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

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ClinicalTrials.gov Identifier: NCT02414984
Recruitment Status : Terminated (Insufficient enrollment (Terminated due to lack of patient recruitment))
First Posted : April 13, 2015
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag, S.A.

Tracking Information
First Submitted Date April 8, 2015
First Posted Date April 13, 2015
Last Update Posted Date February 13, 2017
Study Start Date March 2015
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 8, 2015)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02414984 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 8, 2015)
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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 ]
    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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Registry for Analysis of Compliance in Colombian Participants With Rheumatoid Arthritis Exposed to Golimumab
Official Title Registry of Patients With Rheumatoid Arthritis Exposed to Golimumab (Go-Compl-Ar): Review and Analysis of Compliance in Colombia
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 24 Months
Biospecimen Not Provided
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.
Condition Rheumatoid Arthritis
Intervention Biological: Golimumab
This is an observational study. Participants with rheumatoid arthritis in Colombia will be observed for 24 months.
Other Name: CNTO148
Study Groups/Cohorts 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.
Intervention: Biological: Golimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: February 10, 2017)
37
Original Estimated Enrollment
 (submitted: April 8, 2015)
113
Actual Study Completion Date November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Colombia
Removed Location Countries  
 
Administrative Information
NCT Number NCT02414984
Other Study ID Numbers CR105492
CNTO148ARA4004 ( Other Identifier: Janssen-Cilag, S.A. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Janssen-Cilag, S.A.
Study Sponsor Janssen-Cilag, S.A.
Collaborators Not Provided
Investigators
Study Director: Janssen-Cilag, S.A. Clinical Trial Janssen-Cilag, S.A.
PRS Account Janssen-Cilag, S.A.
Verification Date February 2017