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Steroid withdrawal relief: new study tests hydrocortisone for exhausted patients

NCT ID NCT05193396

Symptom relief Sponsor: Marianne Andersen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a low dose of hydrocortisone (a cortisol-like hormone) can reduce symptoms like fatigue and dizziness in people who have recently stopped taking prednisolone for giant cell arteritis or polymyalgia rheumatica. About 100 adults aged 50 and older will receive either hydrocortisone or a placebo for 16 weeks. The goal is to see if this treatment improves quality of life during the recovery period.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Jan 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 50 years * A diagnosis of PMR or GCA in GC free remission for \>2 week and \<12 weeks after treatment with prednisolone (any dosage) for ≥12 weeks Exclusion Criteria: * Known primary or secondary adrenal insufficiency * Known Cushing´s syndrome * Heart failure (New York Heart Association class IV) * Kidney failure with an estimated glomerular filtration rate \<30 mL/min * Liver cirrhosis * Active cancer * Known severe immune deficiency * A history of psychiatric disease requiring treatment by a psychiatric department (for affective disorders only if within the last year before study entry) * Alcohol consumption \>21 units per week * Planned major surgery during the study period at study entry * Use of drugs that interfere with cortisol metabolism/measurements: * Systemic oestrogen treatment within 1 month before study inclusion * Strong CYP3A4 inhibitors or inducers * Use of other glucocorticoid formulations: inhaled, intra-articular or intramuscular injections, creams European steroid group IV applied in genital area * Permitted glucocorticoid formulations: eye-drops, nasal spray, creams European group I-III, and European group IV applied in non-genital area * Inability to provide written informed consent

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Conditions

The condition(s) this trial relates to.

adrenocortical insufficiency Giant Cell Arteritis polymyalgia rheumatica temporal arteritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adrenal insufficiency Giant cell arteritis (GCA) Polymyalgia rheumatica (PMR)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Endocrinology and Internal Medicine, Aarhus University Hospital

    RECRUITING

    Aarhus, Denmark

  • Department of Endocrinology, Odense University Hospital

    RECRUITING

    Odense, 5230, Denmark

  • Department of Nephrology and Endocrinology, Rigshospitalet

    RECRUITING

    Copenhagen, Denmark

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