Health Condition 1: null- Systemic Sclerosis Associated Interstitial Lung Disease
Conditions
Interventions
Intervention1: Nintedanib
: Dose - 150 mg
Frequency - Twice daily
Route of adminstration - Oral
Total Duration - 52 weeks
Control Intervention1: mycophenolate mofetil: mycophenolate mofetil
Control
Sponsors
Boehringer Ingelheim India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent consistent with ICH-GCP guidelines and local laws signed prior to entry into the trial and any trial related procedures. 2. Patients must fulfil the 2013 ACR / EULAR classification criteria for SSc. 3. SSc disease onset (defined by first non-Raynaud symptom) must be within 5 years of Visit 1. 4. SSc related Interstitial Lung Disease pattern must be confirmed by HRCT performed within 12 months of Visit 2. The extent of fibrotic disease in the lung must be more than or equal to 10% on HRCT, assessed by central review. 5. FVC more than or equal to 40% of predicted normal at Visit 2. 6. DLCO (corrected for Hb [Visit 1]): 30% to 89% of predicted at Visit 2
Exclusion criteria
Exclusion criteria: 1. AST, ALT more than 1.5 x ULN. 2. Bilirubin more than 1.5 x ULN. 3. Creatinine clearance less than 30 mL/min calculated by Cockcroftâ??Gault formula 4. Airway obstruction (pre-bronchodilator FEV1/FVC less than 0.7) at Visit 1. 5. In the opinion of the Investigator, other clinically significant pulmonary abnormalities. 6. Significant PH 7. Cardiovascular diseases 8. More than 3 digital fingertip ulcers at Visit 2 or a history of severe digital necrosis requiring hospitalization. 9. Bleeding risk 10. History of thrombotic event (including stroke and transient ischemic attack) within 12 months of Visit 1. 11. Known hypersensitivity to the trial medication or its components (i.e. soya lecithin). 12. Other disease or conditions that may interfere with testing procedures 13. Life expectancy of less than 2.5 years for disease other than SSc in investigator assessment. 14. Patients with clinical signs of malabsorption or needing parenteral nutrition 15. Previous treatment with nintedanib or pirfenidone. 16. Other investigational therapy received within 1 month or 6 half-lives (whichever was greater) prior to screening Visit (Visit 1). 17. Treatment with a. Prednisone more than 10 mg/day or equivalent received within 2 weeks prior Visit 2, b. Azathioprine, hydroxychloroquine, colchizine, D-penicillamine, sulfasalazine, received within 8 weeks prior Visit 2, c. Cyclophosphamide, rituximab, tocilizumab, abatacept, leflunomide, tacrolimus, newer anti-arthritic treatments like tofacitinib and ciclosporine A, potassium paraaminobenzoate, received within 6 months prior Visit 2. 18. Unstable background therapy with either mycophenolate mofetil or methotrexate (combined therapy of both not allowed) 19. Previous hematopoietic stem cell transplantation (HSCT), or HSCT planned within the next year. 20. Major surgical procedures planned to occur during trial period. 21. Women who are pregnant, nursing, or who plan to become pregnant while in the trial. 22. Women of childbearing potential not willing or able to use highly effective methods of birth control. 23. In the opinion of the Investigator, active alcohol or drug abuse. 24. Patients not able to understand or follow trial procedures including completion of selfadministered questionnaires without help.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annual rate of decline in FVC in mL over 52 weeks.Timepoint: Annual rate of decline in FVC in mL over 52 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Absolute change from baseline in the modified Rodnan Skin Score (mRSS) at week 52. 2) Absolute change from baseline in SGRQ total score at Week 52.Timepoint: 52 weeks | — |
Countries
Australia, Belgium, Canada, China, Denmark, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom, United States of America
Contacts
Public ContactDr Partha Gokhale
Boehringer Ingelheim
Outcome results
None listed