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

Rheumatoid Arthritis Clinical Trial

Official title:

A Multicenter, Prospective, Observational Real World Study For the Efficacy and Safety of a Adalimumab Biosimilar (Geleli) in Rheumatoid Arthritis.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05240859
• Other study ID #: 2022-Z-04
• Status: Not yet recruiting
• Start date: February 22, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: February 2022
• Source: Peking University People's Hospital
• Contact: Ru Li, MD, PhD
• Phone: +86 18611616251
• Email: doctorliru123[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1600
• Est. completion date: August 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Geleli
Adalimumab Biosimilar

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Who Were on Geleli for a Period of 24 Weeks		Week 24
Secondary	Remission rate According to Boolean Criteria		Week 12 and Week 24
Secondary	Remission rate According to Clinical Disease Activity Index (CDAI)		Week 12 and Week 24
Secondary	Proportion of Participants Achieving American College of Rheumatology (ACR) 20		Week 4 and Week 12
Secondary	Proportion of Participants Achieving American College of Rheumatology (ACR) 50		Week 4, Week 12 and Week 24
Secondary	Proportion of Participants Achieving American College of Rheumatology (ACR) 70		Week 4, Week 12 and Week 24
Secondary	Change From Baseline in Disease Activity Score 28 (DAS28)-ESR		Baseline, Week 4, Week12 and Week 24
Secondary	Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)		Baseline, Week 4, Week12 and Week 24
Secondary	Assessment of Safety Based on Adverse Events that Occur During the Study.		24 weeks