Actively Recruiting

Age: 18Years +
All Genders
NCT06904937

Renal Manifestations During Idiopathic Inflammatory Myopathies

Led by University Hospital, Strasbourg, France · Updated on 2025-04-01

15

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

There are currently no recommendations regarding treatments for Idiopathic Inflammatory Myopathies (IIM) due to the difficulty in conducting high-powered randomized controlled trials. Generally speaking, corticosteroids constitute one of the cornerstones of treatment and are, with some exceptions, always used at least in the initial phase of the disease. In general, this involves oral corticosteroid therapy initiated between 0.5 and 1.5 mg/kg/day followed by a gradual decrease after 4 to 6 weeks of treatment. It is generally necessary to introduce immunosuppressive treatment early with the aim of avoiding corticosteroids. The most commonly used as first-line treatment and having shown effectiveness in observational studies are methotrexate, azathioprine, mycophenolate mofetil and calcineurin inhibitors. In general, rituximab is reserved for severe forms refractory to several first-line immunosuppressants, and has shown some effectiveness during a randomized study. Likewise, cyclophosphamide is only considered in the most severe forms, generally rapidly progressive interstitial lung damage. More recently, Janus kinase inhibitors have been evaluated in several open-label and small-number studies, showing interesting effectiveness, particularly for refractory forms, as shown in this recent review of the literature. Immunoglobulins are the only treatment that has shown superiority compared to placebo in good quality randomized controlled studies. However, due to their cost and difficulty of access, they should be reserved for the severe form, particularly in cases of dysphagia, or refractory form. Apart from these medicinal treatments, it is necessary to add all the non-drug measures which are an integral part of the management of IIM. Performing regular physical activity helps prevent muscle loss and also has a beneficial effect on other comorbidities often present in patients and aggravated by corticosteroid therapy, such as cardiovascular risk factors, osteoporosis and resistance to 'insulin.

CONDITIONS

Official Title

Renal Manifestations During Idiopathic Inflammatory Myopathies

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years old or older
  • Diagnosed with inflammatory myopathy by ACR/EULAR 2017 criteria
  • Kidney biopsy performed
  • Treated at Strasbourg University Hospital between January 1, 1990 and May 1, 2023
  • No opposition expressed to reuse of data for scientific research
Not Eligible

You will not qualify if you...

  • Expressed opposition to participating in the study
  • Known cause of kidney damage other than inflammatory myopathy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Service de Rhumatologie - CHU de Strasbourg - France

Strasbourg, France, 67091

Actively Recruiting

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Research Team

A

Alain MEYER, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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