Principal Investigator: Mary  Scholand
Keywords: systemic sclerosis , pulmonary fibrosis , connective tissue disease , scleroderma , scleroderma ILD , ofev , nintedanib Department: Pulmonary
IRB Number: 00108763
Specialty: Pulmonary
Sub Specialties: Pulmonary Fibrosis
Recruitment Status: Active, not recruiting

Contact Information

Cassie Larsen
cassie.larsen@hsc.utah.edu
8015815811

Brief Summary

The primary objective of this trial is to assess the long-term safety of
nintedanib treatment in patients with Systemic Sclerosis associated
Interstitial Lung Disease who have completed (did not prematurely
discontinue trial medication) the phase III parent trial SENSCISTM
(1199.214).

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
nintedanib treatment initiation, during the trial and for 3 months after last intake of
nintedanib. A list of contraception methods meeting these criteria is provided in the
patient information.

Exclusion Criteria

1. AST, ALT > 3 x ULN
2. Bilirubin > 2 x ULN
3. Creatinine clearance <30 mL/min calculated by Cockcroft–Gault formula (Appendix
10.2).
4. Clinically relevant anaemia at investigators discretion.
5. Bleeding risk, any of the following
a. Known genetic predisposition to bleeding according to the judgement of the
investigator
b. Patients who require
i. Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K
antagonists, direct thrombin inhibitors, heparin, hirudin)
ii. High dose antiplatelet therapy.
[Note: Prophylactic low dose heparin or heparin flush as needed for
maintenance of an indwelling intravenous device (e.g. enoxaparin 4000
I.U. s. c. per day), as well as prophylactic use of antiplatelet therapy (e.g.
acetyl salicylic acid up to 325 mg/day, or clopidogrel at 75 mg/day, or
equivalent doses of other antiplatelet therapy) are not prohibited].
c. Hemorrhagic central nervous system (CNS) event after completion of the
parent trial SENSCISTM
d. Any of the following after last treatment of SENSCISTM:
i. Haemoptysis or haematuria

ii. Active gastro-intestinal bleeding or GI – ulcers
iii. Gastric antral vascular ectasia (GAVE)
iv. Major injury or surgery (investigators judgement).
e. 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.
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