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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Geleli

• Study Type: Observational
• Enrollment (Anticipated): 1600

Contacts and Locations

• Study Contact: Name: Ru Li, MD, PhD; Phone Number: +86 18611616251; Email: doctorliru123@163.com

Study Locations

• China
  • Beijing, China, 100044
    • Peking University People's Hospital
    • Contact: Zhanguo Li, MD, PhD; Phone Number: +86 88324178; Email: li99@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

RA patients who start Geleli treatment

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Geleli; RA patients treated with Geleli	Drug: Geleli; Adalimumab Biosimilar

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Proportion of Participants Achieving American College of Rheumatology (ACR) 70	Week 4, Week 12 and Week 24
Change From Baseline in Disease Activity Score 28 (DAS28)-ESR	Baseline, Week 4, Week12 and Week 24
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)	Baseline, Week 4, Week12 and Week 24
Assessment of Safety Based on Adverse Events that Occur During the Study.	24 weeks

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Zhanguo Li, MD, PhD, Department of Rheumatology and Immunology, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 22, 2022
• Primary Completion (Anticipated): February 28, 2024
• Study Completion (Anticipated): August 30, 2024

Study Registration Dates

• First Submitted: February 6, 2022
• First Submitted That Met QC Criteria: February 6, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 6, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 2022-Z-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No