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Search / Trial NCT04966884

The Efficacy and Safety of JAK Inhibitor in the Treatment of Anti-MDA5 Antibody-positive Dermatomyositis Patients

Launched by FIRST AFFILIATED HOSPITAL XI'AN JIAOTONG UNIVERSITY · Jul 15, 2021

Trial Information

Current as of May 01, 2025

Unknown status

Keywords

Dermatomyositis,Tofacitinib,Anti Mda5 Antibody

ClinConnect Summary

Dermatomyositis (DM) is an idiopathic inflammatory myopathy characterized by chronic inflammation in the skin and muscle. Anti-melanoma differentiation-associated gene5 (Anti-MDA5) antibody positive DM is a subtype of DM that is more frequent in East Asia, which is often exhibit skin lesion, clinically amyopathic and interstitial lung disease. About 42%-100% of patients with Anti-MDA5+ DM develop rapidly progressive interstitial lung disease (RPILD) and result in respiratory failure. The mortality is as high as 40% within 6 months. In addition, not every patient with Anti-MDA5+ DM respond t...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • patients fulfilled the Bohan and Peter criteria;
  • anti-MDA5 antibody positive;
  • patients who were not receiving treatment, or previously diagnosed with anti- MDA5-positive DM, who did not use biological agents (including but not limited to rituximab, infliximab, adalimumab, etanercept, tofacitinib, etc.) at the time of screening, or who had stopped taking drugs for ≥3 months;
  • Exclusion Criteria:
  • patients if they had other connective tissue diseases, an underlying cancer, a concomitant infection, or a liver aminotransferase level greater than 2 times the upper limit of the normal range.

About First Affiliated Hospital Xi'an Jiaotong University

The First Affiliated Hospital of Xi'an Jiaotong University is a leading medical institution renowned for its commitment to advancing healthcare through clinical research and innovative treatment approaches. As a prominent academic hospital in China, it integrates clinical practice, education, and research, fostering a collaborative environment that enables the development of cutting-edge therapies and medical technologies. With a multidisciplinary team of experts and state-of-the-art facilities, the hospital plays a pivotal role in conducting high-quality clinical trials that aim to improve patient outcomes and contribute to the global medical community.

Locations

Xi'an, Shaanxi, China

Patients applied

0 patients applied

Trial Officials

Lan He

Study Chair

First Affiliated Hospital Xi'an Jiaotong University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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