Last updated: 06/19/2026 06:00:29
Retrospective analysis of systemic glucocorticoid mediated long-term effects, participant pathways and economic burden across multiple indications
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Retrospective analysis of systemic glucocorticoid mediated long-term effects, patient pathways and economic burden across multiple indications [PROGRESS study]
Trial description: 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 participant-in is in 01/2009, last participant-in in 12/2020. The study period covers data from 01/2007 to 12/2022. The study population are adult participant 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Percentage of participants with any adverse outcome per underlying condition
Timeframe: Up to 14 years
Percentage of participants with asthma having specific adverse outcomes
Timeframe: Up to 14 years
Percentage of participants with chronic obstructive pulmonary disease (COPD) having specific adverse outcome
Timeframe: Up to 14 years
Percentage of participants with rheumatoid arthritis having specific adverse outcome
Timeframe: Up to 14 years
Percentage of participants with systemic lupus erythematosus (SLE) having specific adverse outcome
Timeframe: Up to 14 years
Percentage of participants with chronic rhinosinusitis (CRS) having specific Adverse outcome
Timeframe: Up to 14 years
Percentage of participants with Crohn’s disease having specific adverse outcome
Timeframe: Up to 14 years
Percentage of participants with ulcerative colitis having specific adverse outcome
Timeframe: Up to 14 years
Percentage of participants with vasculitis having specific adverse outcome
Timeframe: Up to 14 years
Percentage of participants with eosinophilic granulomatosis with polyangiitis (EGPA) having specific adverse outcome
Timeframe: Up to 14 years
Secondary outcomes:
Mean dose per day until any incident adverse outcome in asthma participants
Timeframe: Up to 14 years
Mean dose per day until any incident adverse outcome in COPD participants
Timeframe: Up to 14 years
Mean dose per day until any incident adverse outcome in participants with rheumatoid arthritis
Timeframe: Up to 14 years
Mean dose per day until any incident adverse outcome in SLE participants
Timeframe: Up to 14 years
Mean dose per day until any incident adverse outcome in CRS participants
Timeframe: Up to 14 years
Mean dose per day until any incident adverse outcome in Crohn’s disease participants
Timeframe: Up to 14 years
Mean dose per day until any incident adverse outcome ulcerative colitis participants
Timeframe: Up to 14 years
Mean dose per day until any incident adverse outcome in vasculitis participants
Timeframe: Up to 14 years
Mean dose per day until any incident adverse outcome in EGPA participants
Timeframe: Up to 14 years
Time to occurrence of any adverse outcome in asthma participants
Timeframe: Up to 14 years
Time to occurrence of any adverse outcome in COPD participants
Timeframe: Up to 14 years
Time to occurrence of any adverse outcome in rheumatoid arthritis participants
Timeframe: Up to 14 years
Time to occurrence of any adverse outcome in SLE participants
Timeframe: Up to 14 years
Time to occurrence of any adverse outcome in CRS participants
Timeframe: Up to 14 years
Time to occurrence of adverse outcome in Crohn’s disease participants
Timeframe: Up to 14 years
Time to occurrence of any adverse outcome in ulcerative colitis participants
Timeframe: Up to 14 years
Time to occurrence of any adverse outcome in vasculitis participants
Timeframe: Up to 14 years
Time to occurrence of any adverse outcome in EGPA participants
Timeframe: Up to 14 years
Interventions:
Not applicable
Enrollment:
107032
Observational study model:
Cohort
Primary completion date:
2025-20-06
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab
Collaborators
Vandage GmbH
Study date(s)
July 2024 to June 2025
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Male or female, aged 18 years or older.
- Prevalent diagnosis of an underlying condition.
- 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
Inclusion and exclusion 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
Trial location(s)
Study documents
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2025-20-06
Actual study completion date
2025-20-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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