Taper Or Abrupt Steroid Stop: TOASSTtrial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

573 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Inflammatory Disorder Autoimmune

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Standard treatment arm: Prednisone, a synthetic glucocorticoid with intermediate duration of action (biological half-life 18-35 hrs). The detailed characteristics of the compound, marketed under several brand names, can be found at www.swissmedicinfo.ch: Prednison Streuli (Swissmedic registration number: 29349); Prednison Axapharm (Swissmedic registration number: 58761); Prednison Galepharm (Swissmedic registration number: 50821).

Interventional treatment arm: matching placebo.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Blinding of trial participants, treating physicians, study doctors, study nurses, outcome assessors and data analysts will be ensured by using identical-looking placebo, packaged in identical vials as the prednisone verum. Vials will be labeled with "Prednisone or Placebo" in an identical fashion.

Study Groups

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Placebo arm (intervention arm)

Stop glucocorticoid treatment; administer placebo matching the verum preparation in weekly intervals.

Group Type PLACEBO_COMPARATOR

Placebo Arm

Intervention Type OTHER

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

Verum group (control/standard arm)

If patient is on \> 7.5 mg prednisone-equivalent daily: administer 7.5 mg q.d. for 7 days, then 5 mg q.d. for 7 days, then 2.5 mg q.d. for 7 days, then 2.5 mg q.d. every second day, then stop. If patient on 7.5 mg q.d.: maintain for 7 days, then taper as above.

Group Type ACTIVE_COMPARATOR

Prednisone

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Placebo Arm

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No