A study to review the safety of long term treatment with nintedanib in patients with scleroderma related lung fibrosis.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2018/03/012529
• Date of registration: 13-03-2018
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim India Pvt Ltd
• Public title: A study to review the safety of long term treatment with nintedanib in patients with scleroderma related lung fibrosis.
• Scientific title: An open-label extension trial to assess the long term safety of nintedanib in patients with â??Systemic Sclerosis associated Interstitial Lung Diseaseâ?? (SSc-ILD) - SENSCISTM- ON (Extension)
• Date of first enrolment: 01-08-2018
• Target sample size: 400
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=22543
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, 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 of America

Contacts

• Name: Dr Partha Gokhale
• Affiliation: Boehringer Ingelheim India Pvt Ltd.

• Name: Dr Partha Gokhale
• Affiliation: Boehringer Ingelheim India Pvt Ltd.

Key inclusion & exclusion 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 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.
Exclusion criteria: 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 â?? 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 investigatorâ??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.







Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD)

Intervention(s)

Intervention1: Nintedanib: 1 x 150mg capsule b.i.d. (total daily dose 300mg).
1x 100mg capsule b.i.d.
(total daily dose 200mg).
Control Intervention1: Not Applicable: Not Applicable

Primary Outcome(s)

The primary endpoint is the incidence (number and % of patients) of overall adverse events

over the course of this extension trial.Timepoint: Endpoint Assessment through out the course of the study. Final Assessment at the end of the study.

Secondary Outcome(s)

Not ApplicableTimepoint: Not Applicable

Secondary ID(s)

NIL

Source(s) of Monetary Support

Boehringer Ingelheim India Pvt Ltd, 1102, Hallmark Business Plaza, Near Gurunanak Hospital, Gurunanak Hospital Road, Bandra (E), Mumbai 400051

Ethics review

Status: Approved
Approval date: 20/11/2017
Contact:

Getwell Institutional Ethics Committee

Status: Approved
Approval date: 23/12/2017
Contact:

Ethics Committee, M. S. Ramaiah Medical College and Hospitals

Status: Approved
Approval date: 29/12/2017
Contact:

Institutional Ethics Committee, Asthma Bhawan

Status: Approved
Approval date: 13/01/2018
Contact:

Institutional Ethics Committee, Care Foundation

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, All India Institute of Medical Sciences (AIIMS)

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, B. J. Medical College and Sassoon General Hospitals

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, Nizamâ??s Institute of Medical Sciences

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, Post Graduate Institute of Medical Education And Research (PGIMER)

Status: Not Approved
Approval date:
Contact:

Sir Gangaram Hospital Ethics Committee