Clinical trial NCT02414984: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Golimumab
Observational
Compliance
Lead sponsor: Janssen-Cilag, S.A.
Sponsor class: INDUSTRY
First posted: 2015-04-13
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Treatment Adherence Measured by Continuous Measures of Medication Gaps (CMG)
timeFrame: 24 months
Secondary outcomes:
measure: Frequency of Treatment Suspension
timeFrame: 24 months
measure: Number of Treatment Termination
timeFrame: 24 months
measure: Change From Baseline in 28-Joint Disease Activity Score (DAS-28) at Month 6, 12, 18, and 24 or Early Termination
timeFrame: Baseline, Month 6, 12, 18, and 24 or Early Termination
measure: Change From Baseline in Patient's Global Assessment (PtGA) at Month 6, 12, 18, and 24 or Early Termination
timeFrame: Baseline, Month 6, 12, 18, and 24 or Early Termination
measure: Change From Baseline in Physician Global Assessment of Disease Activity (MDGA) at Month 6, 12, 18, and 24 or Early Termination
timeFrame: Baseline, Month 6, 12, 18, and 24 or Early Termination
measure: Change From Baseline in Work Related Productivity at Month 6, 12, 18, and 24 or Early Termination
timeFrame: Baseline, Month 6, 12, 18, and 24 or Early Termination
measure: Change From Baseline in Quality of Life at Month 12 and 24 or Early Termination
timeFrame: Baseline, Month 12 and 24 or Early Termination
measure: Change From Baseline in Functional Status at Month 6, 12, 18, and 24 or Early Termination
timeFrame: Baseline, Month 6, 12, 18, and 24 or Early Termination
measure: Change from Baseline in Utilization of Health Care Resources at Month 3, 6, 9, 12, 15, 18, 21, and 24 or Early Termination
timeFrame: Baseline, Month 3, 6, 9, 12, 15, 18, 21, and 24 or Early Termination
measure: Number of Participants with Adverse Events (AEs) Leading to Treatment Discontinuation
timeFrame: 24 months
measure: Number of Participants with Serious adverse Events (SAE)
timeFrame: 24 months
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
city: Bogota
country: Colombia
city: Bogotá
country: Colombia
city: Bucaramanga
country: Colombia
city: Cali
country: Colombia
city: Medellin
country: Colombia
city: Medellín
country: Colombia
Study officials:
affiliation: Janssen-Cilag, S.A.
name: Janssen-Cilag, S.A. Clinical Trial
role: STUDY_DIRECTOR
References: