Clinical Trial

Renal Manifestations During Idiopathic Inflammatory Myopathies

Study acronym: IIM
Unknown
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Record status
This record was last updated April 1, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-02
Trial Details
NCT Number NCT06904937
Lead Sponsor University Hospital, Strasbourg, France
Conditions Inflammatory Myopathy
Enrollment 15 participants
Start Date 2024-01-05
Primary Completion 2025-12 (estimated)
Study Completion 2025-12-05 (estimated)
Updated on ClinicalTrials.gov 2025-04-01