Rheumatoid Arthritis
Conditions
Brief summary
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.
Interventions
DRUGGeleli
Adalimumab Biosimilar
Sponsors
Peking University People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants who fulfilled the 1987 revised American College of Rheumatology (ACR) or 2010 ACR/EULAR classification criteria for RA. * Participants for whom the rheumatologists have decided to initiate Geleli treatment. * Participants who provide a written informed consent form of participating in this study.
Exclusion criteria
* Current active or chronic infections, or previous history of active TB infection. * History of malignancy. * Congestive heart failure with NYHA class III or IV. * Females of childbearing or breastfeeding. * Participate in other clinical trial within 3 months. * Allergic to the drugs involved in the study. * The investigator believes that the patient is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving American College of Rheumatology (ACR) 20 | Week 24 | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Proportion of Participants Achieving American College of Rheumatology (ACR) 50 | Week 4, Week 12 and Week 24 |
| Remission rate According to Boolean Criteria | Week 12 and Week 24 |
| Remission rate According to Clinical Disease Activity Index (CDAI) | Week 12 and Week 24 |
| Proportion of Participants Achieving American College of Rheumatology (ACR) 20 | Week 4 and Week 12 |
| Percentage of Participants Who Were on Geleli for a Period of 24 Weeks | Week 24 |
Countries
China
Contacts
Primary ContactRu Li, MD, PhD
Outcome results
None listed