Patients with Systemic Sclerosis and associated Interstitial Lung Disease MedDRA version: 19.1 Level: LLT Classification code 10012977 Term: Diffuse systemic sclerosis System Organ Class: 100000004859 MedDRA version: 19.1 Level: LLT Classification code 10036814 Term: Progressive systemic sclerosis System Organ Class: 100000004859 MedDRA version: 19.1 Level: PT Classification code 10042954 Term: Systemic sclerosis pulmonary System Organ Class: 10038738 - Respiratory, thoracic and mediastinal d
Conditions
Sponsors
Boehringer Ingelheim bv
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 450 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: - AST, ALT >1.5 x ULN - Bilirubin >1.5 x ULN - Creatinine clearance 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 - Patients with underlying chronic liver disease (Child Pugh A, B, C hepatic impairment) - Patients with a history of Scleroderma Renal Crisis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate a reduction in the annual rate of decline in FVC in mL over 52 weeks;Secondary Objective: To demonstrate efficacy in regard to skin fibrosis at week 52 and to demonstrate an improvement of patient's symptoms at week 52;Primary end point(s): 1: Annual rate of decline in FVC in mL ;Timepoint(s) of evaluation of this end point: 1: 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Absolute change from baseline in the mRSS 2: Absolute change from baseline in SGRQ total score 3: Annual rate of decline in FVC in percent predicted 4: Absolute change from baseline in FVC in mL 5: Relative change from baseline (%) of mRSS 6: Time to all-cause mortality 7: Absolute change from baseline at week 52 in CRISS index score 8: Absolute change from baseline in DLCO in percent predicted 9: Absolute change from baseline in digital ulcer net burden 10: Absolute change from baseline in HAQ-DI score 11: Absolute change from baseline in FACIT dyspnoea score ;Timepoint(s) of evaluation of this end point: 1: 52 weeks 2: 52 weeks 3: 52 weeks 4: 52 weeks 5: 52 weeks 6: 52 weeks 7: 52 weeks 8: 52 weeks 9: 52 weeks 10: 52 weeks 11: 52 weeks | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Thailand, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim
Outcome results
None listed