Registry for Analysis of Compliance in Colombian Participants With Rheumatoid Arthritis Exposed to Golimumab

NCT ID: NCT02414984

Last Updated: 2017-02-13

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-11-30

Brief Summary

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.

Detailed 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.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Golimumab

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.

Golimumab

Intervention Type: BIOLOGICAL

This is an observational study. Participants with rheumatoid arthritis in Colombia will be observed for 24 months.

Interventions

Golimumab

This is an observational study. Participants with rheumatoid arthritis in Colombia will be observed for 24 months.

Intervention Type: BIOLOGICAL

Other Intervention Names

CNTO148

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag, S.A. Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag, S.A.

Locations

Barranquilla, , Colombia

Bogotá, , Colombia

Bucaramanga, , Colombia

Cali, , Colombia

Medellín, , Colombia

Countries

Colombia

Other Identifiers

CNTO148ARA4004

Identifier Type: OTHER

Identifier Source: secondary_id

CR105492

Identifier Type: -

Identifier Source: org_study_id