A Study to Estimate the Effect Sizes of HRCT Endpoints in Response to Glucocorticoid Induction Therapy in Subjects With Pulmonary Sarcoidosis
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|ClinicalTrials.gov Identifier: NCT03324503|
Recruitment Status : Not yet recruiting
First Posted : October 27, 2017
Last Update Posted : October 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sarcoidosis, Pulmonary||Drug: Glucocorticoid (prednisone or prednisolone)||Phase 1|
Optimal development of novel treatments for sarcoidosis requires clinical study endpoints that efficiently reflect changes in disease activity over short treatment durations. Such endpoints enable preliminary assessment of candidate drug efficacy in small studies - prior to exposing large cohorts to experimental compounds in pursuit of registrational data.
This study will accordingly investigate the ways that certain HRCT-based functional respiratory imaging (FRI) measures can serve as more quantitative and sensitive endpoints compared to pulmonary function tests to measure drug effect in a short duration small sample size study in patients with pulmonary sarcoidosis. The study is designed to minimize impact on sarcoid care that the patient would have otherwise received. Glucocorticoid (≥ 30 mg/day prednisone or prednisolone) as per local clinical practice of sarcoidosis initial induction therapy will be taken orally in this study. The glucocorticoid dose may be modified depending on ongoing assessment as a part of standard local clinical practice.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Open-label Study to Estimate the Effect Sizes of HRCT Endpoints in Response to Glucocorticoid Induction Therapy in Subjects With Pulmonary Sarcoidosis|
|Estimated Study Start Date :||October 31, 2017|
|Estimated Primary Completion Date :||November 30, 2018|
|Estimated Study Completion Date :||November 30, 2018|
Experimental: Glucocorticoid ≥ 30 mg/day
≥ 30 mg/day prednisone or prednisolone as per local clinical practice of sarcoidosis initial induction therapy will be taken orally preferably before, during, or immediately after meals or with food or milk, at approximately the same time of day for 8 weeks.
Drug: Glucocorticoid (prednisone or prednisolone)
≥ 30 mg/day prednisone or prednisolone taken orally as per local clinical practice of sarcoidosis initial induction therapy
Other Name: prednisone or prednisolone
- Change from baseline in high-resolution computed tomography (HRCT) [ Time Frame: Up to approximately 8 weeks ]Is defined as measurements of lobar volumes total lung capacity (TLC) in response to glucocorticoid induction therapy in subjects with pulmonary sarcoidosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324503
|Contact: Associate Director Clinical Trial Disclosureemail@example.com|
|Study Director:||Gopal Krishna, PhD||Celgene|