Clinical trial NCT02784808: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-05-27
Enrollment: 4557
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: JIA participants treated with biologic and non-biologic DMARDs from the Thomson Reuters MarketScan® Commercial Claims and Medicare Supplemental Databases

Brief 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.


Eligibility 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

Primary outcomes:
measure: Percentage of participants with pulmonary arterial hypertension
timeFrame: up to the end of the study (up to overall period of 12 years)
Secondary outcomes:
measure: Percentage of participants with interstitial lung disease
timeFrame: up to the end of study (up to overall period of 12 years)
measure: Percentage of participants with alveolar proteinsis
timeFrame: up to the end of study (approximately 2.2 years)
measure: Percentage of participants with lipoid pneumonia
timeFrame: up to the end of study (up to overall period of 12 years)
measure: Percentage of participants with pulmonary hypertension
timeFrame: up to the end of study (up to overall period of 12 years)
measure: Percentage of participants with overall composite pulmonary complications
timeFrame: up to the end of study (up to overall period of 12 years)
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: