Summary:
Treating your Crohn’s disease doesn’t have to be a solo act.
About the studies
We know that having active Crohn’s disease can be painful and frustrating, especially if you’ve been unresponsive to anti-TNF (tumor necrosis factor) medications. OPERA and ANDANTE are two clinical research studies that are bringing together hundreds of people like you to evaluate medications in development (study drugs) that are intended to reduce the symptoms of Crohn’s disease, particularly those related to inflammation of the gastrointestinal tract.
The OPERA and ANDANTE studies are two Phase 2 clinical research studies for adults with active Crohn’s disease. The main purpose of each of these studies is to evaluate the safety and effectiveness of a study drug. Several hundred adults in the United States and other countries are expected to participate in these studies.
About the study drug
The OPERA study drug (PF-00547659) and the ANDANTE study drug (PF-04236921) are both man-made antibodies. Although both study drugs are intended to reduce the symptoms of Crohn’s disease, particularly those related to inflammation of the gastrointestinal tract, they do so by targeting different mechanisms of the disease process.
Who can participate?
You may be eligible to participate in the OPERA or ANDANTE clinical research study if you:
- Are between 18 and 75 years old
- Have active Crohn’s disease
- Have failed to respond or are intolerant to:
- Immunosuppressants (e.g., methotrexate, azathioprine, 6-mercaptopurine) And/or
- Anti-TNF treatments (e.g., Remicade® [infliximab], Humira® [adalimumab], Cimzia® [certolizumab pegol])
There are other eligibility requirements that the study doctor can review with you if you are interested in participating in one of these clinical research studies.
What does the study involve?
If you choose to participate, you will be asked to:
- Sign an informed consent document before beginning any study-related activities
- Attend up to 20 study visits for up to 28 months
- Complete questions daily for 3 months about your well-being on a handheld device
- Keep a daily paper diary to record the use of any steroids and medicines you take for diarrhea
- Provide stool samples
- Have a colonoscopy and other study-related exams and procedures
- Participants will receive 1 of 3 different doses of a study drug or a placebo, which looks like the study drug but does not contain any active medication. There is a 75 percent (3 in 4) chance that participants will receive a study drug and a 25 percent (1 in 4) chance of receiving a placebo
You may or may not benefit from participating in these studies. Your participation will allow the study sponsor to investigate alternative treatment options that may benefit others with Crohn’s disease in the future.
