An observation of Pirfenidone in patients with rapidly progressive interstitial lung disease secondary to clinically amyopathic dermatomyositis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-16007958

Enrollment

Unknown

Registered

2016-02-21

Start date

2014-06-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

clinically amyopathic dermatomyositis

Interventions

Rsearch group: glucocorticoids+immunosuppressant+pirfenidone

Control group: glucocorticoids+immunosuppressant

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. aged >16 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. disease rapid progression within six months (according to the 2011 guideline for IPF: progressive dyspnea, HRCT shows deteriorate of pulmonary fibrosis, FVC decreases by 10% compared with baseline, DLCO decreases by 15% compared with baseline).

Exclusion criteria

Exclusion criteria: 1. merge with other connective tissue diseases; 2. merge with tumor; 3. patients with severe liver damage (liver enzyme > 2 times upper limit of normal; 4. patients are reluctant to sign the informed consent.

Design outcomes

Primary

Measure	Time frame
survival of 6 months;survival of 12 months;	—

Secondary

Measure	Time frame
HRCT score of lung;FVC;	—

Countries

China

Contacts

Public ContactYe Shuang

yeshuang_2000@163.com+86 021-34506393

Outcome results

None listed

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