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CTRI Number  CTRI/2018/03/012529 [Registered on: 13/03/2018] Trial Registered Prospectively
Last Modified On: 13/03/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   A study to review the safety of long term treatment with nintedanib in patients with scleroderma related lung fibrosis. 
Scientific Title of Study   An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD) 
Trial Acronym  SENSCISTM- ON (Extension) 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sumedh Bondal 
Designation  Project Manager 
Affiliation  Boehringer Ingelheim India Pvt Ltd. 
Address  Boehringer Ingelheim India Pvt Ltd. 1102, 11th Floor, Hallmark Business Plaza, Near Gurunanak Hospital, Gurunanak Hospital Road, Bandra East Mumbai MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
400051
India 
Phone  912226456477  
Fax  912226456163  
Email  sumedh.bondal@boehringer-ingelheim.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Partha Gokhale 
Designation  Head Clinical Operations 
Affiliation  Boehringer Ingelheim India Pvt Ltd. 
Address  Boehringer Ingelheim India Pvt Ltd. 1102, 11th Floor, Hallmark Business Plaza, Near Gurunanak Hospital, Gurunanak Hospital Road, Bandra East Mumbai MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
400051
India 
Phone  912226456477  
Fax  912226456163  
Email  partha.gokhale@boehringer-ingelheim.com  
 
Details of Contact Person
Public Query  
Name  Dr Partha Gokhale 
Designation  Head Clinical Operations 
Affiliation  Boehringer Ingelheim India Pvt Ltd. 
Address  Boehringer Ingelheim India Pvt Ltd. 1102, 11th Floor, Hallmark Business Plaza, Near Gurunanak Hospital, Gurunanak Hospital Road, Bandra East Mumbai MAHARASHTRA 400051 India

Mumbai
MAHARASHTRA
400051
India 
Phone  912226456477  
Fax  912226456163  
Email  partha.gokhale@boehringer-ingelheim.com  
 
Source of Monetary or Material Support  
Boehringer Ingelheim India Pvt Ltd, 1102, Hallmark Business Plaza, Near Gurunanak Hospital, Gurunanak Hospital Road, Bandra (E), Mumbai 400051 
 
Primary Sponsor  
Name  Boehringer Ingelheim India Pvt Ltd 
Address  1102, Hallmark Business Plaza, Near Gurunanak Hospital, Gurunanak Hospital Road, Bandra (E), Mumbai 400051 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Canada
Chile
China
Czech Republic
Argentina
Australia
Austria
Belgium
Brazil
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 of America  
Sites of Study  
No of Sites = 9  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Uma Kumar  All India Institute of Medical Sciences (AIIMS)  Department of Rheumatology, Room No 4076, Teaching Block 4th Floor AIIMS, Ansari Nagar, New Delhi - 110029
New Delhi
DELHI 		 00911126588663

umaakumar@yahoo.co.in 
Dr Ashish Kumar  Asthma Bhawan  Room Number 02, R-3, sector-6, Vidhyadhar Nagar, Jaipur - 302039
Jaipur
RAJASTHAN 		 00911412235005

drashish19@gmail.com 
Dr Rahul Lokhande  B.J. Medical College and Sasoon General Hospital  Department of Pulmonary Medicine. Chest OPD, Room No. 21, Somwar Peth, Pune - 411001
Pune
MAHARASHTRA 		 009102026128000

drrahul_2007@yahoo.com 
Dr Jugal Kishore Kadel  Care Hospital  OPD Room No. 238, Banjara Hills,Road No 10, Hyderabad - 500034
Hyderabad
ANDHRA PRADESH 		 00914030417777

jkishorek71@yahoo.co.in 
Dr Rajesh Swarnakar  Getwell Hospital & Research Institute  Department of Pulmonology & Respiratory Medicine, 20/1,Khare Marg, Dhantoli, Nagpur - 440012.
Nagpur
MAHARASHTRA 		 00917126632203

drrajeshswarnakar@gmail.com 
Dr Gayathri Devi HJ  M. S. Ramaiah Medical College and Hospitals  Department of Pulmonary Medicine, Gnanagangothri Campus, Gate-4, New BEL Road, MSRIT Post, Bangalore - 560054
Bangalore
KARNATAKA 		 00918022183023

gayathrijoshy@gmail.com 
Dr Phani Kumar  Nizams Institute of Medical Sciences  4th Floor, Millenium Block, Dept. of Rheumatology, Punjagutta, Hyderabad – 500082
Hyderabad
ANDHRA PRADESH 		 00914023489405

dphani.mbbs@gmail.com 
Dr Digambar Behera  Postgraduate Institute of Medical Education and Research, Chandigarh (PGIMER)  Department of Pulmonary Medicine, 4th Floor F-block Room No 11 Nehru Building, Sector 12 , PGIMER, Chandigarh - 160012
Chandigarh
CHANDIGARH 		 00911722756822

dirlrsi@gmail.com 
Dr Ujjawal Parakh  Sir Gangaram Hospital  Room No. G7, Sir Gangaram Hospital Marg, Rajinder Nagar New Delhi - 110060
New Delhi
DELHI 		 00911125861001

ujjwalparakh@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Ethics Committee, M. S. Ramaiah Medical College and Hospitals  Approved 
Getwell Institutional Ethics Committee  Approved 
Institutional Ethics Committee, All India Institute of Medical Sciences (AIIMS)  Submittted/Under Review 
Institutional Ethics Committee, Asthma Bhawan  Approved 
Institutional Ethics Committee, B. J. Medical College and Sassoon General Hospitals  Submittted/Under Review 
Institutional Ethics Committee, Care Foundation  Approved 
Institutional Ethics Committee, Nizam’s Institute of Medical Sciences  Submittted/Under Review 
Institutional Ethics Committee, Post Graduate Institute of Medical Education And Research (PGIMER)  Submittted/Under Review 
Sir Gangaram Hospital Ethics Committee  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nintedanib  1 x 150mg capsule b.i.d. (total daily dose 300mg). 1x 100mg capsule b.i.d. (total daily dose 200mg). 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  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 potential 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. 
 
ExclusionCriteria 
Details  1. AST, ALT > 3 x ULN
2. Bilirubin > 2 x ULN
3. Creatinine clearance <30 mL/min
4. Clinically relevant anaemia at investigators discretion.
5. Bleeding risk, like
a. Known genetic predisposition to bleeding as per investigator
b. Patients who require
-Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vit K
antagonists,DTI, heparin, hirudin)
-High dose antiplatelet therapy.
-Hemorrhagic CNS event after completion of main study
6.Any of the following after last treatment of the parent trial
-Haemoptysis or haematuria
-Active GI bleeding or GI – ulcers
-Major injury or surgery (PI judgement)
7.Coagulation parameters: INR >2, prolongation of PT & PTT by >1.5 x ULN at Visit 1
8. New major thrombo-embolic events developed after completion of the parent trial:
-Stroke
-DVT
-PE
-MI
9.Major injury or surgery (major according to the investigator’s assessment) done within the next 3 months
10. Time period > 12 weeks between last drug intake of the parent trial SENSCISTM & randomization visit of this study
11. A disease or condition which in the opinion of investigator may put the patient at risk.


 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary endpoint is the incidence (number and % of patients) of overall adverse events
over the course of this extension trial. 		 Endpoint Assessment through out the course of the study. Final Assessment at the end of the study. 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="25" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/08/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/12/2017 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   No trial results should be published prior to finalisation of the clinical trial report and approval from Sponsor 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
This is an open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD).


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).
 
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