APPROVED
AS MODIFIED
Mar 28, 2013
WIRBâ
SL0012
UCB, Inc., Smyrna, Georgia, United States
SL0012
20111247
W110728004
Research subject information and Consent formTITLE: / A PHASE 3, MULTICENTER, OPEN-LABEL, EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF EPRATUZUMAB TREATMENT IN SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS (EMBODY 4)
This consent form contains important information to help you decide whether to participate in a research study.
The study staff will explain this study to you. Ask questions about anything that is not clear at any time. You may take home an unsigned copy of this consent form to think about and discuss with family or friends.
Ø Being in a study is voluntary – your choice.
Ø If you join this study, you can still stop at any time.
Ø No one can promise that a study will help you.
Ø Do not join this study unless all of your questions are answered.
After reading and discussing the information in this consent form you should know:
· Why this research study is being done;
· What will happen during the study;
· Any possible benefits to you;
· The possible risks to you;
· Other options you could choose instead of being in this study;
· How your personal health information will be treated during the study and after the study is over;
· Whether being in this study could involve any cost to you; and
· What to do if you have problems or questions about this study.
Please read this consent form carefully.
RESEARCH SUBJECT INFORMATION AND CONSENT FORM
Title: A PHASE 3, MULTICENTER, OPEN-LABEL, EXTENSION STUDY TO ASSESS THE SAFETY AND TOLERABILITY OF EPRATUZUMAB TREATMENT IN SYSTEMIC LUPUS ERYTHEMATOSUS SUBJECTS (EMBODY 4)
Protocol No.: SL0012
WIRB® Protocol #20111247
W110728004
Sponsor: UCB, Inc.
Investigator: W. Winn Chatham, M.D.
SRC 076
1717 6th Ave South
Birmingham, Alabama 35294
United States
Site(s): University of Alabama at Birmingham
SRC 076
1717 6th Avenue South
Birmingham, Alabama 35294
United States
STUDY-RELATED
PHONE NUMBER(S): W. Winn Chatham, M.D.
866-876-2247
205-934-3411 (24 hour pager)
You have been asked to take part in a clinical research study initiated, managed, and financed by UCB Inc., the Sponsor of this study.
Before agreeing to participate in this study, you need to understand why the research is being done and what it will involve. This consent form describes the purpose, procedures, potential benefits, risks, discomforts, and precautions of the study. Please read each page of this consent form so that you can make an informed decision about your participation and ask your study doctor or the study staff to explain any words, terms or information that you do not clearly understand. Please discuss any questions you may have with the study doctor or study staff.
Once you understand the information, you must sign this consent form if you want to take part in the study. Study related procedures cannot be performed if your signature is not received. If you choose to take part in this study, a copy of the signed and dated consent form will be given to you.
Please give an accurate account of your health history to your study doctor. If you are not completely truthful with your study doctor regarding your health history, you may harm yourself by participating in this study.
If you have a personal or primary care doctor, we ask that you inform him/her if you decide to participate in this study.
PURPOSE OF THE STUDY
The purpose of this study is to assess the safety and tolerability of long-term epratuzumab treatment in subjects with lupus. Epratuzumab is an investigational (new) drug that has not yet been approved by the United States Food and Drug Administration (FDA) or any European Medicines Agencies.
To find out if epratuzumab will help or continue to help in reducing the symptoms in lupus patients, all subjects participating in this study will be assigned to one of the following treatment groups:
· 600 milligrams (mg) of epratuzumab weekly for a total of 4 weeks (total dose of 2400mg) over eight 12-week treatment cycles.
· 1200 milligrams (mg) of epratuzumab twice in 4 weeks (every other week for a total dose of 2400mg) over eight 12-week treatment cycles.
This means that during the course of the study you can be treated with epratuzumab up to 16 times if you are in the 1200mg group or 32times if you are in the 600mg group.
Whether you are assigned to the 600mg treatment group of epratuzumab or the 1200mg treatment group of epratuzumab will be determined at random (like flipping a coin). This will be automatically determined by a computer system. You have a 1 out of 2 or a 50% chance of being assigned to the 600mg treatment group and a 1 out of 2 or 50% chance of being assigned to the 1200mg treatment group.
Epratuzumab will be given to you by slow intravenous infusion. This means that a needle will be inserted into a vein in your arm. The needle will then be attached to a plastic tube and plastic bag containing epratuzumab. The contents (epratuzumab) of the plastic bag will then drip through the plastic tube and into the needle in your arm. Each infusion will last about 1 hour.
In order to try to minimize possible reactions to the infusion with the study drug, it is recommended that acetaminophen (a pain reliever) and diphenhydramine (an antihistamine given to prevent and/or treat allergic reactions) are administered to you prior to receiving each infusion. If your study doctor determines that it is in your best interest not to use diphenhydramine, an alternate antihistamine will be given to you prior to receiving study drug (epratuzumab).
During the study, it is allowed to a certain extent to treat your lupus symptoms with drugs other than the study drug or to continue ongoing treatment with such drugs. However, additional treatment with these drugs is only allowed up to certain doses. If you wish to know more about these dose allowances, please ask your study doctor.
Approximately 1400 subjects with lupus will be treated with study drug, in up to 300 study sites in approximately 30 countries.
DESCRIPTION OF THE STUDY
You are being asked to take part in this study because you participated in a previous double-blind study (either SL0009 or SL0010) or a previous open-label extension study (either SL0006 or SL0008) and the study doctor feels that you are an appropriate subject for this study. The goal of this clinical research study is to assess the safety and tolerability (to take with no bad effect) of the long-term treatment of epratuzumab, an investigational (new) drug, in reducing signs and symptoms of lupus. Lupus is an autoimmune disease, which is an illness that occurs when the body tissues are attacked by its own immune system (the system that protects against foreign substances in the body). It can affect various parts of the body such as the kidneys, heart, lungs and brain. Symptoms may include extreme fatigue, joint and muscle pain, eye problems, depression, mouth ulcers, facial or other rashes, hair loss and anemia (lack of healthy red blood cells).
The immune system in people with lupus cannot tell the difference between foreign substances and the body’s own cells and tissues. In lupus, the immune system makes antibodies (proteins that detect and destroy foreign substances in the body), and these antibodies then fight against the body’s cells and tissues, causing inflammation. Inflammation may include pain, heat, redness, swelling and loss of function and can be on the inside and/or the outside of the body.
Inflammation is considered the primary feature of lupus. Epratuzumab is believed to work, in part, by changing how B-cells (a type of white blood cell that produces antibodies, which detect and destroy foreign substances in the body) work and/or by reducing their number in the body, which may prevent the immune system from attacking healthy organs and thus reduce the level of inflammation.
For most people, lupus is a mild disease affecting only a few organs. For others, it may cause serious and even life-threatening problems. More than 90 percent of people with lupus are women. Symptoms and diagnosis occur most often when women are in their child-bearing years, between the ages of 15 and 45. Worldwide, conservative estimates are that over 5 million people have lupus.
Epratuzumab has been administered in 18 sponsored clinical studies to date; 8 studies in oncology (cancer) indications and 10 studies in autoimmune diseases (7 of these studies were specifically for the treatment of systemic lupus erythematosus, including the SL0006, SL0008, SL0009 and SL0010 studies).
PROCEDURES
If you agree to participate in this study, your involvement could last approximately 100 weeks or about 2 years and could involve up to 42 visits to your study doctor's office or clinic. The total number of your visits to the clinic will depend on which treatment group you are in and how long you stay in the study.
You will be asked to attend your study doctor’s office or clinic at the study entry visit (Visit 1). During this visit, your eligibility for enrollment into SL0012 will be determined. The results from the procedures performed at the End of Treatment Visit or the Early Withdrawal Visit in SL0009 or SL0010 may be used, if performed within 4 weeks of Visit 1 in SL0012. The procedures include the collection of blood samples, questionnaires that you are asked to complete, and lupus assessments performed by your study doctor. All subjects completing studies SL0006 or SL0008 must complete all Visit 1 assessments in SL0012.
If you qualify to enroll in SL0012, you will be assigned to one of the two treatment groups and you will be given treatment at Visit 1.
· If you are assigned to the 600mg treatment group, you will come into the study doctor's office or clinic every week for four consecutive weeks to receive epratuzumab. After the fourth infusion visit, you will return to the study doctor’s office in one week for a follow-up visit, where no epratuzumab is given. A telephone contact will occur four weeks after the follow-up visit. The schedule of study visits will repeat every 12 weeks for approximately of 96 weeks.
· If you are assigned to the 1200mg treatment group, you will come into the study doctor's office every other week to receive epratuzumab twice within 4 weeks. After the second infusion visit, you will return to the study doctor’s office in two weeks for a follow-up visit, where no epratuzumab is given. A telephone contact will occur four weeks after the follow-up visit. The schedule of study visits will repeat every 12 weeks for approximately 96 weeks.
After you finish the last 12-week treatment cycle, you will have your End of Treatment Visit (Week 96). A Safety Follow-up Visit will be performed four weeks after the End of Treatment Visit (Week 100).
If you leave the study early, you will be asked to complete an Early Withdrawal Visit. In addition, you will be asked to return to your study doctor's office or clinic 13 weeks after your last infusion of epratuzumab for a Safety Follow-up Visit.
The table below shows how the treatment cycles work and the last visits performed: The two columns on the right show when infusions would be given based on which treatment group you are assigned.
Treatment Cycle / Visit or Telephone contact / Time Frame After Previous Visit / 600mgInfusion / 1200mg Infusion
1 / 1 / 0 weeks (Study Entry) / X / X
2 / 1 week / X / No visit
3 / 1 week / X / X
4 / 1 week / X / No visit
5 / 1 week
5a Telephone Contact / 4 weeks
2 / 6 / 4 weeks / X / X
7 / 1 week / X / No visit
8 / 1 week / X / X
9 / 1 week / X / No visit
10 / 1 week
10a Telephone Contact / 4 weeks
3 through 8 / Treatment Cycles 3 through 8 will be similar to Treatment Cycle 2 shown above. The treatment cycles include Visits 11 (Week 24) through the final Telephone Contact 40a. at Week 92.
41 (End of Treatment/Early Withdrawal) / End of Treatment: 4 weeks after the previous telephone contact
Early Withdrawal: Upon your withdrawal
42 (Safety Follow-up) / 13 weeks after last infusion
Below you will find detailed information about the procedures done at each study visit.
Visit 1 / Enrollment:Before any study-related tests and procedures are performed, you will be asked to read and sign this Informed Consent Form and any authorization forms (as applicable). This visit will be performed for both treatment arms. Your study doctor and/or study staff will be performing the following tests and procedures upon entry into the SL0012 study:
· Determine your eligibility by reviewing study entry requirements.
· Collect your demographic (personal) information (date of birth and gender).
· Ask you to mark on a scale how active you feel your lupus disease is at the moment.
· Review with you your past and current medications including medicines you buy without a prescription.
· Measure your weight.
· Measure your vital signs (blood pressure, pulse rate, and body temperature). Your vital signs will be measured several times during this visit.
· Collect blood and urine samples for laboratory testing. Approximately 7 teaspoons of blood will be needed. For females who may be able to become pregnant, this includes a urine pregnancy test. The result of the pregnancy test must be negative (show that you are not pregnant) for you to participate in this study.