Effectiveness and Adherence of Golimumab in Rheumatoid Arthritis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Drug: Golimumab
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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 disease activity assessment (VAS) at week 12 [at week 12]
based on a scale of 0=no disease to 10=severe disease
- 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]
- Medication possession rate (MPR) at week 48 [at week 48]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | Beijing | China |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Principal Investigator: Xiaofeng Zeng, M.D., Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CNTO148ARA4012