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

NCT ID: NCT05240859

Last Updated: 2022-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-22

Study Completion Date

2024-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Geleli

RA patients treated with Geleli

Geleli

Intervention Type DRUG

Adalimumab Biosimilar

Interventions

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Geleli

Adalimumab Biosimilar

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhanguo Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Rheumatology and Immunology, Peking University People's Hospital

Locations

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Peking University People's Hospital

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Ru Li, MD, PhD

Role: CONTACT

+86 18611616251

Facility Contacts

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Zhanguo Li, MD, PhD

Role: primary

+86 88324178

Other Identifiers

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2022-Z-04

Identifier Type: -

Identifier Source: org_study_id

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