Real World Study of a Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis

Peking University

Status

Not yet enrolling

Conditions

Rheumatoid Arthritis

Treatments

Drug: Geleli

Study type

Observational

Funder types

Other

Identifiers

NCT05240859

2022-Z-04

Details and patient eligibility

About

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.

Enrollment

1,600 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.