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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03769558
• Collaborator: (none)
• Enrollment: 264
• Location: 1
• Actual Duration (Months): 2.6
• Patients Per Site Per Month: 100.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Juvenile Idiopathic Arthritis	Other: Non-Interventional

Study Design

• 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: Jul 12, 2016
• Actual Primary Completion Date: Sep 30, 2016
• Actual Study Completion Date: Sep 30, 2016

Arms and Interventions

Arm	Intervention/Treatment
JIA patients prescribed abatacept	Other: Non-Interventional; Non-Interventional

Outcome Measures

Primary Outcome Measures

1. Incidence of infections [110 months]

Secondary Outcome Measures

1. Incidence of malignancies [110 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Months and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Princeton	New Jersey	United States	08540

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03769558
• Other Study ID Numbers: IM101-643
• First Posted: Dec 7, 2018
• Last Update Posted: Mar 20, 2020
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arthritis; Arthritis, Juvenile

Study Results

No Results Posted as of Mar 20, 2020