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TOASST Study: Taper Or Abrupt Steroid STop?
EU CTIS ID: 2024-517334-18-00
What this study is testing
To perform the first adequately powered randomized, placebo controlled, multicenter noninferiority trial, comparing immediate termination of systemic glucocorticoid treatment with a tapering regime over four weeks. The hypothesis is tested that in patients treated with systemic glucocorticoids for various inflammatory disorders, rapid termination of treatment will not result in a worse clinical outcome than a tapering regime over four weeks.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Informed Consent as documented by signature
- Age ≥ 18 years
- Daily glucocorticoid dose ≥ 7.5 mg prednisone-equivalent at the time of inclusion
- Therapy over ≥ 28 days,
- ≥ 7.5 mg prednisone-equivalent average daily dose until time of inclusion,
- cumulative glucocorticoid dose ≥ 420 mg prednisoneequivalent prior to inclusion
You likely can't join if
- Primary adrenal failure
- 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, as defined by the Clinical Trial Facilitation Group for the entire study duration, i.e. hormonal contraception with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion.
- 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,
- Untreated hereditary galactose intolerance or lactase deficiency or glucose-galactose malabsorption.
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
See the full eligibility criteria
- Informed Consent as documented by signature
- Age ≥ 18 years
- Daily glucocorticoid dose ≥ 7.5 mg prednisone-equivalent at the time of inclusion
- Therapy over ≥ 28 days,
- ≥ 7.5 mg prednisone-equivalent average daily dose until time of inclusion,
- cumulative glucocorticoid dose ≥ 420 mg prednisoneequivalent prior to inclusion
- Tapering not or no longer mandatory to treat underlying disease
- Primary adrenal failure
- 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, as defined by the Clinical Trial Facilitation Group for the entire study duration, i.e. hormonal contraception with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion.
- 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,
- Untreated hereditary galactose intolerance or lactase deficiency or glucose-galactose malabsorption.
- 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
- 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,
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.