Effectiveness and Adherence of Golimumab in Rheumatoid Arthritis

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

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.

Study Overview

• Status: Unknown
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Drug: Golimumab

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Nan Jiang, M.D.; Phone Number: +86 13683278877; Email: jn_pumc@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

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

RA patients; Patients (or a representative) must provide informed consent before any procedures occur.; Main Inclusion Criteria:18 years and olderFulfil the ACR/EULAR classification criteria for RA in 2010Patients able to understand and complete self-evaluation questionnaires.; General Exclusion Criteria:Contraindications for golimumabPrior exposure to TNFi/JAKi

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Percentage of remission (CDAI) at week 12	Remission is defined as crohn's disease activity index (CDAI)≤ 2.8.	At week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Patient disease activity assessment (VAS) at week 12	based on a scale of 0=no disease to 10=severe disease	at week 12
Patient Pain Global assessment (VAS) at week 12	based on a scale of 0=no disease to 10=severe disease	at week 12
Function evaluation at week 12	Health Assessment Questionnaire Disability Index (HAQ-DI) for function evaluation	at week 12
Medication possession rate (MPR) at week 12		at week 12
Medication possession rate (MPR) at week 24		at week 24
Medication possession rate (MPR) at week 48		at week 48

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 5, 2019

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 3, 2019
• Last Verified: June 1, 2019

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; Physiological Effects of Drugs; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Tumor Necrosis Factor Inhibitors; Golimumab
• Other Study ID Numbers: CNTO148ARA4012

Drug and device information, study documents

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