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A Large US Health Insurance Claims Database Will be Used to Estimate the Incidence of Serious Outcomes in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis Treated With Golimumab and Other Types of Biological and Systemic Non Biological Treatments


Phase 4
N/A
N/A
Open (Enrolling)
Both
Rheumatoid Arthritis, Arthritis, Psoriatic, Ankylosing Spondylitis

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Trial Information

A Large US Health Insurance Claims Database Will be Used to Estimate the Incidence of Serious Outcomes in Patients With Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis Treated With Golimumab and Other Types of Biological and Systemic Non Biological Treatments


The participants included in this study will be drawn from the Ingenix Normative Health
Informatics Database, a proprietary research database containing claims and enrollment data
dating back to 1993 for members of a large, geographically diverse US health plan. This
study will include cohorts of participants who have claims consistent with a diagnosis of
rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis and who initiate
golimumab, anti-TNF biologics, non-anti-TNF biologics, or systemic non-biological
treatments. Participants will be identified by claims bearing codes for dispensed drugs,
procedures or diagnoses and followed after the launch of golimumab for up to 8 years. A
sample of enrolled health plan members without claims evidence of diagnosis or treatment of
Rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis will also be selected.
The claims database will be used to estimate the incidence of the primary outcomes of
serious infections, tuberculosis (TB) and non-TB mycobacterial infections, malignancies such
as lymphoma, and other selected outcomes. No study agents will be administered in this
study. All participants will receive standard-of-care treatment as prescribed by their
physician


Inclusion Criteria:



- Complete medical coverage and pharmacy benefits

- Six months of continuous enrollment prior to the date of cohort entry

Exclusion Criteria:

- Participants will be excluded if they do not have information on age, gender or
enrollment

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Estimate incidence of serious infections, malignancies, and other selected outcomes in patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis initiating golimumab and other biological and systemic non-biological treatment

Outcome Time Frame:

The study will be approximately 8 years in duration

Safety Issue:

Yes

Principal Investigator

Anja Geldhof, Eng, Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Biotech, Inc.

Authority:

United States: Institutional Review Board

Study ID:

CR016720

NCT ID:

NCT01081717

Start Date:

April 2009

Completion Date:

September 2017

Related Keywords:

  • Rheumatoid Arthritis
  • Arthritis, Psoriatic
  • Ankylosing Spondylitis
  • Rheumatoid arthritis
  • psoriatic arthritis
  • ankylosing spondylitis
  • golimumab
  • anti-TNF biologics
  • non-anti-TNF biologics
  • non-biological treatments
  • Arthritis
  • Arthritis, Psoriatic
  • Arthritis, Rheumatoid
  • Spondylitis
  • Spondylitis, Ankylosing

Name

Location

OptumInsight Life SciencesWaltham, Massachusetts  02451