Systemic Sclerosis associated Interstitial Lung Disease MedDRA version: 21.0 Level: LLT Classification code 10012977 Term: Diffuse systemic sclerosis System Organ Class: 100000004859 MedDRA version: 21.0 Level: LLT Classification code 10036814 Term: Progressive systemic sclerosis System Organ Class: 100000004859 MedDRA version: 20.0 Level: PT Classification code 10042954 Term: Systemic sclerosis pulmonary System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA v
Conditions
Sponsors
Boehringer Ingelheim Portugal, Lda.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who completed the SENSCISTM trial per protocol and did not permanently discontinue blinded treatment 2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial 3. Women of childbearing potential1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly as well as one barrier method for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 350 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. AST, ALT > 3 x ULN 2. Bilirubin > 2 x ULN 3. Creatinine clearance 2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by >1.5 x ULN at Visit 1. 6. New major thrombo-embolic events developed after completion of the parent trial SENSCISTM : a. Stroke; b. Deep vein thrombosis; c. Pulmonary embolism; d. Myocardial infarction. 7. Major surgery (major according to the investigator’s assessment) performed within the next 3 months 8. Time period > 12 weeks between last drug intake in SENSCISTM and Visit 2 of this trial. 9. Usage of any investigational drug after completion of the parent trial SENSCISTM or planned usage of an investigational drug during the course of this trial. 10. A disease or condition which in the opinion of investigator may put the patient at risk because of participation in this trial (e.g. clinically relevant intestinal pseudoobstruction) or limit the patient’s ability to participate in this trial 11. Chronic alcohol or drug abuse or any condition that, in the investigator’s opinion, makes them an unreliable trial subject or unlikely to complete the trial 12. Known hypersensitivity to the trial medication or its components (i.e. soya lecithin). 13. Women who are pregnant, nursing, or who plan to become pregnant while in the trial 14. Previous enrolment in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).;Secondary Objective: Not applicable;Primary end point(s): 1) The primary endpoint is the incidence of overall adverse events over the course of this extension trial.;Timepoint(s) of evaluation of this end point: 1) up to 34 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) n/a;Timepoint(s) of evaluation of this end point: 1) n/a | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, 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 ContactCT Disclosure & Data Transparency
Boehringer Ingelheim International GmbH
Outcome results
None listed