Taper Or Abrupt Steroid Stop: TOASSTtrial (TOASST)

  • STATUS
    Recruiting
  • End date
    Dec 24, 2024
  • participants needed
    573
  • sponsor
    University Hospital, Basel, Switzerland
Updated on 24 May 2022

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.

Description

In total, 573 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

Details
Condition Inflammatory Disorder, Autoimmune
Treatment prednisone, Placebo Arm
Clinical Study IdentifierNCT03153527
SponsorUniversity Hospital, Basel, Switzerland
Last Modified on24 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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