Juvenile Idiopathic ArthritisNCT02784808
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)
An observational study of Juvenile Idiopathic Arthritis, run by Hoffmann-La Roche.
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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Biological DMARDs and Non-Biologic DMARDs
- How many people
- 4,557 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: JIA participants treated with biologic and non-biologic DMARDs from the Thomson Reuters MarketScan® Commercial Claims and Medicare Supplemental Databases
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
- Being tested
- Biological DMARDs, Non-Biologic DMARDs
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological DMARDsDrug
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 DMARDsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Biologic DMARDs | Participants who received biologic DMARDs as per standard of care were included in this arm. Receives: Drug: Biological DMARDs | |
| Non-biological DMARDs | Participants who received non-biologic DMARDs as per standard of care were included in this arm. Receives: Drug: Non-Biologic DMARDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with pulmonary arterial hypertension
Measured: up to the end of the study (up to overall period of 12 years)
Secondary outcomes (5)
Percentage of participants with interstitial lung disease
Measured: up to the end of study (up to overall period of 12 years)
Percentage of participants with alveolar proteinsis
Measured: up to the end of study (approximately 2.2 years)
Percentage of participants with lipoid pneumonia
Measured: up to the end of study (up to overall period of 12 years)
Percentage of participants with pulmonary hypertension
Measured: up to the end of study (up to overall period of 12 years)
Percentage of participants with overall composite pulmonary complications
Measured: up to the end of study (up to overall period of 12 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startJan 2000
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 4,557 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784808
- Sponsor's protocol ID
- GA29396
- Status last verified
- Jun 2016
- First submitted
- 25 May 2016
- Last updated
- 8 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT02784808
- Acronym / sponsor ID
- GA29396
- Conditions
- Juvenile Idiopathic Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,557 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2000
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biologic DMARDs | – | Drug: Biological DMARDsParticipants who received biologic DMARDs as per standard of care were included in this arm. |
| Non-biological DMARDs | – | Drug: Non-Biologic DMARDsParticipants who received non-biologic DMARDs as per standard of care were included in this arm. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- JIA participants treated with biologic and non-biologic DMARDs from the Thomson Reuters MarketScan® Commercial Claims and Medicare Supplemental Databases
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological DMARDsParticipants will receive biologic DMARDs as per standard of CARE. The choice of specific biologic DMARD will be at the descretion of treating physician. | Drug | Biologic DMARDs |
| Non-Biologic DMARDsParticipants 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. | Drug | Non-biological DMARDs |
Primary outcome
Percentage of participants with pulmonary arterial hypertension
Time frame: up to the end of the study (up to overall period of 12 years)
5 secondary outcomes
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 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 overall composite pulmonary complications
Time frame: up to the end of study (up to overall period of 12 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
Questions about this trial
What is this clinical trial studying?
An observational study of Juvenile Idiopathic Arthritis, run by Hoffmann-La Roche.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with pulmonary arterial hypertension (time frame: up to the end of the study (up to overall period of 12 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2016.