Nintedanib treatment for the patients with systemic scleroderma-associated interstitial lung disease-a prospective observational study

Nintedanib treatment for the patients with systemic scleroderma-associated interstitial lung disease-a prospective observational study - Nintedanib for the patients with SSc-ILD

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000039605

Enrollment

100

Registered

2020-02-27

Start date

2020-02-21

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Systemic scleroderma-associated interstitial lung disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) A Patient who was clinically diagnosed with SSc (2) A Patient who was clinically diagnosed with SSc-ILD (3) A Patient who will receive nintedanib within 1 month (4) Aged >=20 years and <85 years (5) A patient who agree that they participate by written consent

Exclusion criteria

Exclusion criteria: (1) Difficulty obtaining patients' consent (2) Severe heart disease (3) AST >=2*ULN, ALT >=2*ULN, or T-bil >=2*ULN (4) Pregnancy (5) Complication with other CTD, RA, SLE,PM/DM, MCTD, SjS, Behcet's disease, and vasculitis (6) Coexistence with pulmonary arterial hypertension, bronchial asthma, Malignant tumor, sarcoidosis, bronchiectasis, respiratory infection (7) A patient who already receive nintedanib or other anti-fibrotic agents (8) A patient with risk of fatal bleeding (9) Past history of thrombosis less than 3 months (10) A patient who started clinical trials less than 3 months (11) A patient improper to this clinical trial according to the decision of a principal investigator

Design outcomes

Primary

Measure	Time frame
Decline of forced vital capacity after 48 weeks	—

Countries

Japan

Contacts

Public ContactMotoyasu Kato

Juntendo University Hospital Department of Respiratory Medicine

mtkatou@juntendo.ac.jp0338133111

Outcome results