Effectiveness and Adherence of Golimumab in Rheumatoid Arthritis

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Golimumab

Study type: Observational

Funder types: Other

Identifiers

NCT04188249

CNTO148ARA4012

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

RA patients

Description:

Patients (or a representative) must provide informed consent before any procedures occur. 1. 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. 2. General Exclusion Criteria: * Contraindications for golimumab * Prior exposure to TNFi/JAKi

Treatment:

Drug: Golimumab