NCT07775235 Treatment Response in Immune-mediated Myositis Associated Rapidly-progressing Interstitial Lung Disease
| NCT ID | NCT07775235 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Singapore General Hospital |
| Condition | Interstitial Lung Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-12-26 |
| Primary Completion | 2029-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-12-26 with a primary completion date of 2029-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Idiopathic inflammatory myopathies (IIM) are a group of autoimmune conditions characterized by inflammation of muscles with possible extra-muscular manifestations which can include skin and interstitial lung disease (ILD). IIM-associated ILD carries poor prognosis. Particular subtypes of IIM such as anti-melanoma differentiation-associated protein 5 positive (anti-MDA5+) dermatomyositis with ILD are most commonly associated with rapidly progressive-interstitial lung disease (RP-ILD). RP-ILD is defined as worsening dyspnoea on exertion, hypoxaemia, and presence of newly emerging or expanding ground glass opacities on radiographic or computed topography of chest imaging excluding drug or infectious cause. Particularly, patients with anti-MDA5+ dermatomyositis often have RP-ILD with high mortality of over 60% in the first six months of diagnosis. The mainstay of treatment is immunosuppression though there has been no highly efficacious therapy proven to date. Therefore, the overall goal is to improve patient outcomes in IIM-associated RP-ILD including those with anti-MDA5+ dermatomyositis through the development of better treatment regimens. The objective of this research study is to evaluate the efficacy and safety of a combined immunosuppressive regime in patients with IIM-associated RP-ILD. The investigators hypothesize that the simultaneous inhibition of particular targets in the innate and adaptive immune system will improve efficacy and patient survival. The approach involves a combination of four immunosuppressive medications targeting different pathways implicated in IIM associated ILD. If successful, this study could contribute significantly to improving clinical outcomes for patients with IIM-associated RP-ILD.
Eligibility Criteria
Inclusion Criteria: 1. Age of 21 years or above; 2. Diagnosis of myositis associated rapidly progressive interstitial lung disease Exclusion Criteria: 1. Age of less than 21 year old;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07775235 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying Interstitial Lung Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07775235 currently recruiting?
Yes, NCT07775235 is actively recruiting participants. Contact the research team at mohamad.fadhli@mohh.com.sg for enrollment information.
Where is the NCT07775235 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT07775235 clinical trial?
NCT07775235 is sponsored by Singapore General Hospital. The trial plans to enroll 80 participants.