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New tool could predict who will suffer from steroid side effects

NCT ID NCT04664465

Knowledge-focused Sponsor: University Hospital, Brest Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 aims to create a tool that predicts which patients with inflammatory rheumatic diseases (like rheumatoid arthritis, vasculitis, or polymyalgia rheumatica) will develop serious side effects from long-term steroid use. Researchers will collect routine medical data—such as blood tests, bone density scans, and patient history—from 300 people starting high-dose steroids. The goal is to build a simple score that helps doctors personalize treatment and reduce harm.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
glucocorticoid therapy (prednisone or equivalent)
What this could lead to
If successful, doctors could use a simple score to predict steroid side effects and tailor treatment plans for each patient.
What could go wrong
This is an observational study, not a treatment trial. The predictive score may not be accurate enough for routine use and needs further validation.

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.

Participants

About 300 people

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

Started

Mar 2021

Expected to finish

Sep 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.

Who is studied

Patients usually treated with prolonged glucocorticoid therapy in the field of rheumatology.

Ages

18 to 85 years

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: * Life expectancy \> 1 year. * Indication to initiate prolonged glucocorticoid therapy at a dosage ≥ 15 mg/day for the treatment of an inflammatory rheumatic disease. * Initial treatment or relapse. * Previsional treatment duration \> 3 months. Exclusion Criteria: * Unable to consent. * Previous corticosteroid therapy in the last 3 months at a significant dosage (\> 5 mg per day).

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Conditions

The condition(s) this trial relates to.

acquired idiopathic inflammatory myopathy anti-neutrophil cytoplasmic antibody-associated vasculitis autoimmune disease Giant Cell Arteritis granulomatosis with polyangiitis myositis disease polymyalgia rheumatica rheumatic disorder rheumatic fever temporal arteritis

As listed by the trial registrant

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

ANCA associated vasculitis Giant cell arteritis Idiopathic inflammatory myopathies Inflammatory rheumatism Polymyalgia rheumatica Systemic autoimmune disease

Contacts and locations

Locations

  • <CHU de Poitiers

    Poitiers, France

  • CH Le Mans

    Le Mans, 72000, France

  • CH des Pays de Morlaix

    Morlaix, 29672, France

  • CHD Vendée

    La Roche-sur-Yon, 85925, France

  • CHIC Quimper

    Quimper, 29000, France

  • CHR d'Orléans

    Orléans, 45067, France

  • CHRU de Brest

    Brest, 29609, France

  • CHU d'Angers

    Angers, 49933, France

  • CHU de Nantes - Service de Médecine interne

    Nantes, 44093, France

  • CHU de Nantes - Service de Rhumatologie

    Nantes, 44093, France

  • CHU de Tours

    Tours, 37044, France

  • Clinique St Exupéry

    Toulouse, France

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