A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis

Exclusion Criteria

• •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)