Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT02597933
Eligibility Criteria:
Inclusion criteria:
* 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
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02597933
Study Brief:
Protocol Section:
NCT02597933