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.
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
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.
- Conditions
- Rheumatoid Arthritis
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Golimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation
Measured: 24 months
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.
- First posted13 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Insufficient enrollment (Terminated due to lack of patient recruitment)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag, S.A. Clinical Trial, Study director, Janssen-Cilag, S.A.
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of Patients With Rheumatoid Arthritis Exposed to Golimumab (Go-Compl-Ar): Review and Analysis of Compliance in Colombia
- ClinicalTrials.gov ID
- NCT02414984
- Acronym / sponsor ID
- Go-Compl-Ar / CR105492
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Golimumab, Observational, Compliance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment (Terminated due to lack of patient recruitment)
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Janssen-Cilag, S.A.Industry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 13 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Golimumab | – | Biological: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GolimumabAlso: CNTO148This is an observational study. Participants with rheumatoid arthritis in Colombia will be observed for 24 months. | Biological | Golimumab |
Primary outcome
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.
11 secondary outcomes
Frequency of Treatment Suspension
Time frame: 24 months
Number of Treatment Termination
Time frame: 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
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
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
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
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
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
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
Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation
Time frame: 24 months
Number of Participants with Serious adverse Events (SAE)
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Insufficient enrollment (Terminated due to lack of patient recruitment)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag, S.A. Clinical Trial study director
Janssen-Cilag, S.A.
5 sites in 1 country: see every site and its status.
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.