A Study Using a Disease Registry to Observe the Long-term Effects of Nintedanib in People With Scleroderma-related Lung Fibrosis

Boehringer Ingelheim

Status: Active, not recruiting

Conditions: Interstitial Lung Diseases; Systemic Sclerosis Associated Interstitial Lung Disease

Treatments: Drug: Ofev®

Study type: Observational

Funder types: Industry

Identifiers

NCT07080125

EUPAS106792 (Registry Identifier)

1199-0421

Details and patient eligibility

About

This post-approval registry study is planned to generate data to address remaining questions on long-term effectiveness and to better characterize longer term beneficial effects of Nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) in terms of survival, quality of life, pattern of disease progression as well as effectiveness and safety in the subgroup of patients with pulmonary hypertension.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Enrolled in the EUSTAR registry
• Provided consent at their site to have their data included in the EUSTAR registry for a broad range of research studies, and agree to visit the site every 12 months
• Have a diagnosis of ILD defined by radiological findings on High Resolution Computed Tomography (HRCT) and/or X-ray that is documented in the electronic Case Report Form (eCRF) by the treating physician

Exclusion criteria

• Women with Systemic Sclerosis Interstitial Lung Disease (SSc-ILD) who are pregnant, or breastfeeding will be excluded since Ofev® is contraindicated for women who are pregnant due to safety concerns
• SSc-ILD patients aged <18 years: only adults will be included in the study since Ofev® is approved for treatment of SSc-ILD in adults
• Patients with a previous Hematopoietic Stem Cell Transplantation (HSCT)

Trial design

2,000 participants in 2 patient groups

Exposed group

Description:

Individuals that initiate Ofev® including either: 1. with an ongoing or new immunosuppressive therapy (IST) regimen (i.e., Ofev® combination therapy) or 2. after discontinuing an IST regimen or individuals that have never been on IST (i.e. Ofev® monotherapy)

Treatment:

Drug: Ofev®

Unexposed group

Description:

Individuals that do not initiate Ofev® during the study period and can include the following: 1. Individuals on an IST regimen, described as 1a) those without an IST treatment escalation and 1b) those with an IST treatment escalation (i.e., increased dose, additional IST, switch in IST) to treat ILD- or non-ILD related SSc organ manifestations (e.g., mycophenolate, cyclophosphamide, methotrexate, tocilizumab, rituximab, etc.) 2. Individuals who receive no IST