The Prospective Observational Study for Realistically Concomitant Use of Corticosteroid in Idiopathic Pulmonary Fibrosis during Treatment with Anti-fibrotic Agents

The Prospective Observational Study for Realistically Concomitant Use of Corticosteroid in Idiopathic Pulmonary Fibrosis during Treatment with Anti-fibrotic Agents - Steroid Treatment for IPF Patients during Anti-fibrotic Agents Therapy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000038148

Enrollment

100

Registered

2019-10-01

Start date

2019-06-20

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

Idiopathic pulmonary fibrosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) A Patient who was clinically diagnosed with IPF (2) Having UIP or probable UIP pattern on HRCT based on the ATS/ERS/JRS/ALAT guideline in 2018 (3) FVC >=50% of predicted, DLCO >=30% of predicted, and FEV1 >=0.7. (4) Aged >=20 years and <=85 years (5) All grade of severity (GAP index and Japanese severity of IIPs) (6) A Patient who will receive nintedanib or pirfenidone or patients who was initiated to treatment with nintedanib or pirfenidone within 1 month (7) Patients who agree that they participate by written consent (8) The rate of lymphocyte is more than 30% (9) One or more the serum auto-immune-related markers, including RF, ANA, anti-DNA, anti-ARS, anti-scl-70, SS-A, SS-B, or ANCA) is positive

Exclusion criteria

Exclusion criteria: (1) Severe heart disease (2) AST >=1.5*ULN or ALT >=1.5*ULN, (3) T-bil >=1.5*ULN (4) Cr >=1.5*ULN (5) A patient who had ever received anti-cancer agents or radiation therapy (6) Pregnancy (7) A patient who can not receive pulmonary function test (8) A patient who already receive immunosuppressant, including azatiopurinn, cyclosporine, cyclophosphamide, methotrexate, tacrolimus) (9) Coexistence with pulmonary arterial hypertension, bronchial asthma, Malignant tumor, sarcoidosis, bronchiectasis, respiratory infection (10) A patient with risk of fatal bleeding (11) Past history of thrombosis (12) Having HBV antigen and HVB-DNA (13) A patient who started clinical trials less than 3 months (14) A patient improper to this clinical trial according to the decision of a principal investigator

Design outcomes

Primary

Measure	Time frame
Survival rate after 52 weeks	—

Countries

Japan

Contacts

Public ContactMotoyasu Kato

Juntendo University Hospital Department of Respiratory Medicine

mtkatou@juntendo.ac.jp03-3813-3111

Outcome results