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OpenTrials
Completed

NCT Number: 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)

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.

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Key information

Conditions

Juvenile Idiopathic Arthritis Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Percentage of participants with pulmonary arterial hypertension

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

Secondary outcomes

  1. Percentage of participants with interstitial lung disease

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

  2. Percentage of participants with alveolar proteinsis

    Time frame: up to the end of study (approximately 2.2 years)

  3. Percentage of participants with lipoid pneumonia

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

  4. Percentage of participants with pulmonary hypertension

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

  5. Percentage of participants with overall composite pulmonary complications

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2000
Primary completion
2012
Study completion
2012
First posted
May 27, 2016
Registry last updated
Jun 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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