NCT02356445

Brief Summary

Retrospective review of the outcome of use of immunosuppressive drugs in treatment of sarcoidosis

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 14, 2017

Status Verified

August 1, 2017

Enrollment Period

4 years

First QC Date

November 3, 2014

Last Update Submit

August 10, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical Outcome

    Number of participants with improvement over two years

    2 years

Secondary Outcomes (1)

  • Toxicity

    2 years

Study Arms (1)

Cytotoxic drug

Patients treated for sarcoidosis

Other: Cytotoxic drug

Interventions

Observe patients versus treatment type

Also known as: Methotrexate, azathioprine, infliximab, Acthar
Cytotoxic drug

Eligibility Criteria

Age15 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with sarcoidosis treated

You may qualify if:

  • Any patient treated for sarcoidosis

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

Related Publications (2)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum in some cases

MeSH Terms

Conditions

Sarcoidosis

Interventions

CytotoxinsMethotrexateAzathioprineInfliximabAdrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

NoxaeToxic ActionsChemical Actions and UsesAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsThionucleosidesSulfur CompoundsOrganic ChemicalsMercaptopurinePurinesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsMelanocortinsPro-OpiomelanocortinHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesNeuropeptidesPeptidesNerve Tissue Proteins

Study Officials

  • Robert P Baughman, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert P Baughman, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

November 3, 2014

First Posted

February 5, 2015

Study Start

November 1, 2014

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

August 14, 2017

Record last verified: 2017-08

Locations