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A Study of Juvenile Idiopathic Arthritis Patients Given Abatacept and the Number of Infections or Malignancies That Occur

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.
 
ClinicalTrials.gov Identifier: NCT03769558
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
This study will determine the incidences of infections and malignancies among JIA patients treated with abatacept

Condition or disease Intervention/treatment
Juvenile Idiopathic Arthritis Other: Non-Interventional

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Study Type : Observational
Actual Enrollment : 264 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Supplemental Data for the Juvenile Idiopathic Arthritis FDA Written Request
Actual Study Start Date : July 12, 2016
Actual Primary Completion Date : September 30, 2016
Actual Study Completion Date : September 30, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Group/Cohort Intervention/treatment
JIA patients prescribed abatacept Other: Non-Interventional
Non-Interventional




Primary Outcome Measures :
  1. Incidence of infections [ Time Frame: 110 months ]

Secondary Outcome Measures :
  1. Incidence of malignancies [ Time Frame: 110 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will include all patients with JIA who are treated with abatacept
Criteria

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

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): NCT03769558


Locations
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United States, New Jersey
Local Institution
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03769558     History of Changes
Other Study ID Numbers: IM101-643
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents