Inflammatory DisorderPhase 4TOASSTNCT03153527
Taper Or Abrupt Steroid Stop: TOASSTtrial
A Phase 4 study testing Prednisone in people with Inflammatory Disorder and Autoimmune, run by University Hospital, Basel, Switzerland at 16 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Disorder, Autoimmune
- What is being tested?
- Prednisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 530 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 31 May 2017to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 12Show fewer
- 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
Trial locations and contacts
16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 2 countries
Switzerland14 sites, 8 recruiting
- Recruiting
Departement of Internal Medicine, Kantonsspital Aarau
Aarau, 5001
Philip Schuetz, Prof Dr med, +41 62 838 95 24, schuetzph@gmail.com
- Recruiting
Kantonsspital Baden
Baden, 5404
Jonas Rutishauser, Prof. Dr. MD, +41-56-486 25 14, j.rutishauser@unibas.ch
- Terminated
Endocrinology/Diabetology/Metabolism; University Hospital Basel
Basel, 4031
- Recruiting
St. Claraspital Basel
Basel, 4058
Matthias Hepprich, +41 61 685 89 40, matthias.hepprich@claraspital.ch
Matthias Hepprich
- Terminated
Department of Rheumatology, Immunology, and Allergology, Inselspital
Bern, 3010
- Terminated
Division of Gastroenterology, Spital Bülach AG
Bülach, 8180
- Recruiting
Kantonsspital Frauenfeld
Frauenfeld, 8501
Andreas Kistler, PD Dr. med., +41 52 723 76 43, andreas.kistler@stgag.ch
Andreas Kistler, PD Dr. med.
- Recruiting
Geneva University Hospitals
Geneva, 1205
Jean-Luc Reny, Prof. Dr. med., +41 22 372 90 52
Jean-Luc Reny, Prof. Dr. med.
- Terminated
Center for Primary Health Care,University of Basel, Kantonsspital Baselland
Liestal, 4410
- Recruiting
Internal Medicine, Kantonsspital Baselland/Liestal
Liestal, 4410
Jörg Leuppi, Prof Dr med, +41-61-925 21 80, joerg.leuppi@ksbl.ch
- Recruiting
Department of Internal Medicine, Kantonsspital Münsterlingen
Münsterlingen, 8596
Robert Thurnheer, +41 71 686 21 75, robert.thurnheer@stgag.ch
Robert Thurnheer, Prof. Dr. med
- Terminated
Stoffwechselzentrum, Kantonsspital Olten
Olten, 4600
- Recruiting
Department of Internal Medicine, Kantonsspital St. Gallen
Sankt Gallen, 9007
Michael Brändle, Prof Dr med, +41-71-494 61 21, michael.braendle@kssg.ch
- Terminated
Dept. of Endocrinology, Diabetology and Clinical Nutrition, University Hospital
Zurich, 8091
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Frankfurt
Frankfurt
Jörg Bojunga, Prof. Dr. med.
Jörg Bojunga, Prof. Dr. med.
- Recruiting
University Hospital Würzburg
Würzburg, 97080
Irina Chifu, Dr. med.
Martin Fassnacht, Prof Dr. med., +49-931-201-39201, Fassnacht_M@ukw.de
About this study
Official title: 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.
Read the 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
- Conditions
- Inflammatory Disorder, Autoimmune
- Being tested
- Prednisone, Placebo Arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
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.
Placebo ArmOther
The experimental intervention consists of stopping glucocorticoid treatment abruptly and administering matching placebo over 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo arm (intervention arm) | Placebo comparator | Stop glucocorticoid treatment; administer placebo matching the verum preparation in weekly intervals. Receives: 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. Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Secondary outcomes (8)
Time to specific incidence
Time to first occurrence of individual components of the primary outcome;
Measured: up to 6 months
Cumulative overall systemic glucocorticoid dose
Cumulative overall systemic glucocorticoid dose
Measured: up to 6 months
Cumulative systemic glucocorticoid dose administered to treat or prevent adrenal failure
Cumulative systemic glucocorticoid dose administered to treat or prevent adrenal failure
Measured: up to 6 months
Cumulative systemic glucocorticoid dose administered to treat relapse
Cumulative systemic glucocorticoid dose administered to treat relapse of disease, specified for each disease
Measured: up to 6 months
General health status
General health status as self-assessed by the participant on a visual analog scale (VAS) from 0 to 100
Measured: assessed at days 1, 7, 28, 35, 90,180
Score of symptoms and signs of hypocortisolism
Score of symptoms and signs of hypocortisolism: weakness, hypothermia, nausea, vomiting, abdominal pain, fatigue, dizziness, Blood pressure, serum Na and serum glucose concentrations.
Measured: up to 6 months
Performance in 250 mcg Synacthen® test
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
Measured: up to 6 months
In patients hospitalized at study entry: length of hospital stay
In patients hospitalized at study entry: length of hospital stay
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start31 May 2017
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 530 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Baselland Bruderholz, Swiss National Science Foundation, HEMMI Stiftung Switzerland, Gebauer Stiftung Zurich
- Responsible party
- Sponsor
- Investigators
- Jonas Rutishauser, Prof MD, Principal investigator, Departement Medizin, Kantonsspital Baden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153527
- Sponsor's protocol ID
- 2016-00487; ex14Rutishauser
- Other IDs
- 2024-517334-18-00, 2016
- Acronym
- TOASST
- Status last verified
- Apr 2026
- First submitted
- 5 May 2017
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing planned
Publications
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.
PubMed 37018188
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucocorticoid Withdrawal and Glucocorticoid-induced Adrenal Insufficiency: a Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT03153527
- Acronym / sponsor ID
- TOASST / 2016-00487; ex14Rutishauser
- Conditions
- Inflammatory Disorder, Autoimmune
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 530 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Kantonsspital Baselland Bruderholz, Swiss National Science Foundation, HEMMI Stiftung Switzerland, Gebauer Stiftung Zurich
- Study start
- 31 May 2017 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Placebo arm (intervention arm) | Placebo comparator | Other: Placebo ArmStop glucocorticoid treatment; administer placebo matching the verum preparation in weekly intervals. |
| Verum group (control/standard arm) | Active comparator | Drug: PrednisoneIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoneThe 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. | Drug | Verum group (control/standard arm) |
| Placebo ArmThe experimental intervention consists of stopping glucocorticoid treatment abruptly and administering matching placebo over 4 weeks. | Other | Placebo arm (intervention arm) |
Primary outcome
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.
8 secondary outcomes
Time to specific incidence
Time frame: up to 6 months
Cumulative overall systemic glucocorticoid dose
Time frame: 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 relapse
Time frame: up to 6 months
General health status
Time frame: assessed at days 1, 7, 28, 35, 90,180
Score of symptoms and signs of hypocortisolism
Time frame: up to 6 months
Performance in 250 mcg Synacthen® test
Time frame: up to 6 months
In patients hospitalized at study entry: length of hospital stay
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Derived from this study: PubMed 37018188Komminoth 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.
- Individual participant dataSharing planned: No. No sharing planned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonas Rutishauser, Prof MD principal investigator
Departement Medizin, Kantonsspital Baden
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prednisone in people with Inflammatory Disorder and Autoimmune, run by University Hospital, Basel, Switzerland at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Switzerland, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonas Rutishauser, Prof MD (+41-56-486 25 14, j.rutishauser@unibas.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to any incidence (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03153527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.