Overview

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)

Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Antirheumatic Agents
Criteria
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