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

February 10, 2017 updated by: Janssen-Cilag, S.A.

Registry of Patients With Rheumatoid Arthritis Exposed to Golimumab (Go-Compl-Ar): Review and Analysis of Compliance in Colombia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Barranquilla, Colombia
      • Bogota, Colombia
      • Bogotá, Colombia
      • Bucaramanga, Colombia
      • Cali, Colombia
      • Medellin, Colombia
      • Medellín, Colombia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Biological: Golimumab
This is an observational study. Participants with rheumatoid arthritis in Colombia will be observed for 24 months.
Other Names:
  • CNTO148

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Treatment Adherence Measured by Continuous Measures of Medication Gaps (CMG)
Time Frame: 24 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of Treatment Suspension
Time Frame: 24 months
Treatment suspension is defined as a treatment gap of at least 2 cycles of golimumab, with subsequent restart, as assessed by CMG.
24 months
Number of Treatment Termination
Time Frame: 24 months
Treatment termination is defined as a treatment gap of at least 2 cycles of golimumab, with no treatment restart as assessed by CMG.
24 months
Change From Baseline in 28-Joint Disease Activity Score (DAS-28) at Month 6, 12, 18, and 24 or Early Termination
Time Frame: Baseline, Month 6, 12, 18, and 24 or Early Termination
DAS28 is calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) or the C-reactive protein (CRP) and patient's global assessment (PtGA) of disease activity (participant rate arthritis activity using visual analog scale [VAS] ranging from 0 to 100; higher scores indicated greater affectation due to disease activity).
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
Time Frame: Baseline, Month 6, 12, 18, and 24 or Early Termination
Participant will rate arthritis activity using Visual Analog Scale (VAS) ranging from 0 to 100; higher scores indicated greater affectation due to disease activity.
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
Time Frame: Baseline, Month 6, 12, 18, and 24 or Early Termination
Physician will rate arthritis activity using Visual Analog Scale (VAS) ranging from 0 to 100; higher scores indicated greater affectation due to disease activity.
Baseline, Month 6, 12, 18, and 24 or Early Termination
Change From Baseline in Work Related Productivity at Month 6, 12, 18, and 24 or Early Termination
Time Frame: Baseline, Month 6, 12, 18, and 24 or Early Termination
Work related productivity (absenteeism, presenteeism, and impairment in daily activities) will be assessed using Work Productivity and Activity Impairment Questionnaire: Rheumatoid Arthritis (WPAI-RA), which consisted of 6 items: 1) Current employment status; 2) Number of hours missed due to a health problem; 3) Number of hours missed due to other reasons; 4) Hours actually worked; 5) Degree to which health affected productivity while working; 6) Degree to which health affected regular (non-work) activities.
Baseline, Month 6, 12, 18, and 24 or Early Termination
Change From Baseline in Quality of Life at Month 12 and 24 or Early Termination
Time Frame: Baseline, Month 12 and 24 or Early Termination
Quality of life will be assessed by 36-Item Short-Form Health Survey (SF-36). SF-36 is a generic quality of life questionnaire that assesses 8 health concepts: 1) Limitations in physical activities because of health problems; 2) Limitations in social activities because of physical or emotional problems; 3) Limitations in usual role activities because of physical health problems; 4) Bodily pain; 5) General mental health (psychological distress and well-being); 6) Limitations in usual role activities because of emotional problems; 7) Vitality (energy and fatigue); 8) General health perceptions.
Baseline, Month 12 and 24 or Early Termination
Change From Baseline in Functional Status at Month 6, 12, 18, and 24 or Early Termination
Time Frame: Baseline, Month 6, 12, 18, and 24 or Early Termination
Functional status will be assessed by Health Assessment Questionnaire-Disability Index (HAQ-DI). HAQ-DI is a self-administered questionnaire measuring the participant's functional ability. It consists of 20 items converging to 8 scales measuring daily living activities: dress/groom; arise; eat; walk; hygiene; reach; grip; and common daily activities over past week. The participant rate each activity as 0 = without any difficulty, 1 = some difficulty, 2 = much difficulty and 3 = unable. The final score ranges from 0 to 3 with higher scores indicating more disability.
Baseline, Month 6, 12, 18, and 24 or Early Termination
Change from Baseline in Utilization of Health Care Resources at Month 3, 6, 9, 12, 15, 18, 21, and 24 or Early Termination
Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24 or Early Termination
Utilization of Health Care Resources will be measured by the Consumption of Health Care Resources Questionnaire, which includes 8 questions related to the participant's use of health care resources related to RA: 1) Extra or unscheduled visits to the study doctor office/clinic, 2) Visits to another physician/healthcare professional (like nurse, therapist, physiotherapist), 3) Visits to hospital emergency room/ total duration of stay (hours), 4) Use of an ambulance service, 5) Admitted to a hospital/ total duration of stay (hours), 6) Visit to a specialist, 7) Complementary alternative therapy visits, 8) Out of pocket expenses related to RA (for example over-the-counter medication, payments for health care professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, transportation costs, differences in cost of prescription medication not covered by insurance).
Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24 or Early Termination
Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation
Time Frame: 24 months
24 months
Number of Participants with Serious adverse Events (SAE)
Time Frame: 24 months
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen-Cilag, S.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen-Cilag, S.A. Clinical Trial, Janssen-Cilag, S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR105492
  • CNTO148ARA4004 (Other Identifier: Janssen-Cilag, S.A.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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