Taper Or Abrupt Steroid Stop: TOASSTtrial

Last updated: January 16, 2025
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Active - Recruiting

Phase

4

Condition

Inflammation

Treatment

Placebo Arm

Prednisone

Clinical Study ID

NCT03153527
2016-00487; ex14Rutishauser
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 cumulativeglucocorticoid dose ≥ 420 mg prednisone-equivalent prior to inclusion

  • Tapering not or no longer mandatory to treat underlying disease

Exclusion

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 childbearingpotential, not using and not willing to continue using a medically reliable methodof contraception for the entire study duration, such as oral, injectable, orimplantable contraceptives, or intrauterine contraceptive devices, or who are notusing any other method considered sufficiently reliable by the investigator inindividual 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 dayspreceding and during the present study,

  • Previous enrolment into the current study,

  • Enrolment of the investigator, his/her family members, employees and other dependentpersons

Study Design

Total Participants: 573
Treatment Group(s): 2
Primary Treatment: Placebo Arm
Phase: 4
Study Start date:
May 31, 2017
Estimated Completion Date:
December 31, 2026

Study 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

Connect with a study center

  • University Hospital Frankfurt

    Frankfurt,
    Germany

    Active - Recruiting

  • University Hospital Würzburg

    Würzburg, 97080
    Germany

    Active - Recruiting

  • Departement of Internal Medicine, Kantonsspital Aarau

    Aarau, 5001
    Switzerland

    Active - Recruiting

  • Kantonsspital Baden

    Baden, 5404
    Switzerland

    Active - Recruiting

  • Endocrinology/Diabetology/Metabolism; University Hospital Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

  • Department of Rheumatology, Immunology, and Allergology, Inselspital

    Bern, 3010
    Switzerland

    Active - Recruiting

  • Kantonsspital Baselland/Bruderholz

    Bruderholz, 4101
    Switzerland

    Site Not Available

  • Division of Gastroenterology, Spital Bülach AG

    Bülach, 8180
    Switzerland

    Active - Recruiting

  • Kantonsspital Frauenfeld

    Frauenfeld, 8501
    Switzerland

    Active - Recruiting

  • Geneva University Hospitals

    Geneva, 1205
    Switzerland

    Active - Recruiting

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

    Liestal, 4410
    Switzerland

    Active - Recruiting

  • Internal Medicine, Kantonsspital Baselland/Liestal

    Liestal, 4410
    Switzerland

    Active - Recruiting

  • Departement of Internal medicine, Luzerner Kantonsspital

    Luzern 16, 6000
    Switzerland

    Site Not Available

  • Department of Internal Medicine, Kantonsspital Münsterlingen

    Münsterlingen, 8596
    Switzerland

    Active - Recruiting

  • Stoffwechselzentrum, Kantonsspital Olten

    Olten, 4600
    Switzerland

    Active - Recruiting

  • Department of Internal Medicine, Kantonsspital St. Gallen

    St. Gallen, 9007
    Switzerland

    Active - Recruiting

  • GZO Spital Wetzikon

    Wetzikon, 8620
    Switzerland

    Site Not Available

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

    Zürich, 8091
    Switzerland

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.