Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-27 @ 11:16 PM
Study NCT ID:
NCT06488703
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-17
First Post:
2024-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Analysis of Systemic Glucocorticoid Mediated Long-term Effects, Patient Pathways and Economic Burden Across Multiple Indications
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Retrospective Analysis of Systemic Glucocorticoid Mediated Long-term Effects, Patient Pathways and Economic Burden Across Multiple Indications [PROGRESS Study]
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Glucocorticoids are important in the treatment of many inflammatory, allergic, immunologic, and malignant disorders. However, the adverse effects of systemic corticosteroids are one of the most common causes of iatrogenic conditions associated with chronic inflammatory diseases. Limited data are available about long-term- Systemic (cortico)steroids / systemic glucocorticoids (SCS) related side effects. Oral (cortico)steroids / systemic glucocorticoids (OCS) mediated side effects in e.g., rheumatic diseases are not consistently determined. No sufficient cohort analysis determined systematically possible side effects of SCS in the long-term. This study will close this major gap by delivering data about long-term SCS side effects (risk stratification via SCS dose, treatment duration). Therefore, the primary objective of PROGRESS is to quantify the risk of adverse outcomes among populations with specific underlying conditions (UC) with and without exposition to systemic glucocorticoid therapy in Germany. The secondary objective is to analyze the influence of dosage and time of systemic glucocorticoid therapy exposition on the risk of adverse outcomes among these populations with specific UCs. In general, it is evident that a frequent SCS exposure leads to side effects like diabetes or osteoporosis etc., which have the potential to become a major financial burden to healthcare systems. For this reason, the tertiary objective is to quantify the economic burden associated with the incidence of adverse outcomes related to SCS exposition among populations with specific UCs for the German market. The study design will be a retrospective cohort study (claims data) based on a rolling cohort design using an exact matching approach. Persons with different UCs and with SCS treatment exposition are matched to controls with UC but without SCS treatment. Matching will be performed on a quarterly basis. First patient-in is in 01/2009, last patient-in in 12/2020. The study period covers data from 01/2007 to 12/2022. The study population are adult patients with confirmed diagnosis of Bronchial Asthma, COPD, Chronic Arthritis und Rheumatism, Systemic lupus erythematosus, Vasculitis, Eosinophilic granulomatosis with polyangiitis (EGPA), Chronic rhinosinusitis (CRS), Crohn's disease, or Ulcerative colitis in Germany.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: