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

Peking University People's Hospital1 site in 1 country1,600 target enrollmentFebruary 22, 2022

ConditionsRheumatoid Arthritis

InterventionsGeleli

DrugsGeleli

Overview

Phase: N/A
Intervention: Geleli
Conditions: Rheumatoid Arthritis
Sponsor: Peking University People's Hospital
Enrollment: 1600
Locations: 1
Primary Endpoint: Proportion of Participants Achieving American College of Rheumatology (ACR) 20
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 22, 2022

End Date

August 30, 2024

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Peking University People's Hospital

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Geleli

RA patients treated with Geleli

Intervention: Geleli

Outcomes

Primary Outcomes

Proportion of Participants Achieving American College of Rheumatology (ACR) 20

Time Frame: 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 Outcomes

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)