Effectiveness and Adherence of Golimumab in Rheumatoid Arthritis

NCT04188249 | Unknown

• 1 other identifier: CNTO148ARA4012
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Percentage of low disease activity (DAS28-CRP) at week 12

  March 1, 2021

• Patient disease activity assessment (VAS) at week 12

  at week 12

• Patient Pain Global assessment (VAS) at week 12

  at week 12

• Function evaluation at week 12

  at week 12

• Medication possession rate (MPR) at week 12

  at week 12

Study Arms (1)

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

Drug: Golimumab

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.

RA patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• \- Contraindications for golimumab
• Prior exposure to TNFi/JAKi

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

golimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Xiaofeng Zeng, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nan Jiang, M.D.

CONTACT

+86 13683278877; jn_pumc@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: December 5, 2019
• Study Start: July 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: December 5, 2019

Record last verified: 2019-06

Locations

CN (1)