A Study to Estimate the Effect Sizes of HRCT Endpoints in Response to Glucocorticoid Induction Therapy in Subjects With Pulmonary Sarcoidosis

NCT03324503 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-02-26

No results posted yet for this study

Summary

This is a multicenter, single-arm, unblinded/open-label study of the effect size of HRCT endpoints in response to glucocorticoid induction therapy in subjects with a diagnosis of pulmonary sarcoidosis who have not received glucocorticoid as initial sarcoidosis therapy (≥ 20 mg/day prednisone or prednisolone) or other sarcoidosis therapy for at least 3 months prior to enrollment. This study will enroll a total of approximately 24 subjects.

Conditions

  • Sarcoidosis, Pulmonary

Interventions

DRUG

Glucocorticoid (prednisone or prednisolone)

≥ 30 mg/day prednisone or prednisolone taken orally as per local clinical practice of sarcoidosis initial induction therapy

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Gopal Krishna, PhD · Celgene

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-08
Primary Completion
2019-11-15
Completion
2019-11-15

Countries

  • United States
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03324503 on ClinicalTrials.gov