Comparing rapid steroid discontinuation to tapering in patients with inflammatory disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• St. Claraspital Basel
  Basel, Switzerland Recruiting
• Kantonsspital Frauenfeld
  Frauenfeld, Switzerland Recruiting

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.