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Clin Exp Rheumatol. 2017 Sep-Oct;35 Suppl 106(4):75-81. Epub 2017 Jun 29.

Design of a randomised, placebo-controlled clinical trial of nintedanib in patients with systemic sclerosis-associated interstitial lung disease (SENSCIS™).

Author information

1
University Hospital Zurich, Switzerland. oliver.distler@usz.ch.
2
National Jewish Health, Denver, Colorado, USA.
3
University of Erlangen-Nuremberg, Erlangen, Germany.
4
University of Texas Houston Medical School, Houston, Texas, USA.
5
NIHR Biomedical Research Unit Royal Brompton Hospital, London, UK and Fibrosis Research Group, National Heart and Lung Institute, Imperial College London, UK.
6
Louis Pradel Hospital, Claude Bernard University Lyon 1, Lyon, France.
7
Feinberg School of Medicine, Chicago, Illinois, USA.
8
SCS Boehringer Ingelheim Comm.V., Brussels, Belgium.
9
Boehringer Ingelheim (Schweiz) GmbH, Basel, Switzerland.
10
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.
11
Cleveland Clinic, Cleveland, Ohio, USA.

Abstract

OBJECTIVES:

Nintedanib is a tyrosine kinase inhibitor approved for the treatment of idiopathic pulmonary fibrosis (IPF). The pathological pathways involved in fibrogenesis in IPF and interstitial lung disease associated with systemic sclerosis (SSc-ILD) show commonalities; both involve fibroblast activation, myofibroblast accumulation and deposition of extracellular matrix. The SENSCIS™ trial is a randomised, placebo-controlled Phase III trial that will evaluate the efficacy and safety of nintedanib in patients with SSc-ILD (NCT02597933).

METHODS:

Approximately 520 patients with SSc (based on 2013 American College of Rheumatology/European League Against Rheumatism criteria) and ILD (≥10% fibrosis of the lungs, confirmed by central assessment of chest high resolution computed tomography), forced vital capacity (FVC) ≥40% predicted and diffusing capacity for carbon monoxide of 30-89% predicted will be enrolled. Patients will be randomised (1:1) to nintedanib 150 mg twice daily or placebo, stratified by the presence of anti-topoisomerase I antibody. To reflect real-world management, patients receiving prednisone (≤10 mg/day) and/or a stable dose of mycophenolate or methotrexate, will be eligible. The primary endpoint is the annual rate of decline in FVC (mL/ year) assessed over 52 weeks. Patients will remain on blinded study treatment until the last patient completes 52 weeks of treatment or for a maximum of 100 weeks of treatment. Key secondary endpoints are absolute changes from baseline in modified Rodnan skin score and St George's Respiratory Questionnaire at week 52.

RESULTS:

Recruitment for the trial began in November 2015.

CONCLUSIONS:

This trial will assess the efficacy and safety of nintedanib in patients with SSc-ILD.

PMID:
28664834
[Indexed for MEDLINE]
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