The CHERISH Study
About the CHERISH study
CHERISH is a clinical research study conducted by UCB Biopharma SPRL, for pregnant women who are receiving certolizumab pegol (Cimzia®) to treat a chronic inflammatory condition. The purpose of the CHERISH study is to measure changes in plasma levels of Cimzia® over the course of pregnancy and after delivery.
What can I expect if I want to join the CHERISH study?
The study doctor or staff will explain all the details of the study, including the risks and benefits, and will answer your questions. If you wish to participate, you will sign an informed consent form to ensure that you understand the study and agree to participate.
This study mainly involves some blood tests. You will continue to take your medications as prescribed by your own doctor.
The study will consist of:
- A screening visit at the clinic. This will take place within the first 10 weeks of your pregnancy. At this visit, you will answer questions about your pregnancy and health and undergo a brief medical examination to determine if you are a good match for continuing in the study.
- Sampling visits during and after your pregnancy. A study staff member will draw your blood during regularly scheduled home health nursing visits, or at visits to the study site or a health care facility. You will have blood draws before approximately six of your Cimzia® doses and after three of your Cimzia® doses during your pregnancy. You will also have a pre-dose blood draw about 8 - 12 weeks after your delivery and, if possible, a post-dose blood draw about one week after you take your Cimzia® dose.
- A safety follow-up by phone. About five weeks after your last study visit, the study doctor or staff will call you to ask about your medications and any side effects.
How long will the study last?
The duration of the study will depend on your stage of pregnancy at enrollment but is planned to last up to a maximum of 48-53 weeks.
Is there any cost to participate?
There is no cost for study-related medical assessments. You will continue to obtain your own supply of Cimzia® throughout the study.
What are my responsibilities during the study?
You will be expected to follow the instructions of the study doctor and study staff and have the required blood sampling. You will use an electronic device (e-diary) to record all Cimzia® dosing dates and times. You will also keep notes of any other treatments that you receive, including over-the-counter products and supplements. About five weeks after your final study visit, you will participate in a follow-up telephone call. During the course of the study, you will be responsible for obtaining and administering your own supply of commercially available Cimzia® under the care of your physician.
What are the risks of participating in this study?
You may experience minor discomfort or reactions at the site where the blood samples are drawn. The study doctor will explain all the details of the study, including any risks, during the informed consent process and will address any questions you may have.
What are the benefits of participating in this study?
Although you will not personally benefit from your participation in this study, you will help provide new information that may benefit other pregnant women who have an inflammatory disease in the future. The information learned from this study will lead toward a better understanding how Cimzia® works during pregnancy.