Status:
UNKNOWN
Real World Study of a Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis
Lead Sponsor:
Peking University People's Hospital
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 22 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 30 2024
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT05240859
Start Date
February 22 2022
End Date
August 30 2024
Last Update
February 15 2022
Active Locations (1)
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1
Peking University People's Hospital
Beijing, China, 100044