Skip to content

Study on the Efficacy and Safety of Pirfenidone and Nintedanib in Connective Tissue Disease-Interstitial Lung Disease (CTD-ILD)

Study on the Efficacy and Safety of Pirfenidone and Nintedanib in Connective Tissue Disease-Interstitial Lung Disease (CTD-ILD)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098990
Enrollment
Unknown
Registered
2025-03-17
Start date
2025-03-17
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

Connective Tissue Disease- Interstitial lung Disease

Interventions

Observation group:None

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with connective tissue diseases that meet the latest international diagnostic classification standards for corresponding diseases; 2. According to the clinical manifestations, high-resolution CT features of the chest, and the results of pulmonary function tests, the diagnosis of interstitial lung disease was confirmed; 3. Age>=18 years old; 4. Voluntarily participate in this trial, have good compliance, and have the ability to understand and sign informed consent before the study.

Exclusion criteria

Exclusion criteria: 1. Patients with known infection with human immunodeficiency virus (HIV) at the time of screening, history of lymphoproliferative disorders or malignant tumors of any organ system within the past 5 years, and history of solid organ transplantation; 2. Females who are pregnant, breastfeeding, or planning to become pregnant during the trial; 3. Those who have undergone plasmapheresis within 3 months; 4. Patients with a known history of allergy to pirfenidone and nintedanib or serious adverse reactions; or patients with known allergies to peanuts, soy, or other excipients; 5. Those who take fluvoxamine at the same time (combined with pirfenidone, it can lead to obvious drug interactions, and its clearance rate can be significantly reduced).

Design outcomes

Primary

MeasureTime frame
Progression of lung function ( absolute decrease of FVC in predicted value = 10 % or death );Survival;

Secondary

MeasureTime frame
The incidence of adverse events and serious adverse events;Lung CT changes;

Countries

China

Contacts

Public ContactDong Lingli

Department of Rheumatology and Immunology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

tjhdongll@163.com+86 186 7291 2727

Outcome results

None listed

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