SarcoidosisREASNCT03769987
Registry for Advanced Sarcodiosis
An observational study of Sarcoidosis, run by University of Cincinnati at 1 site in United States.
Trial summary
Registry with evaluation and genetic information of patients with advanced sarcoidosis and matched sarcoidosis Read more about this study
- Who is it for?
- Ages 15 to 100 years
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- observation
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 30 Jun 2020
- How long will I take part?
- 2 Years
- 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 15 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Advanced sarcoidosis is defined by the presence of one or more of the following features: 1. Advanced pulmonary disease as defined by one or more of the following 2. Symptomatic cardiac disease due to sarcoidosis by either MRI or PET scanning and 3. Symptomatic neurologic disease 4. Patients who have received third line therapy (anti-TNF antibodies, rituximab, or RCI)
Who may be able to join
- Patients with diagnosis of sarcoidosis based on ATS/WASOG criteria 22
- Age ≥ 18 years.
- Life expectancy of at least 2 years.
- Pulmonary function tests (spirometry) within one month of entry or willing to under pulmonary function testing on the day of study enrollment
- Sarcoidosis as characterized as either advanced or non-advanced (see protocol for definition of advanced disease)
- Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
Who cannot join
- Subjects with a medical disorder, condition, or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator
- Inability to comply with the protocol and/or not willing or not available for follow-up assessments.
- Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45267
Robert P Baughman, MD, 513-584-5225, bob.baughman@uc.edu
Elyse E Lower, 513-584-3829, ELower@ucmail.uc.edu
About this study
Official title: Registry for Advanced Sarcoidosis
Registry with evaluation and genetic information of patients with advanced sarcoidosis and matched sarcoidosis
- Conditions
- Sarcoidosis
- Being tested
- observation
- Keywords
- neurosarcoidosis, pulmonary hyeprtension, infliximab, repository corticotropin
- Medical subject headings
- Sarcoidosis, Neurosarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
observe patients every 6 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Determine how many people die during follow up
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert P Baughman, University of Cincinnati
- Investigators
- Robert Baughman, Study chair, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769987
- Sponsor's protocol ID
- REAS
- Acronym
- REAS
- Status last verified
- Dec 2018
- First submitted
- 1 Feb 2018
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for Advanced Sarcoidosis
- ClinicalTrials.gov ID
- NCT03769987
- Acronym / sponsor ID
- REAS / REAS
- Conditions
- Sarcoidosis
- Keywords
- neurosarcoidosis, pulmonary hyeprtension, infliximab, repository corticotropin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 10 Dec 2018 (actual)
- 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.
Registry with evaluation and genetic information of patients with advanced sarcoidosis and matched sarcoidosis
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Advanced sarcoidosis is defined by the presence of one or more of the following features: 1. Advanced pulmonary disease as defined by one or more of the following 2. Symptomatic cardiac disease due to sarcoidosis by either MRI or PET scanning and 3. Symptomatic neurologic disease 4. Patients who have received third line therapy (anti-TNF antibodies, rituximab, or RCI)
Key inclusion criteria (6 listed)
- Patients with diagnosis of sarcoidosis based on ATS/WASOG criteria 22
- Age ≥ 18 years.
- Life expectancy of at least 2 years.
- Pulmonary function tests (spirometry) within one month of entry or willing to under pulmonary function testing on the day of study enrollment
- Sarcoidosis as characterized as either advanced or non-advanced (see protocol for definition of advanced disease)
Key exclusion criteria (3 listed)
- Subjects with a medical disorder, condition, or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator
- Inability to comply with the protocol and/or not willing or not available for follow-up assessments.
- Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
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 |
|---|---|---|
| observationobserve patients every 6 months | Other | – |
Primary outcome
Death
Time frame: 2 years
Determine how many people die during follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- Individual participant dataSharing planned: No
Related trials for Sarcoidosis
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Cardiac Sarcoidosis Multi-Center Prospective Cohort
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A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
Cutaneous Sarcoidosis
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An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
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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.
Robert Baughman study chair
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis, run by University of Cincinnati at 1 site in United States.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Baughman (513-584-5225, bob.baughman@uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: 2 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 10 Dec 2018.