ClinicalTrials.gov record NCT03092180

Optimizing Treatment on Idiopathic Inflammatory Myopathies

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Optimizing Treatment on Idiopathic Inflammatory Myopathies

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationBrazil
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a prospective observational study that follows people with idiopathic inflammatory myopathies treated according to an internal routine protocol. It compares two groups at disease onset: intravenous methylprednisolone with or without human intravenous immunoglobulin versus intravenous methylprednisolone alone. Patients are assessed over about six months using clinical scores, muscle strength tests, blood tests, and muscle biopsy.

What it is studying. Whether outcomes and disease measures differ between two routine early intravenous treatment approaches (methylprednisolone with or without human intravenous immunoglobulin versus methylprednisolone alone) in people with idiopathic inflammatory myopathies. The study collects clinical activity scores, patient-reported disease activity, muscle strength, function questionnaires, muscle enzyme blood tests, muscle biopsy findings, and treatment side effects.

What the researchers hope to learn. To compare clinical and laboratory outcomes, muscle biopsy changes, and side effects between two early IV treatment approaches used at disease onset in idiopathic inflammatory myopathies. To collect data that may help understand how these routine approaches relate to disease activity, strength, function, enzymes, biopsy findings, and adverse effects.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

As a T2T, our patients with idiopathic inflammatory myopathies will receive pulse therapies with methyprednisolone and/or human intravenous immunoglobulin, or only methyprednisolone at disease onset. This scheme is an internal routine protocol of our Service.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Intravenous Infusion

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Idiopathic inflammatory myopathies

Exclusion criteria

  • Inclusion body myositis, muscular dystrophies, neoplasia-associated myopathies, overlapped myopathies, others myopathies

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

To compare two groups of patients as described in Brief Summary.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants receive the site's routine pulse therapy at disease onset: intravenous infusions of methyprednisolone alone or methyprednisolone plus human intravenous immunoglobulin. They will have a muscle biopsy under local anesthesia (Bergstrom needle) at baseline and again about 12 weeks later. Follow-up includes clinic assessments over six months: doctor and patient global activity scores, muscle strength testing, questionnaires (Health Assessment Questionnaire), blood tests for muscle enzymes, and monitoring for side effects.

How the study is structured. A prospective observational cohort. Participants receive the treating service's routine early-in-disease intravenous treatment (one of two approaches) rather than a study-assigned drug. The team follows participants with clinical exams, questionnaires, blood tests for muscle enzymes, and muscle biopsies (at baseline and again around 12 weeks), with key outcomes assessed through six months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in Brazil. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on dermatomyositis

This trial is also listed on this site under anti-synthetase syndrome and polymyositis.

Clinical trials59 trials listed for dermatomyositisEvery trial the registry lists for dermatomyositis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in dermatomyositis researchLatest monthly update: September 2026. Includes: Upadacitinib case reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
January 2005
Primary completion
May 6, 2024
Study completion
Dec 4, 2024 (estimated)
Target enrollment
60 participants (estimated)
Last updated on registry
Dec 5, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of Sao Paulo
Principal investigator
Samuel Katsuyuki Shinjo, PhD, Principal Investigator
University of Sao Paulo

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Samuel Katsuyuki ShinjoRecruiting

    São Paulo, 01246903 · Brazil

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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