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)

NCT02784808 | Completed

• 1 other identifier: GA29396
• Study Type: observational
• Target: 4,557
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with pulmonary arterial hypertension

  up to the end of the study (up to overall period of 12 years)

Secondary Outcomes (5)

• 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)

Study Arms (2)

Biologic DMARDs

Participants who received biologic DMARDs as per standard of care were included in this arm.

Drug: Biological DMARDs

Non-biological DMARDs

Participants who received non-biologic DMARDs as per standard of care were included in this arm.

Drug: Non-Biologic DMARDs

Interventions

Biological DMARDs DRUG

Participants will receive biologic DMARDs as per standard of CARE. The choice of specific biologic DMARD will be at the descretion of treating physician.

Biologic DMARDs

Non-Biologic DMARDs DRUG

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.

Non-biological DMARDs

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2016
• First Posted: May 27, 2016
• Study Start: January 1, 2000
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 8, 2016

Record last verified: 2016-06