Effectiveness and Adherence of Golimumab in Rheumatoid Arthritis

Sponsor
Peking Union Medical College Hospital
Study ID
NCT04188249
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Golimumab — 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.

Study Details

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.

Key Dates

Start date
Jul 1, 2019
Status verified
Jun 2019
Primary completion
Mar 1, 2021
Completion
Mar 1, 2021

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: 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

Primary Outcome Measure

Percentage of low disease activity (CDAI) at week 12 [ Time Frame: At week 12 ]

Central Contacts

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