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Golimumab Safety and Surveillance Program Using the Ingenix NHI Database

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ClinicalTrials.gov Identifier: NCT01081717
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Biotech, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Arthritis, Psoriatic Ankylosing Spondylitis Drug: systemic non-biological treatments Biological: anti-TNF biologics Biological: golimumab Biological: non-anti-TNF biologics Other: general population

Detailed Description:
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

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : April 14, 2009
Actual Primary Completion Date : May 31, 2015
Actual Study Completion Date : May 31, 2015


Group/Cohort Intervention/treatment
001
golimumab as prescribed
Biological: golimumab
as prescribed

002
anti-TNF biologics as prescribed
Biological: anti-TNF biologics
as prescribed

003
non-anti-TNF biologics as prescribed
Biological: non-anti-TNF biologics
as prescribed

004
systemic non-biological treatments as prescribed
Drug: systemic non-biological treatments
as prescribed

005
general population non-treated cohort
Other: general population
non-treated cohort




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081717


Sponsors and Collaborators
Janssen Biotech, Inc.
Investigators
Study Director: Anja Geldhof, Eng, Ph.D. Janssen Biotech, Inc.

Responsible Party: Janssen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT01081717     History of Changes
Other Study ID Numbers: CR016720
CNTO148ART4002 ( Other Identifier: Janssen Biotech, Inc. )
First Posted: March 5, 2010    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Biotech, Inc.:
Rheumatoid arthritis
psoriatic arthritis
ankylosing spondylitis
golimumab
anti-TNF biologics
non-anti-TNF biologics
non-biological treatments

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Spondylitis
Spondylitis, Ankylosing
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs