Frequently Asked Questions
(ACURIAN PROJECT CODE: 1096)
  1. Study Questions
I.   Study Questions:
The Disease:
What is Rheumatoid Arthritis?
Rheumatoid arthritis is an autoimmune disease that causes chronic and persistant inflammation of the joints. Rheumatoid arthritis can also cause inflammation of the tissue around the joints which causes pain and swelling.
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Clinical Trials:
What is a clinical trial / research study?
A research study involves people and is conducted by qualified research physicians to evaluate an investigational treatment for a specific disease or group of diseases. Before the study treatment is given to subjects in a clinical study, it is researched in the laboratory. Clinical research studies provide a way to test investigational treatments. All treatments in widespread use today were first proven effective and safe in clinical studies.
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What are the risks and benefits of participating in a clinical trial?
Most eligible patients enroll in a clinical trial because they hope that they will personally benefit from the study-related medical treatment and study medicine they receive, or because they want to help advance medical science, believing they can help other patients who may some day benefit from what is learned in the study. However, there can be no benefits promised to you if you elect to participate. The study doctor will discuss the risks and benefits with you.

You will be presented with an Informed Consent document that every study subject must understand and sign before enrolling into the study. The Informed Consent lists -- in detail -- the most common known risks and side effects of the investigational drug.
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Who is the sponsor of the study?
If you pass this telephone screen, you will be contacted by a member of the study doctor's team that will assist you in answering this and other important questions you have about study participation.
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Who is Acurian?
Acurian helps people and caregivers find study doctors who are running research studies. Subjects in research studies help researchers learn more about the new experimental drugs and treatments before they can be considered for FDA review and potential approval for use by the general public. In this way, Acurian helps to speed up the research process for new investigational medicines. For more information about Acurian and clinical trials, visit their web site at www.acurian.com.
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Who qualifies for this study?
Basically, we are looking for individuals between the ages of 18 to 80 years who have been diagnosed with rheumatoid arthritis. Would you like to go through the telephone evaluation to see if you may be a candidate for this study?
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Where are the research sites?
There are approximately 20 centers in the United States that are helping to conduct this research study.
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When will I know if I qualify for this study?
If you pass this telephone pre-screen and we find that you might qualify to enroll in this research study, you will be contacted by a member of the study doctor's team-they may ask you more questions to further assess if you should participate in this study. If they believe that you should be considered, you will be asked to schedule an appointment at the doctor's office (or clinic) for further evaluations. When you go to the doctor's office, the study doctor and his/her team conduct study related examinations and tests to see if you can be enrolled into this study.
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How long will the study last?
This research study will last approximately 20 weeks. During that time, participants will need to visit the research site at least 6 times.
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What is the purpose of this study?
The main purpose of this research study is to evaluate the efficacy and safety of an investigational medication in patients with active Rheumatoid Arthritis.
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Will I receive the drug or a placebo (inactive substance)?
This is a placebo-controlled study. You will receive either the investigational drug or placebo.
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What drugs will I be given?
You will have the opportunity to discuss this with the participating study physician and designated staff members prior to your participation in this research study.
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What are the side effects of this drug?
You and the qualified study physician can discuss the potential benefits of this investigational medication and review the possibility of experiencing any side effects associated with this study medication before you begin the actual study.
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Does my doctor have to give his/her permission?
No, but either you or, with your permission, the study doctor might want to contact your personal physician.
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Should I still see my family doctor?
Subjects are encouraged to see their family doctor for routine medical care.
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Will my family doctor be kept informed of my progress and test results?
We encourage you to talk with the study doctor about how, with your permission, he/she will involve and/or inform your personal physician.
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Reimbursement Issues:
The sponsor did not provide any information about reimbursement for transportation. If this is a concern to you, please alert the participating doctor's study team members to discuss possible assistance.
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Will the treatment be free?
All study-related examinations, tests and treatments, including the study medication, will be provided at no cost to you.
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Miscellaneous/other questions
If the caller has specific medical questions:
Your doctor or healthcare professional is the best source of information to answer your question.
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Any other questions:
I'm sorry but that information has not been made available to me. The doctor's study team will be able to answer that question for you.
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Glossary
Alzheimer's Disease
A neurodegenerative disease characterized by progressive cognitive deterioration together with declining activities of daily living or behavioral changes. It is the most common type of dementia.
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Anemia
A medical condition that occurs when a person does not have enough red blood cells.
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Birth Control (Men Only)
Study participation requires sufficient use of birth control to participate in the study such as condoms or spermicide.
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Cancer/Malignancy
Cancerous or diseased cells that have the capacity to spread, invade, and destroy tissue. (Skin cancer - a.k.a. basal cell carcinoma).
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Cardiovascular Diseases
Arteriosclerosis, angina, high blood pressure, high cholesterol, heart attack, stroke, arrhythmia and heart disease.
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Hysterectomy
A hysterectomy is an operation to remove the uterus (womb).
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Kidney disease
A disease affecting the kidneys, especially one that requires dialysis. Dialysis is the use of an artificial kidney machine required to keep a person alive.
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Liver disease
A disease affecting the liver, such as hepatitis B and hepatitis C.
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Menopause
Menopause is when menstruation permanently stops
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Oophorectomy
Removal of the ovaries.
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Pancreatitis
Inflammation of the pancreas
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Parkinson's disease
A degenerative disorder of the central nervous system that often impairs the sufferer's motor skills and speech.
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Placebo
Placebo is an inactive substance or preparation used as a control in an experiment or test to determine the effectiveness of a medicinal drug.
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Rheumatoid Arthritis
Rheumatoid arthritis is an autoimmune disease that causes chronic and persistent inflammation of the joints. Rheumatoid arthritis can also cause inflammation of the tissue around the joints which causes pain and swelling.
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Stroke
The loss or alteration of bodily function that results from an insufficient supply of blood to part of the brain is called a stroke.
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Tubal ligation
A method of female sterilization in which the fallopian tubes are tied during a surgical operation.
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