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)

Juvenile Idiopathic Arthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784808
• Other study ID #: GA29396
• Status: Completed
• Phase: N/A
• First received: May 25, 2016
• Last updated: June 6, 2016
• Start date: January 2000
• Est. completion date: December 2012

Study information

• Verified date: June 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Country: Not Applicable
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4557
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

Drug:
• Biological DMARDs
Participants will receive biologic DMARDs as per standard of CARE. The choice of specific biologic DMARD will be at the descretion of treating physician.
• Non-Biologic DMARDs
Participants will receive non-biologic DMARDs as per standard of care. The choice of specific non-biologic DMARD will be at the descretion of treating physician.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with pulmonary arterial hypertension		up to the end of the study (up to overall period of 12 years)	No
Secondary	Percentage of participants with interstitial lung disease		up to the end of study (up to overall period of 12 years)	No
Secondary	Percentage of participants with alveolar proteinsis		up to the end of study (approximately 2.2 years)	No
Secondary	Percentage of participants with lipoid pneumonia		up to the end of study (up to overall period of 12 years)	No
Secondary	Percentage of participants with pulmonary hypertension		up to the end of study (up to overall period of 12 years)	No
Secondary	Percentage of participants with overall composite pulmonary complications		up to the end of study (up to overall period of 12 years)	No