Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

Taper Or Abrupt Steroid Stop: TOASSTtrial

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

Taper Or Abrupt Steroid Stop: TOASSTtrial (NCT03153527) is a Phase 4 interventional studying Inflammatory Disorder and Autoimmune, sponsored by University Hospital, Basel, Switzerland. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This 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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 530 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - willing to sign a consent form as documented by signature (Appendix willing to sign a consent form 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 Should NOT Join This Trial: - 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 willing to sign a consent form - 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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.

OTHER

Placebo Arm

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

Locations (16)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University Hospital Frankfurt

Frankfurt, Germany

University Hospital Würzburg

Würzburg, Germany

Departement of Internal Medicine, Kantonsspital Aarau

Aarau, Switzerland

Kantonsspital Baden

Baden, Switzerland

Endocrinology/Diabetology/Metabolism; University Hospital Basel

Basel, Switzerland

St. Claraspital Basel

Basel, Switzerland

Department of Rheumatology, Immunology, and Allergology, Inselspital

Bern, Switzerland

Division of Gastroenterology, Spital Bülach AG

Bülach, Switzerland

Kantonsspital Frauenfeld

Frauenfeld, Switzerland

Geneva University Hospitals

Geneva, Switzerland

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

Liestal, Switzerland

Internal Medicine, Kantonsspital Baselland/Liestal

Liestal, Switzerland

Department of Internal Medicine, Kantonsspital Münsterlingen

Münsterlingen, Switzerland

Stoffwechselzentrum, Kantonsspital Olten

Olten, Switzerland

Department of Internal Medicine, Kantonsspital St. Gallen

Sankt Gallen, Switzerland

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

Zurich, Switzerland

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT03153527), the sponsor (University Hospital, Basel, Switzerland), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT03153527 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT03153527?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT03153527?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT03153527. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT03153527. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.