Study focuses on rheumatoid arthritis

That’s one reason why St. John’s Health System is in the midst of a Phase III rheumatoid arthritis drug study, one of about 100 sites nationally testing a new drug that manufacturer Roche hopes to have approved by the Food and Drug Administration within the next 18 months.

“Research is not necessarily a treatment, it’s an option,” said Pete Miles, director of St. John’s medical research, “because we don’t know if it’s a proven therapy yet.”

The studies help three groups separately. Drug manufacturers get access to a third-party testing apparatus needed for FDA approval; hospitals and other research organizations get to stay abreast of the newest treatment options and gain an element of prestige associated with the research; and patients who qualify for the studies get a shot at treating their disease at no cost to them.

Signal proteins

Dr. Anne Winkler, principal investigator for the rheumatoid arthritis study, said the drug uses signal proteins, called cytokines, to halt the inflammation and joint problems caused by rheumatoid arthritis. The study comprises six monthly injections, she said.

Winkler said more than 3 million people, or about 3 percent of the American population, suffer from rheumatoid arthritis. Most victims, she said, are age 20 to 50, and the malady is more common in women than men.

“One of the reasons why it’s such a devastating disease is that it affects young people at the time that they’re building their careers, having a family,” Winkler said. “Half the people with rheumatoid arthritis are disabled in 10 years.”

Access to treatment

She said that as part of the agreement between Roche and St. John’s, patients participating in the study may be allowed to continue the new therapy for up to five years at no charge.

“It’s allowing our patients to get access to a very expensive drug for an extended period of time,” she said.

St. John’s has been conducting Phase III drug trials, which examine drug effectiveness and side effects during the last step before securing FDA approval, for eight years with 50 to 60 studies ongoing at any given time. Rheumatology has conducted more than 20 drug studies during that period.

Drug companies solicit hospitals, clinics and universities nationwide to conduct the studies.

If a hospital or other organization agrees to conduct a study, the drug company foots the entire bill, including reimbursing some salary costs.

Miles said he couldn’t disclose how much Roche paid St. John’s to conduct the current study, but he said similar studies cost an average of $3 million to $4 million. He said drug companies spend around $1 billion from start to finish for each drug they develop.

“We’re not doing research here to make a profit,” Miles said. “What we’re trying to do is to offer an additional treatment option to patients.”

Winkler noted that any money left over after the current study is completed will be given to the charitable St. John’s Foundation for Community Health.