Study tests, doctor visits, and the study drug will be provided at no cost to you. If you need additional medication to treat your systemic sclerosis, it will be prescribed by your study doctor in the normal way and will not be provided as part of the study.

The study site may help with travel arrangements or reimbursement for travel to and from the study site. Ask the study staff for more information.

The pharmaceutical company GSK is sponsoring the study. They provide the funds for the study doctor and study clinic to run this study. Doctors at research centers around the world have partnered with GSK to conduct this study.

If you are enrolled in the study, there will be at least 9 scheduled visits to the study clinic. There will be additional visits if screening takes longer than 1 visit or if you join the extension study.

A computer is used to assign participants to study treatment groups by chance, like dealing from a shuffled deck of cards. This is called randomization.

The placebo looks just like the study drug but has no active ingredients.

You have an equal chance of being placed in the active study drug group or the placebo group. 

Neither you, the study doctor, nor the person giving the injection will know whether you are getting the active study drug or placebo.

Although we cannot guarantee that you will benefit by taking part, the knowledge gained may help doctors and researchers learn more about systemic sclerosis and its treatment.

As with all medicines, there is a chance of side effects, which are unwanted and unintended effects from a medicine. Talk to the study doctor for more information on possible side effects. Your health will be closely monitored during the entire study. It is very important to tell the study doctor if you notice any changes in your health or if anything is bothering you.

You can leave the study at any time for any reason without giving any reason. Your choice will not change the quality of care you receive outside of this study.
If you decide to leave the study, you and the study doctor will discuss the best way to do this.