Institutional Review Board, Hospital for Special Surgery
October 06, 2016
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
In this study, patients diagnosed with Systemic Sclerosis (SSc) associated Interstitial Lung Disease based upon classification according to the most recent ACR/EULAR criteria and HRCT (within previous 12 months) will be treated in a randomized, double-blinded, 1:1 fashion with Nintedanib 150 mg BID or with placebo. The purpose of this study is to investigate how well the treatment with the study drug nintedanib can demonstrate a slowing of the rate of lung scarring, how well the study treatment has an effect on the skin thickening, and evaluate how patients feel about their condition while on placebo or nintedanib. The duration of study treatment is 52 weeks with the option of continuation of blinded treatment to a maximum of 100 weeks. The primary endpoint of the study, measured at week 52 is the rate of decline in FVC in mL over 52 weeks. After the screening visit, the study requires 9 to 12 follow up visits. Visits 2 to 5 are 2 weeks apart, weeks 6 to 9 are 6 weeks apart, and visits 9 to 12 are 16 weeks apart. An estimated 520 subjects are expected to participate worldwide. It is expected that 3 patients will be enrolled at this site.
Bilirubin > 1.5 x ULN Creatine clearance <30 mL/min