodo de tiempo
Percentage of low disease activity (DAS28-CRP) at week 12 March 1, 2021
Patient disease activity assessment (VAS) at week 12 at week 12
Patient Pain Global assessment (VAS) at week 12 at week 12
Function evaluation at week 12 at week 12
Medication possession rate (MPR) at week 12 at week 12
Medication possession rate (MPR) at week 24 at week 24
Medication possession rate (MPR) at week 48 at week 48
Inscripción 200
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Golimumab

Descripción: This multicenter (12 centers), prospective program will register 200 RA patients routinely receiving golimumab treatment. Doctor will record the disease evaluation, concomitant drug, adverse events and laboratory tests based on patient's visit till they withdraw from clinical visit. Doctor will still collect above information whether patient interrupt or stop golimumab till the end of program or patient withdraw permanently.

Etiqueta de grupo de brazo: RA patients

Elegibilidad

Método de muestreo: Non-Probability Sample

Criterios:

Inclusion Criteria:

- - 18 years and older

- Fulfil the ACR/EULAR classification criteria for RA in 2010

- Patients able to understand and complete self-evaluation questionnaires.

Exclusion Criteria:

- - Contraindications for golimumab

- Prior exposure to TNFi/JAKi

Género: All

Edad mínima: 18 Years

Edad máxima: 80 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Xiaofeng Zeng, M.D. Principal Investigator Peking Union Medical College Hospital
Contacto general

Apellido: Nan Jiang, M.D.

Teléfono: +86 13683278877

Email: [email protected]

Ubicación
Instalaciones: Estado: Peking Union Medical College Hospital
Ubicacion Paises

China

Fecha de verificación

June 2019

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Condición Examinar
Grupo de brazo

Etiqueta: RA patients

Descripción: Patients (or a representative) must provide informed consent before any procedures occur. Main Inclusion Criteria: 18 years and older Fulfil the ACR/EULAR classification criteria for RA in 2010 Patients able to understand and complete self-evaluation questionnaires. General Exclusion Criteria: Contraindications for golimumab Prior exposure to TNFi/JAKi

Información de diseño del estudio

Modelo de observación: Cohort

Perspectiva de tiempo: Prospective

Fuente: ClinicalTrials.gov