Clinical trial NCT06488703: Retrospective Analysis of Systemic Glucocorticoid Mediated Long-term Effects, Patient Pathways and Economic Burden Across Multiple Indications
Official title: Retrospective Analysis of Systemic Glucocorticoid Mediated Long-term Effects, Patient Pathways and Economic Burden Across Multiple Indications [PROGRESS Study]
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Asthma
Keywords: PROGRESS
Systemic (cortico)steroids / systemic glucocorticoids
Long term OCS side effects
OCS side effects
SCS side effects
Long term SCS side effects
Asthma
Chronic obstructive pulmonary disease (COPD)
Rheumatism
Lupus
Vasculitis
Eosinophilic granulomatosis with polyangiitis (EGPA)
Chronic rhinosinusitis with nasal polyps (CRSwNP)
Crohn's disease
Ulcerative colitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Vandage GmbH
First posted: 2024-07-05
Enrollment: 52000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will enroll participants who meets the below inclusion/exclusion criteria.

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.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 18 years or older.
* Prevalent diagnosis of an underlying condition.
* At least two years of pre observation period. The same inclusion criteria apply to the matched control group, excluding the initiation of Systemic (cortico)steroids / systemic glucocorticoids (SCS) treatment.

Exclusion Criteria:

* Have a record of defined SCS-related adverse outcome within two years before index date.
* Have a history of breast cancer and / or tamoxifen prescription

Primary outcomes:
measure: Percentage of Participants with specific Adverse outcome in patients with underlying condition (UC) with exposition of systemic glucocorticoids
timeFrame: Up to 7 months
measure: Percentage of Participants with any Adverse outcome in patients with underlying condition (UC) with exposition of systemic glucocorticoids
timeFrame: Up to 7 months
measure: Percentage of Participants with specific Adverse outcome in participants with UC without exposition of systemic glucocorticoids
timeFrame: Up to 7 months
measure: Percentage of Participants with any Adverse outcome in participants with UC without exposition of systemic glucocorticoids
timeFrame: Up to 7 months
Secondary outcomes:
measure: Percentage of Participants with specific Adverse outcome in the influence of systemic glucocorticoid therapy exposition related to dosage and time.
timeFrame: Up to 7 months
measure: Percentage of Participants with any Adverse outcome in the influence of systemic glucocorticoid therapy exposition related to dosage and time.
timeFrame: Up to 7 months
measure: Percentage of Participants with any Adverse outcome in the influence of systemic glucocorticoid therapy without exposition related to dosage and time.
timeFrame: Up to 7 months
Other outcomes:
Locations:
city: Germany
country: Germany
facility: Rwth Aachen University-Aachen-Germany-C
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: