Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age \>= 18 years
2013 American College of Rheumatology (ACR) / EULAR classification criteria for SSc fulfilled
SSc disease onset (defined by first non-Raynaud symptom) within 7 years
SSc related Interstitial Lung Disease confirmed by High Resolution Computer Tomography (HRCT); Extent of fibrotic disease in the lung \>= 10%
FVC \>= 40% of predicted normal
Carbon Monoxide Diffusion Capacity (DLCO) 30% to 89% of predicted normal
You may not be if
Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) \>1.5 x ULN
Bilirubin \>1.5 x ULN
Creatinine clearance \<30 mL/min
Airway obstruction (pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1)/FVC \<0.7)
Other clinically significant pulmonary abnormalities
Significant Pulmonary Hypertension (PH)
Cardiovascular diseases
More than 3 digital fingertip ulcers or a history of severe digital necrosis requiring hospitalization or severe other ulcers
Bleeding risk (such as predisposition to bleeding, fibrinolysis, full-dose anticoagulation, high dose antiplatelet therapy, history of hemorrhagic central nervous system (CNS) event within last year
international normalised ratio (INR) \>2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by \>1.5 x ULN)
History of thrombotic event within last year
Clinical signs of malabsorption or needing parenteral nutrition
Previous treatment with nintedanib or pirfenidone
Treatment with prednisone \>10 mg/day, azathioprine, hydroxychloroquine, colchicine, D-penicillamine, sulfasalazine, cyclophosphamide, rituximab, tocilizumab, abatacept, leflunomide, tacrolimus, newer anti-arthritic treatments like tofacitinib and cyclosporine A, potassium para-aminobenzoate
Unstable background therapy with either mycophenolate mofetil or methotrexate
Previous or planned hematopoietic stem cell transplantation
Patients with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment)
Clareo Health | A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis
