Taper Or Abrupt Steroid Stop: TOASSTtrial (TOASST)

April 20, 2026 updated by: University Hospital, Basel, Switzerland

Glucocorticoid Withdrawal and Glucocorticoid-induced Adrenal Insufficiency: a Randomized Controlled Multicenter Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In total, 530 patients will be enrolled. Patients will be randomly assigned in a 1:1 ratio to either prednisone in decreasing doses over 4 weeks or placebo.

Patients, treating physicians, and study personnel will be blinded to treatment allocation to either prednisone or matching placebo. At inclusion, we will perform a 250 micrograms Synacthen® stimulation test. The results of the test will be blinded to treating physicians and investigators, and its value to predict clinical outcome will only be assessed after completion of the trial. As a safety measure, all patients will be instructed about stress coverage as well as signs and symptoms of hypocortisolism and will be provided with emergency medication. Patients will be randomized to the standard (tapering) or the experimental (matching placebo) arm. Follow-up will be for six months. In order to improve adherence to the study and ensure feasibility, follow-up visits in most study centers will be by telephone only. Visits will be performed early after stopping glucocorticoids in both arms (i.e. at days 7 and 35) to ensure safety; the other two visits will be on days 90 and 180.

Amendment approved in 1-2018: former exclusion criterion 'status post organ transplantation' was revised and deleted

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
530

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Frankfurt, Germany
        • Recruiting
        • University Hospital Frankfurt
        • Contact:
          • Jörg Bojunga, Prof. Dr. med.
        • Principal Investigator:
          • Jörg Bojunga, Prof. Dr. med.
        • Sub-Investigator:
          • Gesine Meyer, PD Dr. med.
      • Würzburg, Germany, 97080
        • Recruiting
        • University Hospital Wurzburg
        • Contact:
          • Irina Chifu, Dr. med.
        • Contact:
          • Martin Fassnacht, Prof Dr. med.
          • Phone Number: +49-931-201-39201
          • Email: Fassnacht_M@ukw.de
        • Sub-Investigator:
          • Martin Fassnacht, Prof Dr. med.
        • Principal Investigator:
          • Irina Chifu, Dr. med.
  • Switzerland
      • Aarau, Switzerland, 5001
        • Recruiting
        • Departement of Internal Medicine, Kantonsspital Aarau
        • Contact:
      • Baden, Switzerland, 5404
        • Recruiting
        • Kantonsspital Baden
        • Contact:
      • Basel, Switzerland, 4031
        • Terminated
        • Endocrinology/Diabetology/Metabolism; University Hospital Basel
      • Basel, Switzerland, 4058
        • Recruiting
        • St. Claraspital Basel
        • Contact:
        • Principal Investigator:
          • Matthias Hepprich
      • Bern, Switzerland, 3010
        • Terminated
        • Department of Rheumatology, Immunology, and Allergology, Inselspital
      • Bülach, Switzerland, 8180
        • Terminated
        • Division of Gastroenterology, Spital Bülach AG
      • Frauenfeld, Switzerland, 8501
        • Recruiting
        • Kantonsspital Frauenfeld
        • Contact:
        • Principal Investigator:
          • Andreas Kistler, PD Dr. med.
      • Geneva, Switzerland, 1205
        • Recruiting
        • Geneva University Hospitals
        • Contact:
          • Jean-Luc Reny, Prof. Dr. med.
          • Phone Number: +41 22 372 90 52
        • Principal Investigator:
          • Jean-Luc Reny, Prof. Dr. med.
      • Liestal, Switzerland, 4410
        • Recruiting
        • Internal Medicine, Kantonsspital Baselland/Liestal
        • Contact:
      • Liestal, Switzerland, 4410
        • Terminated
        • Center for Primary Health Care,University of Basel, Kantonsspital Baselland
      • Münsterlingen, Switzerland, 8596
        • Recruiting
        • Department of Internal Medicine, Kantonsspital Münsterlingen
        • Contact:
        • Principal Investigator:
          • Robert Thurnheer, Prof. Dr. med
      • Olten, Switzerland, 4600
        • Terminated
        • Stoffwechselzentrum, Kantonsspital Olten
      • Sankt Gallen, Switzerland, 9007
        • Recruiting
        • Department of Internal Medicine, Kantonsspital St. Gallen
        • Contact:
      • Zurich, Switzerland, 8091
        • Terminated
        • Dept. of Endocrinology, Diabetology and Clinical Nutrition, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo arm (intervention arm)
Stop glucocorticoid treatment; administer placebo matching the verum preparation in weekly intervals.
Other: Placebo Arm
The experimental intervention consists of stopping glucocorticoid treatment abruptly and administering matching placebo over 4 weeks.
Active Comparator: Verum group (control/standard arm)
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to any incidence
Time Frame: up to 6 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to specific incidence
Time Frame: up to 6 months
Time to first occurrence of individual components of the primary outcome;
up to 6 months
Cumulative overall systemic glucocorticoid dose
Time Frame: up to 6 months
Cumulative overall systemic glucocorticoid dose
up to 6 months
Cumulative systemic glucocorticoid dose administered to treat or prevent adrenal failure
Time Frame: 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
Time Frame: up to 6 months
Cumulative systemic glucocorticoid dose administered to treat relapse of disease, specified for each disease
up to 6 months
General health status
Time Frame: assessed at days 1, 7, 28, 35, 90,180
General health status as self-assessed by the participant on a visual analog scale (VAS) from 0 to 100
assessed at days 1, 7, 28, 35, 90,180
Score of symptoms and signs of hypocortisolism
Time Frame: up to 6 months
Score of symptoms and signs of hypocortisolism: weakness, hypothermia, nausea, vomiting, abdominal pain, fatigue, dizziness, Blood pressure, serum Na and serum glucose concentrations.
up to 6 months
Performance in 250 mcg Synacthen® test
Time Frame: up to 6 months
Performance in 250 mcg Synacthen® test: test assessed day 1 in all participants, plus days 7 and 35 in those followed in centers Bruderholz, Luzern, Aarau
up to 6 months
In patients hospitalized at study entry: length of hospital stay
Time Frame: up to 6 months
In patients hospitalized at study entry: length of hospital stay
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swiss National Science Foundation
Kantonsspital Baselland Bruderholz
HEMMI Stiftung Switzerland
Gebauer Stiftung Zurich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonas Rutishauser, Prof MD, Departement Medizin, Kantonsspital Baden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-00487; ex14Rutishauser
  • 2024-517334-18-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No sharing planned

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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