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The purpose of this multicenter, prospective, Observational study is to assess the Efficacy and Safety of an Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis in the real world setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Geleli | RA patients treated with Geleli |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geleli | Drug | Adalimumab Biosimilar |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Achieving American College of Rheumatology (ACR) 20 | The ACR20 was achieved if there was at least a 20% improvement from baseline in swollen joint count 66 (SJC66) and tender joint count 68 (TJC68) and 3 or more of the 5 following assessments: participant's assessment of pain, GH, physician's global assessment of disease activity, participant's assessment of physical function and CRP. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Were on Geleli for a Period of 24 Weeks | Week 24 | |
| Remission rate According to Boolean Criteria | Week 12 and Week 24 | |
| Remission rate According to Clinical Disease Activity Index (CDAI) |
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Inclusion Criteria:
Exclusion Criteria:
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RA patients who start Geleli treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ru Li, MD, PhD | Contact | +86 18611616251 | doctorliru123@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhanguo Li, MD, PhD | Department of Rheumatology and Immunology, Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | 100044 | 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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| Week 12 and Week 24 |
| Proportion of Participants Achieving American College of Rheumatology (ACR) 20 | Week 4 and Week 12 |
| Proportion of Participants Achieving American College of Rheumatology (ACR) 50 | Week 4, Week 12 and Week 24 |
| Proportion of Participants Achieving American College of Rheumatology (ACR) 70 | Week 4, Week 12 and Week 24 |
| Change From Baseline in Disease Activity Score 28 (DAS28)-ESR | Baseline, Week 4, Week12 and Week 24 |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | Baseline, Week 4, Week12 and Week 24 |
| Assessment of Safety Based on Adverse Events that Occur During the Study. | 24 weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |