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Retrospective Analysis of Pulmonary Arterial Hypertension (PAH) and Related Complications in Juvenile Idiopathic Arthritis (JIA) Participants Treated With Biologic and Non-biologic Disease-modifying Anti-rheumatic Drugs (DMARDs)

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Roche

Status

Completed

Conditions

Juvenile Idiopathic Arthritis

Treatments

Drug: Non-Biologic DMARDs
Drug: Biological DMARDs

Study type

Observational

Funder types

Industry

Identifiers

NCT02784808
GA29396

Details and patient eligibility

About

This study is designed to analyze the frequency and incidence rate of pulmonary complications in JIA participants who received biological DMARDs and non-biologic DMARDs. The participants having evidence of of a prescription or administration of one of the biologic or non-biologic DMARDs will be included in five different treatment groups. Data from the Thomson Reuters MarketScan® Commercial Claims and Medicare Supplemental Databases will be used to estimate the incidence rate of pulmonary complications.

Enrollment

4,557 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants with less than (<) 18 years of age at index
  • Continuously enrolled for greater than (>) 6 months prior to index (baseline period)
  • One diagnosis of JIA (714.3) on a non-diagnostic claim either during the baseline period (the complete participant record prior to the episode index will be defined as the episode baseline period) or within the first 30 days following the index date
  • Had both medical and pharmacy benefit plus complete data availability during both baseline and follow-up periods

Exclusion criteria

  • For biologic DMARD cohorts, prior use of any qualifying biologic belonging to the biologic DMARD of interest (using all available claims history)
  • For non-biologic DMARD cohort, prior use of any non-biologic DMARD or biologic DMARD
  • Any record of rituximab use in complete participant record
  • A prior safety event during the baseline period

Trial design

4,557 participants in 2 patient groups

Biologic DMARDs
Description:
Participants who received biologic DMARDs as per standard of care were included in this arm.
Treatment:
Drug: Biological DMARDs
Non-biological DMARDs
Description:
Participants who received non-biologic DMARDs as per standard of care were included in this arm.
Treatment:
Drug: Non-Biologic DMARDs

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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