Taper Or Abrupt Steroid Stop: TOASSTtrial

NCT03153527 | Recruiting Phase 4 DMC

• 2 other identifiers: 2016-00487; ex14Rutishauser2024-517334-18-00
• Study Type: interventional
• Target: 530
• Locations: 2 countries
• Sites: 16

Brief Summary

This study is an Investigator-initiated, placebo-controlled, multicenter noninferiority trial, comparing rapid termination of systemic glucocorticoid treatment with a tapering regime over 4 weeks.

Conditions

Inflammatory Disorder; Autoimmune

Outcome Measures

Primary Outcomes (1)

• Time to any incidence

  Time to first occurrence of hospitalization, death, initiation of unplanned systemic glucocorticoid therapy, or adrenal crisis (defined as glucocorticoid-responsive hypotension or shock with or without accompanying symptoms and signs such as weakness, apathy, nausea, vomiting, abdominal pain, hypothermia, hyponatremia \[serum sodium \< 135 millimole (mM)\], hyperkalemia \[serum potassium \> 5 mM\], hypoglycemia \[plasma glucose \< 3.5 mM\]); whichever occurs first.

  up to 6 months

Secondary Outcomes (8)

• Time to specific incidence

  up to 6 months

• Cumulative overall systemic glucocorticoid dose

  up to 6 months

• Cumulative systemic glucocorticoid dose administered to treat or prevent adrenal failure

  up to 6 months

• Cumulative systemic glucocorticoid dose administered to treat relapse

  up to 6 months

• General health status

  assessed at days 1, 7, 28, 35, 90,180

Study Arms (2)

Placebo arm (intervention arm)

PLACEBO COMPARATOR

Stop glucocorticoid treatment; administer placebo matching the verum preparation in weekly intervals.

Other: Placebo Arm

Verum group (control/standard arm)

ACTIVE COMPARATOR

If patient is on \> 7.5 mg prednisone-equivalent daily: administer 7.5 mg q.d. for 7 days, then 5 mg q.d. for 7 days, then 2.5 mg q.d. for 7 days, then 2.5 mg q.d. every second day, then stop. If patient on 7.5 mg q.d.: maintain for 7 days, then taper as above.

Drug: Prednisone

Interventions

Prednisone DRUG

The control intervention (standard treatment) consists of prednisone treatment in decreasing doses, starting with 7.5 mg q.d. and reducing the dose every 7 days, such that prednisone treatment is stopped after a total of 4 weeks.

Verum group (control/standard arm)

Placebo Arm OTHER

The experimental intervention consists of stopping glucocorticoid treatment abruptly and administering matching placebo over 4 weeks.

Placebo arm (intervention arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent as documented by signature (Appendix Informed Consent Form)
• Age ≥ 18 years
• Tapering not or no longer mandatory to treat underlying disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss National Science Foundation: collaborator
• University Hospital, Basel, Switzerland: lead
• Kantonsspital Baselland Bruderholz: collaborator
• HEMMI Stiftung Switzerland: collaborator
• Gebauer Stiftung Zurich: collaborator

Study Sites (16)

University Hospital Frankfurt

Frankfurt, Germany

RECRUITING

University Hospital Würzburg

Würzburg, 97080, Germany

RECRUITING

Departement of Internal Medicine, Kantonsspital Aarau

Aarau, 5001, Switzerland

RECRUITING

Kantonsspital Baden

Baden, 5404, Switzerland

RECRUITING

Endocrinology/Diabetology/Metabolism; University Hospital Basel

Basel, 4031, Switzerland

TERMINATED

St. Claraspital Basel

Basel, 4058, Switzerland

RECRUITING

Department of Rheumatology, Immunology, and Allergology, Inselspital

Bern, 3010, Switzerland

TERMINATED

Division of Gastroenterology, Spital Bülach AG

Bülach, 8180, Switzerland

TERMINATED

Kantonsspital Frauenfeld

Frauenfeld, 8501, Switzerland

RECRUITING

Geneva University Hospitals

Geneva, 1205, Switzerland

RECRUITING

Center for Primary Health Care,University of Basel, Kantonsspital Baselland

Liestal, 4410, Switzerland

TERMINATED

Internal Medicine, Kantonsspital Baselland/Liestal

Liestal, 4410, Switzerland

RECRUITING

Department of Internal Medicine, Kantonsspital Münsterlingen

Münsterlingen, 8596, Switzerland

RECRUITING

Stoffwechselzentrum, Kantonsspital Olten

Olten, 4600, Switzerland

TERMINATED

Department of Internal Medicine, Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

Dept. of Endocrinology, Diabetology and Clinical Nutrition, University Hospital

Zurich, 8091, Switzerland

TERMINATED

Related Publications (1)

• Komminoth M, Donath MY, Hepprich M, Schuetz P, Blum CA, Mueller B, Reny JL, Gosselin P, Breville G, Brandle M, Henzen C, Leuppi JD, Kistler AD, Thurnheer R, Beuschlein F, Rudofsky G, Aeberli D, Villiger PM, Bohm S, Chifu I, Fassnacht M, Meyer G, Bojunga J, Cattaneo M, Sluka C, Schneider H, Rutishauser J; <<TOASST>> study group. Glucocorticoid withdrawal and glucocorticoid-induced adrenal insufficiency: Study protocol of the randomized controlled <<TOASST" (Taper Or Abrupt Steroid STop) multicenter trial. PLoS One. 2023 Apr 5;18(4):e0281585. doi: 10.1371/journal.pone.0281585. eCollection 2023.

  PMID: 37018188 DERIVED

MeSH Terms

Interventions

Prednisone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jonas Rutishauser, Prof MD

  Departement Medizin, Kantonsspital Baden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonas Rutishauser, Prof MD

CONTACT

+41-56-486 25 14; j.rutishauser@unibas.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding of trial participants, treating physicians, study doctors, study nurses, outcome assessors and data analysts will be ensured by using identical-looking placebo, packaged in identical vials as the prednisone verum. Vials will be labeled with "Prednisone or Placebo" in an identical fashion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Standard treatment arm: Prednisone, a synthetic glucocorticoid with intermediate duration of action (biological half-life 18-35 hrs). The detailed characteristics of the compound, marketed under several brand names, can be found at www.swissmedicinfo.ch: Prednison Streuli (Swissmedic registration number: 29349); Prednison Axapharm (Swissmedic registration number: 58761); Prednison Galepharm (Swissmedic registration number: 50821). Interventional treatment arm: matching placebo.

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 15, 2017
• Study Start: May 31, 2017
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (14); DE (2)