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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	20 June 2016
Main ID:	NCT02784808
Date of registration:	25/05/2016
Prospective Registration:	No
Primary sponsor:	Hoffmann-La Roche
Public title:	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)
Scientific title:
Date of first enrolment:	January 2000
Target sample size:	4557
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02784808
Study type:	Observational
Study design:	Observational Model: Case Control, Time Perspective: Cross-Sectional
Phase:	N/A

Countries of recruitment

Contacts

Name:	Clinical Trials
Address:
Telephone:
Email:
Affiliation:	Hoffmann-La Roche

Key inclusion & exclusion 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

Age minimum: N/A
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Juvenile Idiopathic Arthritis

Intervention(s)

Drug: Biological DMARDs

Drug: Non-Biologic DMARDs

Primary Outcome(s)

Percentage of participants with pulmonary arterial hypertension [Time Frame: up to the end of the study (up to overall period of 12 years)]

Secondary Outcome(s)

Percentage of participants with alveolar proteinsis [Time Frame: up to the end of study (approximately 2.2 years)]

Percentage of participants with lipoid pneumonia [Time Frame: up to the end of study (up to overall period of 12 years)]

Percentage of participants with pulmonary hypertension [Time Frame: up to the end of study (up to overall period of 12 years)]

Percentage of participants with interstitial lung disease [Time Frame: up to the end of study (up to overall period of 12 years)]

Percentage of participants with overall composite pulmonary complications [Time Frame: up to the end of study (up to overall period of 12 years)]

Secondary ID(s)

GA29396

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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