An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)
An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)
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).
Inclusion Criteria:
Exclusion Criteria:
Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) > 3 x Upper Limit of Normal (ULN)
Bilirubin > 2 x ULN
Creatinine clearance <30 mL/min calculated by Cockcroft-Gault formula.
Clinically relevant anaemia at investigators discretion.
Bleeding risk, any of the following
Known genetic predisposition to bleeding according to the judgement of the investigator
Patients who require
Hemorrhagic central nervous system (CNS) event after completion of the parent trial 1199.214/1199-0340
Any of the following after last treatment of 1199.214/1199-0340:
Coagulation parameters: International normalised ratio (INR) >2, prolongation of prothrombin time (PT) and partial thromboplastin time (PTT) by >1.5 x ULN at Visit 1.
New major thrombo-embolic events developed after completion of the parent trial 1199.214/1199-0340:
Major surgery performed within the next 3 months
Time period > 12 weeks between last drug intake in 1199.214 or > 1 week between last nintedanib intake in trial 1199-0340 and Visit 2 of this trial
Usage of any investigational drug after completion of 1199.214/1199-0340 or planned usage of an investigational drug during the course of this trial.
A disease or condition which 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
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
Known hypersensitivity to the trial medication or its components (i.e. soya lecithin).
Women who are pregnant, nursing, or who plan to become pregnant while in the trial
Previous enrolment in this trial
Further exclusion criteria apply
New York, New York 10032, United States
Nashville, Tennessee 37204, United States
Ciudad Autonoma Buenos Aires, C1046AAQ, Argentina
Aichi, Seto, 489-8642, Japan
Fukuoka, Kurume, 830-0011, Japan
Hyogo, Himeji, 670-8520, Japan
Kanagawa, Kawasaki, 216-8511, Japan
Kanagawa, Sagamihara, 252-0375, Japan
Kanagawa, Yokohama, 236-0051, Japan
Nagasaki, Nagasaki, 852-8501, Japan
Osaka, Osakasayama, 589-8511, Japan
Osaka, Sakai, 591-8555, Japan
Osaka, Takatsuki, 569-8686, Japan
Shizuoka, Hamamatsu, 431-3192, Japan
Tokushima, Tokushima, 770-8503, Japan
Tokyo, Bunkyo-Ku, 113-8431, Japan
Tokyo, Bunkyo-Ku, 113-8603, Japan
Tokyo, Ota-ku, 143-8541, Japan
Georgetown Pulau Pinang, 10990, Malaysia
Muang, 40002, Thailand