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Golimumab Safety and Surveillance Program Using the Ingenix NHI Database

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01081717
First Posted: March 5, 2010
Last Update Posted: November 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen Biotech, Inc.
March 4, 2010
March 5, 2010
November 28, 2017
April 14, 2009
June 1, 2018   (Final data collection date for primary 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 [ Time Frame: The study will be approximately 8 years in duration ]
Same as current
Complete list of historical versions of study NCT01081717 on ClinicalTrials.gov Archive Site
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Golimumab Safety and Surveillance Program Using the Ingenix NHI Database
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 observational study will be drawn from a research database containing claims and enrollment data for members of a large, geographically diverse US health plan.The objective of this study is to estimate the rate of serious infections, tuberculosis, malignancies, and other outcomes in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis patients treated with golimumab, anti-tumor necrosis factor (TNF) biologics, non-anti-TNF biologics, or 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
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
This study will include cohorts of patients who have claims consistent with a diagnosis of rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis who initiate golimumab, anti-TNF biologics, non-anti-TNF biologics, or systemic non-biological treatments, within the Ingenix Normative Health Informatics Database.
  • Rheumatoid Arthritis
  • Arthritis, Psoriatic
  • Ankylosing Spondylitis
  • Drug: systemic non-biological treatments
    as prescribed
  • Biological: anti-TNF biologics
    as prescribed
  • Biological: golimumab
    as prescribed
  • Biological: non-anti-TNF biologics
    as prescribed
  • Other: general population
    non-treated cohort
  • 001
    golimumab as prescribed
    Intervention: Biological: golimumab
  • 002
    anti-TNF biologics as prescribed
    Intervention: Biological: anti-TNF biologics
  • 003
    non-anti-TNF biologics as prescribed
    Intervention: Biological: non-anti-TNF biologics
  • 004
    systemic non-biological treatments as prescribed
    Intervention: Drug: systemic non-biological treatments
  • 005
    general population non-treated cohort
    Intervention: Other: general population
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
June 1, 2018
June 1, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 99 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01081717
CR016720
CNTO148ART4002 ( Other Identifier: Janssen Biotech, Inc. )
No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Janssen Biotech, Inc.
Janssen Biotech, Inc.
Not Provided
Study Director: Anja Geldhof, Eng, Ph.D. Janssen Biotech, Inc.
Janssen Biotech, Inc.
November 2017