- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02356445
Use of Immunosuppressive Therapy for Sarcoidosis
August 10, 2017 updated by: Robert P Baughman, University of Cincinnati
Outcome of Use of Cytotoxic Drugs for Inflammatory Lung Diseases
Retrospective review of the outcome of use of immunosuppressive drugs in treatment of sarcoidosis
Study Overview
Detailed Description
Patients receiving one or more cytotoxic or other immunosuppressive drug will be observed
Study Type
Observational
Enrollment (Anticipated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
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Cincinnati, Ohio, United States, 45267
- Recruiting
- University of Cincinnati
-
Contact:
- Elyse E Lower
- Phone Number: 513-584-3829
- Email: ELower@ohcmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 90 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients with sarcoidosis treated
Description
Inclusion Criteria:
Any patient treated for sarcoidosis
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cytotoxic drug
Patients treated for sarcoidosis
|
Observe patients versus treatment type
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Outcome
Time Frame: 2 years
|
Number of participants with improvement over two years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toxicity
Time Frame: 2 years
|
Number of participants with adverse events
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert P Baughman, MD, University of Cincinnati
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Zhou 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Anticipated)
November 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
November 3, 2014
First Submitted That Met QC Criteria
February 1, 2015
First Posted (Estimate)
February 5, 2015
Study Record Updates
Last Update Posted (Actual)
August 14, 2017
Last Update Submitted That Met QC Criteria
August 10, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Sarcoidosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
- Infliximab
- Azathioprine
Other Study ID Numbers
- UCincinnati
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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