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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01081717 |
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Date of registration:
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04/03/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Golimumab Safety and Surveillance Program Using the Ingenix NHI Database
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Scientific title:
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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 |
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Date of first enrolment:
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April 14, 2009 |
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Target sample size:
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1064 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01081717 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Anja Geldhof, Eng, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Janssen Biotech, Inc. |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
99 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ankylosing Spondylitis
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Rheumatoid Arthritis
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Arthritis, Psoriatic
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Intervention(s)
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Drug: systemic non-biological treatments
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Biological: golimumab
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Biological: non-anti-TNF biologics
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Biological: anti-TNF biologics
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Other: general population
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Primary Outcome(s)
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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]
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Secondary ID(s)
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CNTO148ART4002
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CR016720
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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