Golimumab Safety and Surveillance Program Using the Ingenix NHI Database

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT01081717
First received: March 4, 2010
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
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
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Janssen Biotech, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: April 2009
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081717

Locations
United States, Massachusetts
OptumInsight Life Sciences
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Janssen Biotech, Inc.
Investigators
Study Director: Anja Geldhof, Eng, Ph.D. Janssen Biotech, Inc.
  More Information

No publications provided

Responsible Party: Janssen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT01081717     History of Changes
Other Study ID Numbers: CR016720, CNTO148ART4002
Study First Received: March 4, 2010
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

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, Psoriatic
Spondylitis
Spondylitis, Ankylosing
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Bone Diseases, Infectious
Infection
Ankylosis
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 16, 2014