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
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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