Effectiveness and Adherence of Golimumab in Rheumatoid Arthritis

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: Golimumab

• Registration Number: NCT04188249
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-27
• Study Start: 2019-07-01
• Study First Submitted QC: 2019-12-03
• Last Update Submitted: 2019-12-03
• Study First Posted: 2019-12-05
• Last Update Posted: 2019-12-05
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RA patients	Golimumab	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

Primary Outcome Measures

Name	Time	Method
Percentage of remission (CDAI) at week 12	At week 12	Remission is defined as crohn's disease activity index (CDAI)≤ 2.8.
Percentage of low disease activity (CDAI) at week 12	At week 12	Low disease activity is defined as crohn's disease activity index (CDAI)≤ 10.

Secondary Outcome Measures

Name	Time	Method
Medication possession rate (MPR) at week 48	at week 48
Patient disease activity assessment (VAS) at week 12	at week 12	based on a scale of 0=no disease to 10=severe disease
Percentage of low disease activity (DAS28-CRP) at week 12	March 1, 2021	Low disease activity is defined as DAS28-CRP score ≥ 2.6 but ≤ 3.2
Patient Pain Global assessment (VAS) at week 12	at week 12	based on a scale of 0=no disease to 10=severe disease
Function evaluation at week 12	at week 12	Health Assessment Questionnaire Disability Index (HAQ-DI) for function evaluation
Medication possession rate (MPR) at week 12	at week 12
Medication possession rate (MPR) at week 24	at week 24

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China