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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RA patients | Patients (or a representative) must provide informed consent before any procedures occur.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Golimumab | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nan Jiang, M.D. | Contact | +86 13683278877 | jn_pumc@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaofeng Zeng, M.D. | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C529000 | golimumab |
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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 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |