Use of Immunosuppressive Therapy for Sarcoidosis | NCT02356445

Studies
Use of Immunosuppressive Therapy for Sarcoidosis

NCT02356445

Sponsor

University of Cincinnati

Status

Unknown status

Last Update Posted

Aug 14, 2017Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Sarcoidosis

Interventions

Cytotoxic drug

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Nov 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Nov 3, 2014

First Submission Date that Met QC Criteria

Feb 1, 2015

First Posted Date

Feb 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 10, 2017

Last Update Posted Date

Aug 14, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Robert P Baughman, Professor of Medicine, University of CincinnatiPrincipal Investigator

Lead Sponsor

University of CincinnatiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cytotoxic drug		Patients treated for sarcoidosis	Other: Cytotoxic drug

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cytotoxic drug	Other	Observe patients versus treatment type	Cytotoxic drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Outcome	Number of participants with improvement over two years	2 years

Secondary Outcomes

Measure	Description	Time Frame
Toxicity	Number of participants with adverse events	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any patient treated for sarcoidosis

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

90 Years

Standard Ages

ChildAdultOlder Adult

Study Population

All patients with sarcoidosis treated

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Robert P Baughman, MD	Contact	513-584-5225		bob.baughman@uc.edu
Felicia Thompson	Contact	513-584-5226		thompsonf@ucmail.uc.edu

Overall Officials

Name	Affiliation	Role
Robert P Baughman, MD	University of Cincinnati	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Cincinnati	Recruiting	Cincinnati	Ohio	45267	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34255140	Derived	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.
27614001	Derived	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.

ID	Term
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D006968	Hypersensitivity, Delayed

ID	Term
D003603	Cytotoxins
D008727	Methotrexate
D001379	Azathioprine
D000069285	Infliximab
D000324	Adrenocorticotropic Hormone

ID	Term
D009676	Noxae
D004786	Toxic Actions
D020164	Chemical Actions and Uses
D000630	Aminopterin