Arthritis, Rheumatoid
Conditions
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.
Interventions
DRUGGolimumab
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.
Sponsors
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Percentage of remission (CDAI) at week 12 | At week 12 | Remission is defined as crohn's disease activity index (CDAI)≤ 2.8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Medication possession rate (MPR) at week 24 | at week 24 | — |
| Medication possession rate (MPR) at week 48 | at week 48 | — |
| Medication possession rate (MPR) at week 12 | at week 12 | — |
| Patient disease activity assessment (VAS) at week 12 | at week 12 | based on a scale of 0=no disease to 10=severe disease |
Countries
China
Contacts
Primary ContactNan Jiang, M.D.
Outcome results
None listed