Real World Study of a Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: Geleli
- Registration Number
- NCT05240859
- Lead Sponsor
- Peking University People's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1600
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Geleli Geleli RA patients treated with Geleli
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Proportion of Participants Achieving American College of Rheumatology (ACR) 20 Week 4 and Week 12 Remission rate According to Clinical Disease Activity Index (CDAI) Week 12 and Week 24 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 Change From Baseline in Disease Activity Score 28 (DAS28)-ESR Baseline, Week 4, Week12 and Week 24 Assessment of Safety Based on Adverse Events that Occur During the Study. 24 weeks Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Baseline, Week 4, Week12 and Week 24 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
Trial Locations
- Locations (1)
Peking University People's Hospital
🇨🇳Beijing, China