Select Page

ABOUT CLINICAL RESEARCH

It’s a New Day for Rheumatoid Arthritis and Other Rheumatic Diseases*

*osteoarthritis, myositis, lupus, scleroderma, and other auto-immune diseases

 

IF YOU HAVE RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS, LUPUS, OR OTHER RHEUMATIC DISEASES AND YOU…

  • Aren’t able to afford your medications
  • Haven’t improved enough with your current treatment
  • Want to help develop new treatments for yourself and others

THEN YOU…

  • May be interested in participating in a research study of potential new treatments for these conditions
  • May want to learn more about how to become a part of our study group

IF YOU WERE TO PARTICIPATE IN A RESEARCH STUDY TESTING A NEW MEDICATION, THEN YOU…

  • Would be able to continue most of your same arthritis medicines so that the risk of getting worse would be low
  • May have a chance of getting placebo for a limited period of time but an even better chance of receiving active medication (usually 2 or 3 to 1)
  • Would be guaranteed to receive the medication after the initial phase of the study for up to 5 years in many cases
  • Would not have to pay to doctor visits or lab tests but would instead be compensated for your participation

WHY SHOULD YOU PARTICIPATE?

  • To help advance the treatment of RA for yourself, your children, and others who may develop the disease
  • To gain access to medications that you might not otherwise be able to try
  • To decrease some of your healthcare costs
  • To make a contribution

THE DEVELOPMENT OF NEW MEDICATIONS AND CLINICAL TRIALS

The treatment of RA and some of the other rheumatic disease has come a long way since the introduction of biologic treatments such as Enbrel, Remicade, Orencia, and Rituxan. The “biologics,” as they are called, are very effective and help from 60-70% of patients who have failed all other treatments. But, not everyone improves with the available biologic treatments and not everyone who improves experiences major improvement. Most patients will still have some pain, swelling, and stiffness after treatment with the biologics. And, the disease is rarely put into remission or cured. Currently available biologics are also very expensive, even for those who have good health insurance. For these and other reasons, new treatments are needed.

Testing of New Treatments

Most new treatments are based upon advances in our understanding of how the disease actually causes pain, inflammation, and joint damage. This understanding comes from investigations in the laboratory where the molecules involved can be identified and further characterized. This information is then used to design a drug which will block the particular molecule or molecules causing the problem.
The next step is to test the drug in animals. What works in the test tube doesn’t always work in the real world. If it appears safe and possibly effective in animals, then testing in patients is begun. Testing in patients is necessary for a variety of reasons, but, most importantly, because animals don’t actually have rheumatoid arthritis (RA), psoriatic arthritis (PSA), lupus (SLE), etc. The animal models, as they are called, may have arthritis or a condition which resembles the human disease, but no animal has or gets the exact rheumatic disease. Generally, testing in man begins in a very small number of special patients with very small doses of the medication. These doses are then gradually increased until the desired effects are seen or until side effects develop. When the correct dose is found, then further, larger scale testing, is usually begun. It is this testing that will prove conclusively whether the medication works in the majority of patients with RA and whether or not it should be approved by the Food and Drug Administration for general use.
When the drug enters this final phase of testing, usually hundreds of patients have already been treated and millions of dollars have been spent. When the company developing the medicine decides to proceed to this final phase of the research, they usually have good reason to believe that the drug will work because they will be investing more than $500 million in the testing.

Participation

Generally, new medications are tested in those who have failed standard treatments by adding the new medication to the standard treatment and observing for additional improvement. However, since most patients want to get better and most physicians want their patients to improve, there is a risk that the power of positive thinking could influence the results and lead to an erroneous conclusion. This “placebo” effect, can result in what seems like improvement in 30-40% of patients. For this reason, the new medication needs to be compared to something which is known not to work, like a sugar tablet or sugar water. These inactive treatments are known as placebos. Almost all studies use placebos. But, in most studies, patients are on placebos for a limited period of time (usually 12-16 weeks). During this period, study subjects generally remain on all the same medications they were on previously so that they would not be expected to get worse. If however, a patient does become worse, then either the patient stops the study, or else she/he moves on the second phase of the study where they receive the real medication. And, almost all studies guarantee the patient a chance to receive the new medication even if the patient received the placebo for the first part of the study. And, most studies also offer guaranteed treatment with the new medication for a number of years (generally 2-5) so that everyone in the study has a chance to see if it is really going to work for them in the long run and be safe.

The chance of getting the real medication (as opposed to the placebo) varies from study to study, but generally 2 out of 3 or 3 out of 4 subjects will get the real medication from the beginning. One out of 3 or 1 out of 4 patients will get the placebo starting off but will eventually get the real medication after the first 12-16 weeks.

What Is Involved

If you contact us with an interest in participating, we will do our best to describe the study over the phone and answer any questions you may have. We will also ask you questions about your diagnosis and your current and previous treatments.
If you are still interested, and it appears as if you may qualify, we will schedule you for a preliminary visit to determine your eligibility. Prior to the visit we will ask your permission to obtain your medical records to ensure that you will otherwise qualify.

Preliminary Screening Visit
The visit will take place at 10495 Montgomery Rd, Suite 26, Cincinnati, OH 45242. The office is located just opposite the main entrance to Bethesda North Hospital.

At the first visit you will be…

  • Given a written description of the study which will provide information on the risks and benefits of participating and what is involved in your participation. (Informed Consent Statement).
  • Asked to complete several questionnaires about the severity of your arthritis and how it affects your day to day function
  • Examined by 2 of our rheumatologists to establish the activity and severity of your disease
  • Have blood drawn to make sure you are otherwise healthy and to confirm the diagnosis and activity of your disease.
  • Asked to have an EKG and a chest x-ray according to the particular study requirements

Subsequent Visits

If you meet all the eligibility requirements, we will contact you and schedule you for your first visit at which time you will receive study medication.

This first visit is usually the longest and may take up to 2 hours. Subsequent visits are usually shorter. Subsequent visits occur on average once a month for the first 6 months and every 2-3 months thereafter.

Subsequent visits generally involve completing questionnaires as you did on your previous visits, being examined by a rheumatologist, and having your blood drawn and study medication dispensed.

The Costs

There are no costs to you. In fact, you will be paid for your time and transportation. The compensation depends upon the study but ranges from $25 to $75 per visit.

About Us

Cincinnati Rheumatic Disease Study Group
10495 Montgomery Road, Suite 26
Cincinnati, OH 45242
(513) 559-2130

Connect With Us

1000 Patients Helped by 18 Rheumatologists Since 1991!

Copyright ©2019 - Cincinnati Rheumatic Disease Study Group. All rights reserved. Internet Presence by Main Street Marketing

About Us

Cincinnati Rheumatic Disease Study Group
10495 Montgomery Road, Suite 26
Cincinnati, OH 45242
(513) 559-2130

Connect With Us

1000 Patients Helped by 18 Rheumatologists Since 1991!

 

Copyright ©2019 - Cincinnati Rheumatic Disease Study Group. All rights reserved.
Internet Presence by Main Street Marketing