Registry for Analysis of Compliance in Colombian Participants With Rheumatoid Arthritis Exposed to Golimumab (Go-Compl-Ar)

Janssen (J&J Innovative Medicine)

Status: Terminated

Conditions: Rheumatoid Arthritis

Treatments: Biological: Golimumab

Study type: Observational

Funder types: Industry

Identifiers

NCT02414984

CNTO148ARA4004 (Other Identifier)

CR105492

Details and patient eligibility

About

The purpose of this study is to describe adherence to golimumab in Colombian participants with rheumatoid arthritis (RA) experiencing adequate treatment response, in a real-world clinical settings.

Full description

This is a multi-center (when more than one hospital or medical school team work on a medical research study), non-interventional, prospective cohort study that will enroll participants with RA in Colombia, for whom the treating physician has decided to treat with golimumab prior to enrolment. All participants will be observed for adherence to golimumab treatment for 24 months from study start (Week 0), and recommended follow up assessments will be every 3 months. Any changes including addition of new medications or dose modifications of existing medications will be entirely according to the treating physician's judgment. Participants' safety will be monitored throughout the study.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with moderate to severe RA for whom the physician had decided to treat with golimumab according to the local product label, with the first dose being administered between 12 and 26 weeks prior to study enrollment
• Participants who have achieved an adequate therapeutic response to regular doses of golimumab, within 12 to 26 weeks of treatment
• Participants should be evaluated for tuberculosis (TB) exposure/risk factors or managed for active and latent TB (per local requirements and according to the local product label)
• Participants who have been evaluated for active/latent hepatitis B virus (HBV) and hepatitis C virus (HCV)
• Participants for whom, since golimumab initiation, a complete medical record is available

Exclusion criteria

• Participants who have received and terminated golimumab treatment in the past
• Participants that have been treated with golimumab for more than 26 weeks prior to enrolment in the study
• Participants with use of any other investigational agent less than or equal to 30 days before starting treatment with golimumab
• Participants with suspected latent TB, having not received prophylactic treatment of at least 4 weeks
• Participants with suspected or active TB
• Participants with active/latent HBV or HCV

Trial design

37 participants in 1 patient group

Golimumab

Description:

Participants with rheumatoid arthritis in Colombia, for whom the treating physician has decided to treat with golimumab prior to enrolment. All participants will be observed for 24 months. Any changes including addition of new medications or dose modifications of existing medications will be entirely according to the treating physician's judgment.

Treatment:

Biological: Golimumab