Comparing rapid steroid discontinuation to tapering in patients with inflammatory disorders
Glucocorticoid Withdrawal and Glucocorticoid-induced Adrenal Insufficiency: a Randomized Controlled Multicenter Trial
This study is testing whether stopping steroid treatment suddenly is safer and more effective than gradually reducing the dose for people with inflammatory disorders.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 530 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Drugs / interventions | prednisone |
| Locations | 16 sites (Frankfurt and 15 other locations) |
| Trial ID | NCT03153527 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and efficacy of abruptly stopping systemic glucocorticoid treatment compared to a gradual tapering approach over four weeks. A total of 573 patients will be randomly assigned to receive either a tapering dose of prednisone or a matching placebo, with both patients and healthcare providers blinded to the treatment allocation. The study includes a Synacthen® stimulation test at baseline to assess its predictive value for clinical outcomes, which will be evaluated after the trial's completion. Follow-up will occur over six months, primarily through telephone visits to enhance adherence and feasibility.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been on a daily glucocorticoid dose of at least 7.5 mg prednisone-equivalent for a minimum of 28 days.
Not a fit: Patients with primary adrenal failure or those requiring systemic depot glucocorticoids will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective method for discontinuing glucocorticoid therapy in patients with inflammatory disorders.
How similar studies have performed: While this approach is novel in its specific comparison, similar studies on glucocorticoid tapering have shown varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed Consent as documented by signature (Appendix Informed Consent Form) * Age ≥ 18 years * Daily glucocorticoid dose ≥ 7.5 mg prednisone-equivalent at the time of inclusion * Therapy over ≥ 28 days, ≥ 7.5 mg average daily dose, with a cumulative glucocorticoid dose ≥ 420 mg prednisone-equivalent prior to inclusion * Tapering not or no longer mandatory to treat underlying disease Exclusion Criteria: * Primary adrenal failure * Treatment with systemic depot glucocorticoids (e.g. intramuscular, epidural) * Incapability to administer glucocorticoid cover treatment in situations of stress * Inability or unwillingness to provide informed consent * Women who are pregnant or breast feeding, * Intention to become pregnant during the course of the study, * Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. * Known or suspected non-compliance * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * Participation in another study with investigational drug within the 30 days preceding and during the present study, * Previous enrolment into the current study, * Enrolment of the investigator, his/her family members, employees and other dependent persons
Where this trial is running
Frankfurt and 15 other locations
- University Hospital Frankfurt — Frankfurt, Germany (Recruiting)
- University Hospital Würzburg — Würzburg, Germany (Recruiting)
- Departement of Internal Medicine, Kantonsspital Aarau — Aarau, Switzerland (Recruiting)
- Kantonsspital Baden — Baden, Switzerland (Recruiting)
- Endocrinology/Diabetology/Metabolism; University Hospital Basel — Basel, Switzerland (Terminated)
- St. Claraspital Basel — Basel, Switzerland (Recruiting)
- Department of Rheumatology, Immunology, and Allergology, Inselspital — Bern, Switzerland (Terminated)
- Division of Gastroenterology, Spital Bülach AG — Bülach, Switzerland (Terminated)
- Kantonsspital Frauenfeld — Frauenfeld, Switzerland (Recruiting)
- Geneva University Hospitals — Geneva, Switzerland (Recruiting)
- Center for Primary Health Care,University of Basel, Kantonsspital Baselland — Liestal, Switzerland (Terminated)
- Internal Medicine, Kantonsspital Baselland/Liestal — Liestal, Switzerland (Recruiting)
- Department of Internal Medicine, Kantonsspital Münsterlingen — Münsterlingen, Switzerland (Recruiting)
- Stoffwechselzentrum, Kantonsspital Olten — Olten, Switzerland (Terminated)
- Department of Internal Medicine, Kantonsspital St. Gallen — Sankt Gallen, Switzerland (Recruiting)
- Dept. of Endocrinology, Diabetology and Clinical Nutrition, University Hospital — Zurich, Switzerland (Terminated)
Study contacts
- Principal investigator: Jonas Rutishauser, Prof MD — Departement Medizin, Kantonsspital Baden
- Study coordinator: Jonas Rutishauser, Prof MD
- Email: j.rutishauser@unibas.ch
- Phone: +41-56-486 25 14
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.