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Use of Immunosuppressive Therapy for Sarcoidosis

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.
 
ClinicalTrials.gov Identifier: NCT02356445
Recruitment Status : Unknown
Verified August 2017 by Robert P Baughman, University of Cincinnati.
Recruitment status was:  Recruiting
First Posted : February 5, 2015
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Robert P Baughman, University of Cincinnati

Study Description
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Brief Summary:
Retrospective review of the outcome of use of immunosuppressive drugs in treatment of sarcoidosis

Condition or disease Intervention/treatment
Sarcoidosis Other: Cytotoxic drug

Detailed Description:
Patients receiving one or more cytotoxic or other immunosuppressive drug will be observed
Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Outcome of Use of Cytotoxic Drugs for Inflammatory Lung Diseases
Study Start Date : November 2014
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Cytotoxic drug
Patients treated for sarcoidosis
 Other: Cytotoxic drug
Observe patients versus treatment type
Other Name: Methotrexate, azathioprine, infliximab, Acthar


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Outcome [ Time Frame: 2 years ]
    Number of participants with improvement over two years


Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 2 years ]
    Number of participants with adverse events


Biospecimen Retention:   Samples Without DNA
serum in some cases

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with sarcoidosis treated
Criteria

Inclusion Criteria:

Any patient treated for sarcoidosis

Exclusion Criteria:

  • None
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02356445


Contacts
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Contact: Robert P Baughman, MD 513-584-5225 bob.baughman@uc.edu
Contact: Felicia Thompson 513-584-5226 thompsonf@ucmail.uc.edu

Locations
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United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Robert P Baughman, MD    513-584-5225    bob.baughman@uc.edu   
Contact: Elyse E Lower    513-584-3829    ELower@ohcmail.com   
Sponsors and Collaborators
University of Cincinnati
Investigators
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Principal Investigator: Robert P Baughman, MD University of Cincinnati
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Robert P Baughman, Professor of Medicine, University of Cincinnati
ClinicalTrials.gov Identifier: NCT02356445    
Other Study ID Numbers: UCincinnati
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Sarcoidosis
Methotrexate
Lymphoproliferative Disorders
Lymphatic Diseases
Azathioprine
Infliximab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Gastrointestinal Agents