INTRODUCTION: You are invited to participate in
this research study as you have been selected by our study experts and met the
requirements for participation in our study. Before participating in the
following study, it is important that you read thoroughly and understand the
following information; also, it is completely voluntary if you wish to
participate or not. Below describes the study’s purpose, procedures, benefits,
risks, duration of study, and compensation for the participants. You will be
asked to sign this informed consent and it may be difficult understand but rest
assured as you can consult the study experts or members of the study to better
explain the informed consent
PURPOSE: The purpose of study is to see
how well you respond to sarilumab, a biologic disease modifying anti-rheumatic
drug (DMARD), compared to another biologic drug called etanercept, after it was
determined that patients with moderately to severe rheumatoid arthritis (RA)
had an inadequate response to other disease modifying
antirheumatic drugs such as methotrexate (MTX).
This study will be multistate, Maryland, Virginia, Delaware, and Washington DC,
for 24 months. Our target population is adults, male and female, >18 who
have had an inadequate response or intolerance to one or more DMARDs and have
moderate to severe RA. Each group with 250 patients will either receive
Sarilumab or Etanercept. Patients will
start 4 weeks of treatment with initial dose of either Sarilumab 200 mg
injection biweekly and etanercept 25 mg/0.5 mL injection weekly (injection
site, abdomen, or thigh). At visit 3,
the dose of Sarilumab will be reduced to 150 mg biweekly and etanercept will be
increased to 50 mg/mL weekly for 4 weeks.
At visit 4, all participants will have reached the targeted dose. The
trial will continue with visits occurring every 4 weeks for the first 6 months,
then every 3 months thereafter until 24 months.
At each visit, you will be assessed for safety and tolerability to
medications. Since Sarilumab is a biweekly dose, we will need to include a
placebo to keep this study blind meaning you nor the study investigator would
know what medication treatment is given to you and measure the number of
patients who require methotrexate in addition to the injections.
If you qualify for this study and decide to
participate, you will be asked to sign this consent form before beginning any
of the studies’ activities. You will be required to do the following tests and
procedures for study purposes only:
will be assessed for a tuberculosis test (TB)
complete examination of your joints
will also be asked to complete several questionnaires about how you are feeling
and how rheumatoid arthritis is affecting you
physical examination is performed
In an initial study to determine the
efficacy and safety of Sarilumab (the Monarch study), the DMARD drug showed
reduction in disease activity and improvements in the signs and symptoms (S/Sx)
of RA. In this study, Sarilumab was well tolerated by the subjects with RA but
there is still a chance you may experience some side effects of the medication.
It is important that you report any side-effects you experience from this drug
to the study coordination. Expected side effects of this medication include the
following: Laboratory abnormalities like low blood cell count, low neutrophil
blood cell count, elevation in liver function tests, and elevations in
cholesterol. Another side effect is infections such as colds, urinary tract
infections, and may increase the risk of tuberculosis, that is why it is
imperative you get a TB test before participating in the study. Rare side
effects which may occur, and you must immediately contact your study doctor
are: diarrhea, vomiting, warm/red swollen skin, difficulty breathing, burning
or pain when you urinate, and sudden or severe headaches.
anti-tumor necrosis factor), also called a DMARD drug has been used for many
years to treat diseases like RA. It also helps reduce inflammation and improve
RA. The most common side effect related to this medication include: skin
reactions like burning or itching at the injection site, increased risk
infections like fungal infections and TB. Sarilumab may be harmful in pregnant
but it is still unclear what effect the medication has on unborn babies.
BENEFITS: Medications like etanercept have
already shown that they improve signs and symptoms of RA, as well as slow down
the damage to the joints. It is anticipated that Sarilumab will significantly
reduce the signs and symptoms of RA as well as slow down damage to the joints.
Your participation in this study will provide new information regarding the
effects of Sarilumab in the study.
ALTERNATIVES: If you decide not to participate
in the study, there other treatment options available like other biological
drugs, including anti-tumor necrosis factor drugs, or glucocorticosteroids.
Questions regarding the best treatment of choice, contact your primary care
COMPENSATION: For participating in this study,
you shall be rewarded a $50 Walmart gift card and for every visit you make you
will be paid $30 and available parking.
In the study, if you
become ill or injured due to administration of a drug under protocol, medical
care will be attended to you and all medical bills shall be paid by the sponsor
of the study.
You will be asked
to sign the Health Insurance Portability and Accountability Act
(HIPAA)Authorization, so records of your participation in the will be
confidential until permittable by you and in case the study is published or
presented you shall remain unidentified.
FOR QUESTIONS: if
you have any question or complaints about this study or your participation in
it, or if you experience any injury or side effects, contact: NDMU investigators,
Joan Nchumuluh and Ateeyeh Atefat at (888-705-9845) or NDMU IRB at (888-777-6105).
TO REFUSE OR WITHDRAW:
Your decision to participate in this study is completely voluntary. You have
the right withdraw from the study at any time; no penalties or loss of benefits
entitled to you will be affected following your refusal to participate in the
study. However, you may be removed from the study if study procedures are not
followed, if the study is terminated for any reason, if maybe you do not
consent to continue after being told of changes in the study that may affect
you. Also, all medications or unused study medications must be returned if you
withdraw or are removed from the study.
All the information
has been explained to me and had the opportunity to ask questions. My signature
below indicates that I voluntary agree to participate in the study as described
in the document and will receive a copy of this document.
To the best of my
knowledge, the subject signing this consent form has had the study
fully and carefully
explained by me and the subject has been given the opportunity to
ask questions regarding
Printed Name of
Person Obtaining Consent
Signature of Person
Obtaining Consent Date