An Informed Consent document will be given to you before you join the study. This document outlines the key facts about the Pizzicato research study, including the risks and benefits of taking part, so you can consider what is involved, ask any questions and decide if you want to go ahead and sign the document. No study-related procedures will take place without a signed Informed Consent document.
A study investigator is a medical researcher in charge of conducting a clinical research study and ensuring the wellbeing of study volunteers. The investigators involved with the Pizzicato research study are all qualified licensed physicians and medical specialists.
An investigational medicine is a research study drug that has not yet been approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or similar agencies in other countries, for prescription by doctors.
You will be provided with packs or bottles of tablets for you take at home, once a day, except on the days when you have a study center visit, on those days you should take the pack/bottle with you and take your medication during your appointment.
Yes, you could be given a placebo. In the induction phase, there is a 1 in 3 chance of receiving placebo. Neither you nor your study doctor will know if you are given a placebo or active medicine. In the extension treatment period, everyone will receive active medicine.
You and your study doctor will know if you are randomly assigned to the PF-06651600 or PF-06700841 dosing arm, but you will not know if you are receiving placebo or active medicine during the dosing phase. You will know the active medicine you are given in the extension dosing phase.
PF-06651600 is an investigational drug. It is an oral medication.
PF-06700841 is an investigational drug. It is an oral medication.
At this stage, it will not be possible to continue with the investigational medicine. However, the aim of this clinical study is demonstrate the investigational medicine’s effectiveness in Crohn’s Disease, so if the results of the trial are encouraging it is possible that the investigational medication will be approved for general use with a prescription in the future.
There are risks associated with taking any medication and the investigational medication is no different in this respect. You may experience side effects or find that your symptoms are not improved or even increase in severity. It is important that you mention any concerns to your study doctor, as they will be able to give you more advice that is detailed.
We hope you will view taking part in this study as a positive experience and an opportunity to potentially improve the quality of life for millions of people living with Crohn’s Disease worldwide. You will receive study-related care at no cost and you will be closely monitored by a dedicated medical team for study-related purposes, during this study.
Of course we hope that you won’t want to, but you are completely free to leave the study at any time without giving a reason. The decision to leave the study will not affect your future medical care by your physician in any way.
Information about your personal health will be kept private and confidential. With your permission, the information you provide via the pre-screening form on this website about your medical history and health condition will be transferred to the Pizzicato study team. A representative from the study team will contact you to further determine your interest and eligibility. Your personal information will not be disclosed to anyone outside of this clinical research study group without your consent unless disclosure is required by law or regulations of the FDA, EMA, or similar agencies in other countries.