Effectiveness and Adherence of Golimumab in Rheumatoid Arthritis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Drug: Golimumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RA patients<br>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 | Drug: Golimumab<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of low disease activity (CDAI) at week 12 | Low disease activity is defined as crohn's disease activity index (CDAI)≤ 10. | At week 12 | 
| Percentage of remission (CDAI) at week 12 | Remission is defined as crohn's disease activity index (CDAI)≤ 2.8. | At week 12 | 

Secondary Outcome Measures

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