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New treatment option for Inflammatory Disorder
Official title Taper Or Abrupt Steroid Stop: TOASSTtrial
ClinicalTrials.gov ID: NCT03153527
What this study is testing
What is Prednisone?
Prednisone is an investigational medicine, being studied as a potential treatment for inflammatory disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 4 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join 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,
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Frankfurt, Germany
- Würzburg, Germany
- Aarau, Switzerland
- Baden, Switzerland
- Basel, Switzerland
- Bern, Switzerland
- Bülach, Switzerland
- Frauenfeld, Switzerland
- Geneva, Switzerland
- Liestal, Switzerland
- Münsterlingen, Switzerland
- Olten, Switzerland
- Sankt Gallen, Switzerland
- Zurich, 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 study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Frankfurt, Germany; Würzburg, Germany; Aarau, Switzerland; Baden, Switzerland; Basel, Switzerland; Bern, Switzerland and 8 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.