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.
Study Type
OBSERVATIONAL
Enrollment
1,600
Adalimumab Biosimilar
Peking University People's Hospital
Beijing, China
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.
Time frame: Week 24
Percentage of Participants Who Were on Geleli for a Period of 24 Weeks
Time frame: Week 24
Remission rate According to Boolean Criteria
Time frame: Week 12 and Week 24
Remission rate According to Clinical Disease Activity Index (CDAI)
Time frame: Week 12 and Week 24
Proportion of Participants Achieving American College of Rheumatology (ACR) 20
Time frame: Week 4 and Week 12
Proportion of Participants Achieving American College of Rheumatology (ACR) 50
Time frame: Week 4, Week 12 and Week 24
Proportion of Participants Achieving American College of Rheumatology (ACR) 70
Time frame: Week 4, Week 12 and Week 24
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR
Time frame: Baseline, Week 4, Week12 and Week 24
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: Baseline, Week 4, Week12 and Week 24
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Assessment of Safety Based on Adverse Events that Occur During the Study.
Time frame: 24 weeks