Real World Study of a Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis
A Multicenter, Prospective, Observational Real World Study For the Efficacy and Safety of a Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis.
1 other identifier
observational
1,600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2022
CompletedFirst Posted
Study publicly available on registry
February 15, 2022
CompletedStudy Start
First participant enrolled
February 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2024
CompletedFebruary 15, 2022
February 1, 2022
2 years
February 6, 2022
February 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Week 24
Secondary Outcomes (9)
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
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
Proportion of Participants Achieving American College of Rheumatology (ACR) 50
Week 4, Week 12 and Week 24
- +4 more secondary outcomes
Study Arms (1)
Geleli
RA patients treated with Geleli
Interventions
Eligibility Criteria
RA patients who start Geleli treatment
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, 100044, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhanguo Li, MD, PhD
Department of Rheumatology and Immunology, Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2022
First Posted
February 15, 2022
Study Start
February 22, 2022
Primary Completion
February 28, 2024
Study Completion
August 30, 2024
Last Updated
February 15, 2022
Record last verified: 2022-02