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)

Completed

• Conditions: Juvenile Idiopathic Arthritis
• Interventions: Drug: Non-Biologic DMARDs; Drug: Biological DMARDs

• Registration Number: NCT02784808
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-27
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-06
• Last Update Posted: 2016-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4557

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Percentage of participants with pulmonary arterial hypertension	up to the end of the study (up to overall period of 12 years)

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with interstitial lung disease	up to the end of study (up to overall period of 12 years)
Percentage of participants with alveolar proteinsis	up to the end of study (approximately 2.2 years)
Percentage of participants with lipoid pneumonia	up to the end of study (up to overall period of 12 years)
Percentage of participants with pulmonary hypertension	up to the end of study (up to overall period of 12 years)
Percentage of participants with overall composite pulmonary complications	up to the end of study (up to overall period of 12 years)