WHAT IS THE MAIN PURPOSE OF THE STUDY?
The main purpose of the study is to compare the effects of an investigational drug (study drug) to placebo and to determine the best dose of the study drug for treating Crohn’s disease.
WHAT IS THE STUDY DRUG AND HOW DOES IT WORK?
The study drug is a type of drug called an antibody. The study drug stops how interleukin-6 (IL-6), a protein that stimulates the immune system, works in the body. Many people with Crohn’s disease have higher levels of IL-6. This may play a role in the signs and symptoms of their disease, particularly inﬂammation of the gastrointestinal tract.
This study drug, PF-04236921, is designed to ﬁght inﬂammation by working directly on the immune system.
HOW DO I KNOW IF I’M ELIGIBLE TO PARTICIPATE?
You may be eligible to participate in the ANDANTE study if you:
- Are between 18 and 75 years old
- Have active Crohn’s disease
- Have failed to respond to anti-TNF treatments (e.g., inﬂiximab (Remicade), adalimumab (Humira), certolizumab pegol (Cimzia)
Complete eligibility criteria can be found online at www.paceresearch.com/crohns and should be reviewed and discussed with your doctor.
WHAT CAN I EXPECT IF I PARTICIPATE?
If you choose to participate, you will be asked to:
- Sign an informed consent form before beginning any study-related activities
- Attend up to 17 study visits for up to 11 months
- Complete questions daily, for 4 months, about your well being on a handheld electronic device
- Keep a daily paper diary to record the use of oral steroids, ibuprofen, and medicines you take for diarrhea
- Provide stool samples
- Have a colonoscopy and other study-related exams and procedures
You will have a 67 percent (2 in 3) chance of receiving the study drug and a 33 percent (1 in 3) chance of receiving placebo. You will receive your dose of study drug or placebo as an under the skin injection on the 2nd and 3rd visit.
Your participation is voluntary and you may leave the study at any time. You may be reimbursed for clinical study-related expenses, such as your time and travel.
WHY PARTICIPATE IN THE STUDY?
By participating in the ANDANTE study, you are playing a more active role in your own health care. Your participation may help doctors ﬁnd ways to treat Crohn’s disease and get new treatments for others in the future.
Choosing to participate in the study is an important personal decision. Take as much time as you need to talk with family and friends, your doctor or other health care professional, the study doctor, and/or study site staﬀ before making a decision.