Effectiveness and Adherence of Golimumab in Rheumatoid Arthritis

NCT ID: NCT04188249

Last Updated: 2019-12-05

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-03-01

Brief Summary

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This will be a prospective, observational, single-arm, registry study based on data received from Chinese Registry of rheumatoid arthritis (CREDIT) database to register 200 Chinese RA patients treated with golimumab in one year. Patient characteristic, clinical effectiveness and drug adherence of golimumab will be evaluated.

Detailed Description

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This multicenter (12 centers), prospective program will register 200 RA patients routinely receiving golimumab treatment. Doctor will record the disease evaluation, concomitant drug, adverse events and laboratory tests based on patient's visit till they withdraw from clinical visit. Doctor will still collect above information whether patient interrupt or stop golimumab till the end of program or patient withdraw permanently.

Conditions

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Arthritis, Rheumatoid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RA patients

Patients (or a representative) must provide informed consent before any procedures occur.

1. Main Inclusion Criteria:

* 18 years and older
* Fulfil the ACR/EULAR classification criteria for RA in 2010
* Patients able to understand and complete self-evaluation questionnaires.
2. General Exclusion Criteria:

* Contraindications for golimumab
* Prior exposure to TNFi/JAKi

Golimumab

Intervention Type DRUG

This multicenter (12 centers), prospective program will register 200 RA patients routinely receiving golimumab treatment. Doctor will record the disease evaluation, concomitant drug, adverse events and laboratory tests based on patient's visit till they withdraw from clinical visit. Doctor will still collect above information whether patient interrupt or stop golimumab till the end of program or patient withdraw permanently.

Interventions

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Golimumab

This multicenter (12 centers), prospective program will register 200 RA patients routinely receiving golimumab treatment. Doctor will record the disease evaluation, concomitant drug, adverse events and laboratory tests based on patient's visit till they withdraw from clinical visit. Doctor will still collect above information whether patient interrupt or stop golimumab till the end of program or patient withdraw permanently.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* \- 18 years and older
* Fulfil the ACR/EULAR classification criteria for RA in 2010
* Patients able to understand and complete self-evaluation questionnaires.

Exclusion Criteria

* \- Contraindications for golimumab
* Prior exposure to TNFi/JAKi
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaofeng Zeng, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Nan Jiang, M.D.

Role: CONTACT

+86 13683278877

Other Identifiers

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CNTO148ARA4012

Identifier Type: -

Identifier Source: org_study_id

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