- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03769558
A Study of Juvenile Idiopathic Arthritis Patients Given Abatacept and the Number of Infections or Malignancies That Occur
March 19, 2020 updated by: Bristol-Myers Squibb
Supplemental Data for the Juvenile Idiopathic Arthritis FDA Written Request
This study will determine the incidences of infections and malignancies among JIA patients treated with abatacept
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
264
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Princeton, New Jersey, United States, 08540
- Local Institution
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The study population will include all patients with JIA who are treated with abatacept
Description
Inclusion Criteria:
- Two diagnoses of JIA (ICD-9 code 714.3x) within 90 days
- Age less than 18 years at the time of second of the two diagnoses
- Index date is the date of initiating treatment with abatacept
Exclusion Criteria:
- Greater than or equal to 18 years of age
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
JIA patients prescribed abatacept
|
Non-Interventional
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of infections
Time Frame: 110 months
|
110 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of malignancies
Time Frame: 110 months
|
110 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 12, 2016
Primary Completion (Actual)
September 30, 2016
Study Completion (Actual)
September 30, 2016
Study Registration Dates
First Submitted
December 6, 2018
First Submitted That Met QC Criteria
December 6, 2018
First Posted (Actual)
December 7, 2018
Study Record Updates
Last Update Posted (Actual)
March 20, 2020
Last Update Submitted That Met QC Criteria
March 19, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IM101-643
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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