By KATINA TENGESDAL, Staff Writer, email@example.com
Trinity Health's clinical studies department has about 20 ongoing clinical trials, three of which are in the area of rheumatology. Dr. Erdal Diri, rheumatologist, has been involved with numerous clinical research studies involving treatments for rheumatic diseases such as rheumatoid arthritis, fibromyalgia and lupus.
"We're excited to be a part of the rheumatoid arthritis trials now," Diri said. "Rheumatoid arthritis is a chronic, disabling disease. These rheumatic diseases used to be treated very differently. We didn't have many options to offer patients. We would treat them with chemo type drugs, or high-dose steroids."
Katina Tengesdal/MDN - - Dr. Erdal Diri, rheumatologist for Trinity Health, looks over protocols for clinical trials.
Katina Tengesdal/MDN - - From left, staff members of Trinity’s clinical studies department: Janelle Rostad, licensed practical nurse and certified clinical research coordinator; Natalie Quam, certified clinical research coordinator; and Lisa Vandewalle, secretary and research assistant.
"Since the late 1990s, there have been breakthroughs in treatment," he said. "We now have a class of drugs called biologics, that have found to be successful in slowing the disease progression and controlling the disease."
While biologics have been a breakthrough, there are still some problems. With newer classes of drugs, physicians hope to improve treatments further.
"The problems we're facing now are that the patient has to inject the drugs or we have to give them an IV, and patients develop a resistance to the drugs over time. We needed a new type of drugs, that are as affective as biologics but can be given in a pill form and can be effective over a long period of time," Diri said.
The new drugs, now in a clinical trial, are in the last part of the clinical trial phase. The last phase of the trial is testing for long term efficacy and safety.
"The drug has already been shown to work, and we are now studying the long term effects. The drug, which is taken in pill form twice a day, will be on the market in the next two or three years. It will open a new door for rheumatoid arthritis treatment," Diri said.
The patients currently in the trial have been happy with the treatment so far.
"Most of those who are in the trial have had failed treatments with other drugs," Diri said. "A couple of them will be in this trial for more than a year, and they don't have an obligation to continue if they don't feel it's working."
Clinical trials are restricted to the number of patients that can be involved, as well as inclusion and exclusion criteria.
"We don't advertise the trials," Diri said. "We usually choose patients from our own patient population, and they can choose to participate. When going into a trial, patients have to be educated about it, and they are closely monitored."
"We provide the patient with a copy of the trial protocol and they can take it home and review it," he added. "If they decide they want to do it, then they are screened and chosen for participation if they meet criteria. Patients in the trial also discuss all of their treatment options. Participation in a trial is just one more option we can give them."
Patients often choose to participate in clinical trials not only because they hope the new medications will offer a benefit to them, but because they want to help out the next generation of patients, Diri said.
In Trinity's rheumatology department, there are generally several ongoing clinical trials. Diri said the site is also about to be accepted for new trials, including new trials in rheumatoid arthritis, lupus, ankylosing spondylitis and fibromyalgia.
"These diseases are not curable right now," Diri said. "Until two decades ago, we didn't even have many options. We're trying different drugs that are more effective at keeping patients going. Our goal is to hopefully find a cure some day."