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Use of Immunosuppressive Therapy for Sarcoidosis

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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

Tracking Information
First Submitted Date November 3, 2014
First Posted Date February 5, 2015
Last Update Posted Date August 14, 2017
Study Start Date November 2014
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2015)
Clinical Outcome [ Time Frame: 2 years ]
Number of participants with improvement over two years
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 1, 2015)
Toxicity [ Time Frame: 2 years ]
Number of participants with adverse events
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Use of Immunosuppressive Therapy for Sarcoidosis
Official Title Outcome of Use of Cytotoxic Drugs for Inflammatory Lung Diseases
Brief Summary 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
serum in some cases
Sampling Method Non-Probability Sample
Study Population All patients with sarcoidosis treated
Condition Sarcoidosis
Intervention Other: Cytotoxic drug
Observe patients versus treatment type
Other Name: Methotrexate, azathioprine, infliximab, Acthar
Study Groups/Cohorts Cytotoxic drug
Patients treated for sarcoidosis
Intervention: Other: Cytotoxic drug
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 1, 2015)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Any patient treated for sarcoidosis

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02356445
Other Study ID Numbers UCincinnati
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Robert P Baughman, University of Cincinnati
Study Sponsor University of Cincinnati
Collaborators Not Provided
Investigators
Principal Investigator: Robert P Baughman, MD University of Cincinnati
PRS Account University of Cincinnati
Verification Date August 2017