A Prospective Multicenter Registry of Golimumab in Chinese Patients With Rheumatoid Arthritis
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Percentage of remission (CDAI) at week 12
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
RA patients
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
Intervention: Golimumab (Drug)
Outcomes
Primary Outcomes
Percentage of remission (CDAI) at week 12
Time Frame: At week 12
Remission is defined as crohn's disease activity index (CDAI)≤ 2.8.
Percentage of low disease activity (CDAI) at week 12
Time Frame: At week 12
Low disease activity is defined as crohn's disease activity index (CDAI)≤ 10.
Secondary Outcomes
- Medication possession rate (MPR) at week 48(at week 48)
- Patient disease activity assessment (VAS) at week 12(at week 12)
- Patient Pain Global assessment (VAS) at week 12(at week 12)
- Percentage of low disease activity (DAS28-CRP) at week 12(March 1, 2021)
- 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)