A double blind, randomised, 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)
- Conditions
- scar formation in the lungs caused by systemic sclerosissystemic sclerosis associated lung fibrosis1002496710011063
- Registration Number
- NL-OMON47379
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 17
- Age ><= 18 years
- 2013 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 HRCT; Extent of
fibrotic disease in the lung ><= 10%
- FVC ><= 40% of predicted normal
- DLCO 30% to 89% of predicted normal
- AST, ALT > 1.5 x ULN;- Bilirubin > 1.5 x ULN;- 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, or a history of severe digital necrosis requiring hospitalization or severe other ulcers at discretion of the investigator.;- 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;- Known hypersensitivity to the trial medication or its components (i.e. soya lecithin);- 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;- Patients with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment);- Patient with a history of Scleroderma renal crisis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>to demonstrate a reduction in the annual rate of decline in FVC in<br /><br>mL over 52 weeks in the nintedanib treatment group compared to the placebo<br /><br>group</p><br>
- Secondary Outcome Measures
Name Time Method <p>The main secondary objectives are to demonstrate efficacy in regard to skin<br /><br>fibrosis as<br /><br>assessed by the modified Rodnan Skin Score at week 52 and to demonstrate an<br /><br>improvement<br /><br>of patient*s symptoms as measured by the SGRQ (Saint George*s Respiratory<br /><br>Questionnaire)<br /><br>total score at week 52.<br /><br>Other objectives are to assess safety and tolerability, mortality, the effects<br /><br>on different<br /><br>systemic organ manifestations of SSc, pharmacokinetics and the effects of<br /><br>nintedanib on<br /><br>patient*s perception of his/her disease.</p><br>