Effectiveness and Adherence of Golimumab in Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

Official title:

A Prospective Multicenter Registry of Golimumab in Chinese Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04188249
• Other study ID #: CNTO148ARA4012
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: June 2019
• Source: Peking Union Medical College Hospital
• Contact: Nan Jiang, M.D.
• Phone: +86 13683278877
• Email: jn_pumc[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of low disease activity (CDAI) at week 12	Low disease activity is defined as crohn's disease activity index (CDAI)= 10.	At week 12
Primary	Percentage of remission (CDAI) at week 12	Remission is defined as crohn's disease activity index (CDAI)= 2.8.	At week 12
Secondary	Percentage of low disease activity (DAS28-CRP) at week 12	Low disease activity is defined as DAS28-CRP score = 2.6 but = 3.2	March 1, 2021
Secondary	Patient disease activity assessment (VAS) at week 12	based on a scale of 0=no disease to 10=severe disease	at week 12
Secondary	Patient Pain Global assessment (VAS) at week 12	based on a scale of 0=no disease to 10=severe disease	at week 12
Secondary	Function evaluation at week 12	Health Assessment Questionnaire Disability Index (HAQ-DI) for function evaluation	at week 12
Secondary	Medication possession rate (MPR) at week 12		at week 12
Secondary	Medication possession rate (MPR) at week 24		at week 24
Secondary	Medication possession rate (MPR) at week 48		at week 48