Study Stopped
Insufficient enrollment (Terminated due to lack of patient recruitment)
Registry for Analysis of Compliance in Colombian Participants With Rheumatoid Arthritis Exposed to Golimumab
Go-Compl-Ar
Registry of Patients With Rheumatoid Arthritis Exposed to Golimumab (Go-Compl-Ar): Review and Analysis of Compliance in Colombia
2 other identifiers
observational
37
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2015
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 8, 2015
CompletedFirst Posted
Study publicly available on registry
April 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedFebruary 13, 2017
February 1, 2017
1.7 years
April 8, 2015
February 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment Adherence Measured by Continuous Measures of Medication Gaps (CMG)
Adherence rates to golimumab will be measured by the Continuous Measures of Medication Gaps (CMG). CMG provides an approximate percentage of time in which a participant is without medication available for use. Number of days of delay between consecutive golimumab injections will be observed throughout the study.
24 months
Secondary Outcomes (11)
Frequency of Treatment Suspension
24 months
Number of Treatment Termination
24 months
Change From Baseline in 28-Joint Disease Activity Score (DAS-28) at Month 6, 12, 18, and 24 or Early Termination
Baseline, Month 6, 12, 18, and 24 or Early Termination
Change From Baseline in Patient's Global Assessment (PtGA) at Month 6, 12, 18, and 24 or Early Termination
Baseline, Month 6, 12, 18, and 24 or Early Termination
Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Month 6, 12, 18, and 24 or Early Termination
Baseline, Month 6, 12, 18, and 24 or Early Termination
- +6 more secondary outcomes
Study Arms (1)
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.
Interventions
This is an observational study. Participants with rheumatoid arthritis in Colombia will be observed for 24 months.
Eligibility Criteria
The study population will consist of Colombian rheumatoid arthritis participants, who have been prescribed golimumab by their treating physician prior to, and independently of, study enrollment.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Barranquilla, Colombia
Unknown Facility
Bogotá, Colombia
Unknown Facility
Bucaramanga, Colombia
Unknown Facility
Cali, Colombia
Unknown Facility
Medellín, Colombia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag, S.A. Clinical Trial
Janssen-Cilag, S.A.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2015
First Posted
April 13, 2015
Study Start
March 1, 2015
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
February 13, 2017
Record last verified: 2017-02
Data Sharing
- IPD Sharing
- Will not share