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Rheumatoid ArthritisGo-Compl-ArNCT02414984

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

An observational study of Rheumatoid Arthritis, run by Janssen-Cilag, S.A. at 5 sites in Colombia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Golimumab
How many people
37 participants
Where
5 sitesColombia
Study dates
Mar 2015to Nov 2016
How long will I take part?
24 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

5 sites in 1 country.

5 sites in 1 country

Colombia5 sites
  • Study site

    Barranquilla

  • Study site

    Bogotá

  • Study site

    Bucaramanga

  • Study site

    Cali

  • Study site

    Medellín

Other trials in Colombia

About this study

Official title: 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.

Read the 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.

Being tested
Golimumab
Keywords
Rheumatoid Arthritis, Golimumab, Observational, Compliance
Medical subject headings
Arthritis, Rheumatoid, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GolimumabBiological

    Also called CNTO148

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

Study groups in NCT02414984
Study groupRoleWhat they receive
GolimumabParticipants 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.
Receives: Biological: Golimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

Secondary outcomes (11)
  1. Frequency of Treatment Suspension

    Treatment suspension is defined as a treatment gap of at least 2 cycles of golimumab, with subsequent restart, as assessed by CMG.

    Measured: 24 months

  2. Number of Treatment Termination

    Treatment termination is defined as a treatment gap of at least 2 cycles of golimumab, with no treatment restart as assessed by CMG.

    Measured: 24 months

  3. Change From Baseline in 28-Joint Disease Activity Score (DAS-28) at 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).

    Measured: Baseline, Month 6, 12, 18, and 24 or Early Termination

  4. Change From Baseline in Patient's Global Assessment (PtGA) at 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.

    Measured: Baseline, Month 6, 12, 18, and 24 or Early Termination

  5. Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at 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.

    Measured: Baseline, Month 6, 12, 18, and 24 or Early Termination

  6. Change From Baseline in Work Related Productivity at 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.

    Measured: Baseline, Month 6, 12, 18, and 24 or Early Termination

  7. Change From Baseline in Quality of Life at 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.

    Measured: Baseline, Month 12 and 24 or Early Termination

  8. Change From Baseline in Functional Status at 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.

    Measured: Baseline, Month 6, 12, 18, and 24 or Early Termination

  9. Change from Baseline in Utilization of Health Care Resources at 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).

    Measured: Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24 or Early Termination

  10. Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation

    Measured: 24 months

  11. Number of Participants with Serious adverse Events (SAE)

    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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionNov 2016
  4. Study completionNov 2016

Why it stopped: Insufficient enrollment (Terminated due to lack of patient recruitment)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
37 participants (actual)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02414984
Sponsor's protocol ID
CR105492
Other IDs
CNTO148ARA4004
Acronym
Go-Compl-Ar
Status last verified
Feb 2017
First submitted
8 Apr 2015
Last updated
13 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Janssen-Cilag, S.A. at 5 sites in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Insufficient enrollment (Terminated due to lack of patient recruitment)). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Adherence Measured by Continuous Measures of Medication Gaps (CMG) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017.

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