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Registry for Advanced Sarcodiosis (REAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03769987
Recruitment Status : Unknown
Verified December 2018 by Robert P Baughman, University of Cincinnati.
Recruitment status was:  Recruiting
First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati

Brief Summary:
Registry with evaluation and genetic information of patients with advanced sarcoidosis and matched sarcoidosis

Condition or disease Intervention/treatment
Sarcoidosis Other: observation

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 800 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Registry for Advanced Sarcoidosis
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Intervention Details:
  • Other: observation
    observe patients every 6 months

Primary Outcome Measures :
  1. Death [ Time Frame: 2 years ]
    Determine how many people die during follow up

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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)

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03769987

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Contact: Robert Baughman 513-584-5225

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United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Robert P Baughman, MD    513-584-5225   
Contact: Elyse E Lower    513-584-3829   
Sponsors and Collaborators
University of Cincinnati
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Study Chair: Robert Baughman University of Cincinnati
Additional Information:

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Responsible Party: Robert P Baughman, Professor, University of Cincinnati Identifier: NCT03769987    
Other Study ID Numbers: REAS
First Posted: December 10, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert P Baughman, University of Cincinnati:
neurosarcoidosis, pulmonary hyeprtension, infliximab, repository corticotropin
Additional relevant MeSH terms:
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Lymphoproliferative Disorders
Lymphatic Diseases