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An observation of tofacitinib in patients of MDA5+ clinically amyopathic dermatomyositis with interstitial lung disease

An observation of tofacitinib in patients of MDA5+ clinically amyopathic dermatomyositis with interstitial lung disease

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016629
Enrollment
Unknown
Registered
2018-06-14
Start date
2017-07-01
Completion date
Unknown
Last updated
2018-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dermatomyositis

Interventions

study group:tofacitinib
control group:glucocorticoids+immunosuppressant

Sponsors

Ren Ji Hospital South Campus, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. aged >18 years; 2. the patient or family members signed the informed consent voluntarily; 3. agreed to adopt effective contraceptive measures during the study period (child-bearing women); 4. MDA5 antibody positive; 5. disease duration of ILD less than 3 months; 6. impaired pulmonary function, while FVC=50%.

Exclusion criteria

Exclusion criteria: 1. merge with other connective tissue diseases or tumor; 2. patients with severe liver damage (liver enzyme > 2 times upper limit of normal; 3. patients are reluctant to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
;survival of 12 months;

Countries

China

Contacts

Public ContactWang Xiaodong

Ren Ji Hospital South Campus, Shanghai Jiaotong University School of Medicine

wangxiaodong@renji.com+86 13564082765

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026