SarcoidosisNCT02356445
Use of Immunosuppressive Therapy for Sarcoidosis
An observational study of Sarcoidosis, run by University of Cincinnati at 1 site in United States.
Trial summary
Retrospective review of the outcome of use of immunosuppressive drugs in treatment of sarcoidosis Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Sarcoidosis
- What is being tested?
- Cytotoxic drug
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Dec 2018
- 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 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with sarcoidosis treated
Who may be able to join
- Any patient treated for sarcoidosis
Who cannot join
- None
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@ohcmail.com
About this study
Official title: Outcome of Use of Cytotoxic Drugs for Inflammatory Lung Diseases
Retrospective review of the outcome of use of immunosuppressive drugs in treatment of sarcoidosis
Read the detailed description
Patients receiving one or more cytotoxic or other immunosuppressive drug will be observed
- Conditions
- Sarcoidosis
- Being tested
- Cytotoxic drug
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytotoxic drugOther
Also called Methotrexate, azathioprine, infliximab, Acthar
Observe patients versus treatment type
| Study group | Role | What they receive |
|---|---|---|
| Cytotoxic drug | Patients treated for sarcoidosis Receives: Other: Cytotoxic drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Outcome
Number of participants with improvement over two years
Measured: 2 years
Secondary outcomes (1)
Toxicity
Number of participants with adverse events
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 posted5 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
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 P Baughman, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356445
- Sponsor's protocol ID
- UCincinnati
- Status last verified
- Aug 2017
- First submitted
- 3 Nov 2014
- Last updated
- 14 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Baughman RP, Kotzin J, Lower EE. The Value of a Patient Global Assessment in Management of Sarcoidosis. Lung. 2021 Aug;199(4):357-362. doi: 10.1007/s00408-021-00455-5. Epub 2021 Jul 13.
PubMed 34255140Zhou Y, Lower EE, Li HP, Costea A, Attari M, Baughman RP. Cardiac Sarcoidosis: The Impact of Age and Implanted Devices on Survival. Chest. 2017 Jan;151(1):139-148. doi: 10.1016/j.chest.2016.08.1457. Epub 2016 Sep 8.
PubMed 27614001
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Use of Cytotoxic Drugs for Inflammatory Lung Diseases
- ClinicalTrials.gov ID
- NCT02356445
- Acronym / sponsor ID
- UCincinnati
- Conditions
- Sarcoidosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Feb 2015 (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.
Retrospective review of the outcome of use of immunosuppressive drugs in treatment of sarcoidosis
Detailed description
Patients receiving one or more cytotoxic or other immunosuppressive drug will be observed
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cytotoxic drug | – | Other: Cytotoxic drugPatients treated for sarcoidosis |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with sarcoidosis treated
Key inclusion criteria (1 listed)
- Any patient treated for sarcoidosis
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Cytotoxic drugAlso: Methotrexate, azathioprine, infliximab, ActharObserve patients versus treatment type | Other | Cytotoxic drug |
Primary outcome
Clinical Outcome
Time frame: 2 years
Number of participants with improvement over two years
1 secondary outcome
Toxicity
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
- Derived from this study: PubMed 34255140Baughman RP, Kotzin J, Lower EE. The Value of a Patient Global Assessment in Management of Sarcoidosis. Lung. 2021 Aug;199(4):357-362. doi: 10.1007/s00408-021-00455-5. Epub 2021 Jul 13.
- Derived from this study: PubMed 27614001Zhou Y, Lower EE, Li HP, Costea A, Attari M, Baughman RP. Cardiac Sarcoidosis: The Impact of Age and Implanted Devices on Survival. Chest. 2017 Jan;151(1):139-148. doi: 10.1016/j.chest.2016.08.1457. Epub 2016 Sep 8.
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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 P Baughman, MD principal investigator
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 1 inclusion and 1 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 14 Aug 2017. 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 P Baughman, MD (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?
Clinical Outcome (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02356445, which also lists 2 linked publications.
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 14 Aug 2017.