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A Double Blind, Randomized, Placebo-Controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients with Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD) This study is in follow-up

General Information

Age Group

Adult

Status

Active

Protocol Number

1199.214

Offered At

Inova Heart and Vascular Institute
Advanced Lung Disease and Transplant Clinic
3300 Gallows Road
Falls Church, VA  22042

Principal Investigator

Oksana Shlobin, MD

Eligibility Information

  • Age > 18 years
  • Diagnosis of systemic sclerosis
  • Systemic sclerosis disease onset (defined by first non-Raynaud symptom) within 5 years
  • Systemic sclerosis related interstitial lung disease confirmed by HRCT; Extent of fibrotic disease in the lung > 10%
  • FVC > 40% of predicted normal
  • DLCO 30% to 89% of predicted normal

Ineligibility Information

  • Abnormal liver function panel results
  • Creatinine clearance <30 mL/min
  • Airway obstruction (pre-bronchodilator FEV1/FVC <0.7)
  • Other clinically significant pulmonary abnormalities
  • Significant pulmonary hypertension
  • Cardiovascular diseases
  • More than 3 digital fingertip 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, colchizine, D-penicillamine, sulfasalazine, cyclophosphamide, rituximab, tocilizumab, abatacept, leflunomide, tacrolimus, newer anti-arthritic treatments like tofacitinib and ciclosporine A, potassium para-aminobenzoate
  • Unstable background therapy with either mycophenolate mofetil or methotrexate
  • Previous or planned hematopoietic stem cell transplantation