Non-interventional post-authorization effectiveness study to assess long-term outcomes of Nintedanib treatment in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) (Nintedanib long-term outcomes in patients with SSc)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106793
• EU PAS number:
  EUPAS106792
• Study ID:
  106793
• Official title and acronym:
  Non-interventional post-authorization effectiveness study to assess long-term outcomes of Nintedanib treatment in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) (Nintedanib long-term outcomes in patients with SSc)
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Armenia

  Austria

  Belgium

  Brazil

  Bulgaria

  Canada

  China

  Croatia

  Czechia

  Denmark

  Dominican Republic

  Egypt

  Estonia

  Finland

  France

  Germany

  Greece

  Hungary

  Iran, Islamic Republic of

  Ireland

  Israel

  Italy

  Japan

  Lithuania

  Malta

  Moldova, Republic of

  Montenegro

  Netherlands

  New Zealand

  Norway

  Poland

  Portugal

  Romania

  Russian Federation

  Serbia

  Slovenia

  South Africa

  Spain

  Sweden

  Switzerland

  Türkiye

  Ukraine

  United Kingdom

  United States
• Study description:
  The main objective of this post-authorization effectiveness study is to assess the long-term effectiveness of Ofev® on a composite outcome of time to forced vital capacity (FVC) decline, lung transplantation (indicating end-stage ILD), or mortality, in addition, to other outcomes of interest in patients with SSc-ILD using data from the EUSTAR registry. The primary study objectives will be to assess long-term treatment effectiveness of Ofev® based on a composite outcome of time to FVC decline, time to lung transplantation, or death. The secondary study objectives will be: - To assess long-term treatment effectiveness of Ofev® based on FVC decline, - To assess long-term treatment effectiveness of Ofev® based on time to lung transplantation (indicating end-stage ILD), - To assess long-term treatment effectiveness of Ofev® based on time to death, - To assess patterns of disease progression based on changes in FVC decline (overall and by treatment group) in patients with SSc-ILD, - To assess effects of other concomitant or previous therapies on a composite outcome of FVC decline, time to lung transplantation, or death (this does not correspond to an outcome but will be incorporated into the analyses), - To assess long-term effect of Ofev® on quality of life (QoL), - To assess the safety and effectiveness profile of Ofev® in the subset of patients with a diagnosis of pulmonary hypertension (PH) at baseline, and - To assess the incidence rates of 1) major bleeding (defined as requiring intervention or hospitalization), 2) gastrointestinal perforation, 3) thromboembolism (arterial or venous) by treatment group.
• Study status:
  Planned

Research institution and networks

Networks

Eustar – European Scleroderma Trials & Research Group

Study timelines

Date when funding contract was signed

Planned: 01/06/2023

Study start date

Planned: 01/08/2023

Data analysis start date

Planned: 01/08/2033

Date of interim report, if expected

Planned: 31/12/2025

Date of final study report

Planned: 31/12/2033

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer-Ingelheim

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable