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NCT03769558 Clinical Trial

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

Juvenile Idiopathic Arthritis Clinical Trial

Official title:
Supplemental Data for the Juvenile Idiopathic Arthritis FDA Written Request

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03769558
Other study ID # IM101-643
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 12, 2016
Est. completion date September 30, 2016

Study information
Verified date March 2020
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 264
Est. completion date September 30, 2016
Est. primary completion date September 30, 2016
Accepts healthy volunteers No
Gender All
Age group 12 Months and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations
Country Name City State
United States Local Institution Princeton New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of infections 110 months
Secondary Incidence of malignancies 110 months
See also
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Completed NCT01455701 - A Study to Evaluate Pharmacokinetics and Safety of Tocilizumab (RoActemra/Actemra) in Participants Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA) Phase 1
Completed NCT05031104 - Low-energy Laser Applications in Patients With Juvenile Idiopathic Arthritis N/A
Not yet recruiting NCT01436019 - Study of Antibodies to Anti-TNF Agents in Juvenile Idiopathic Arthritis N/A
Recruiting NCT05609630 - Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis. Phase 3
Recruiting NCT05696340 - Access to Pediatric Rheumatology Centers for JIA Patients: Factors Associated With Time to Access Pediatric Rheumatology Centers
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Completed NCT05436301 - Turkish Validity and Reliability of Pain Catastrophizing Scale-Child (PCS-C)

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