The Arthritis Internet Registry Goes Live

The project aims to mix social networking, clinical research and biospecimen collection to unravel the mysteries of a debilitating group of diseases.

By Brenda Goodman

8/2/2010  The Arthritis Foundation, working in conjunction with the National Data Bank for Rheumatic Diseases and Quest Diagnostics, has launched what many hope will become the largest registry of people with arthritis ever available to researchers.

The Arthritis Internet Registry, or AIR, which went live in June 2010, aims to harness the power of the Internet to connect people with arthritis to clinical investigators.

“The only way to really learn about the natural history of a disease is through a registry,” says John A. Hardin, Vice President, Research, for the Arthritis Foundation. “These diseases play themselves out over decades.”

Why Registries Are Important

In contrast to randomized controlled trials, or RCTs, which seek to enroll a homogenous group of patients – generally people who have very severe arthritis, but who don’t have complicating medical conditions that could muddy the conclusions of the study – patient registries like AIR are more inclusive and more reflective, experts believe, of the way people really live with diseases like arthritis.

Patients who take part in registries, for example, often have lower levels of disease, but more accompanying chronic conditions, like heart disease, depression or osteoporosis, which may complicate treatment options like medications and surgery.

Another important difference between registry-based studies and RCTs is that registries follow patients for many years, and even decades, to watch how a disease changes over time or to learn about the long-term risks of drug treatments, while RCTs may conclude after only a few months.

“The problem is that the only data that was published for years was data from randomized controlled trials,” says Joel Kremer, MD, a rheumatologist and the founder and chief executive officer of the for-profit Consortium of Rheumatology Researchers of North America, or CORRONA registry.

“They’re very valid studies, and they’re necessary evils, if you will, to get a drug approved by the FDA,” he says, “But I think we extrapolate the data from those trials to our everyday patients with some danger, and in order to fill in those gaps, you really need large registries, registries that are representative of what’s happening the country.”

Strength in Numbers

Like many registries, though, CORRONA enrolls patients chiefly through physicians who are based at academic medical centers.

As a result, less than three percent of rheumatoid arthritis (RA) patients in the U.S. are followed by registries.

A registry that enrolled just five percent of the estimated 1.5 to 3 million people in the U.S. with RA, as AIR aims to do, would have more than 100,000 members.

“[Through physician-based registries] We only get a small sample of the patients we need,” says Robert Plenge, MD, PhD, a rheumatologist and geneticist at Harvard University and a principle architect of the AIR.

Without larger cohorts, or patient groups, Dr. Plenge says, it’s very difficult to track “rare phenotypes, rare outcomes to find patients with multiple family members with RA. Those families are really hard to find.”

Large registries have already revolutionized medical care for many people with relatively rare diseases.

The Cystic Fibrosis Patient Registry, for example, which is managed by the Cystic Fibrosis Foundation, is credited with helping to nearly double the life expectancy of the estimated 30,000 people with cystic fibrosis in the United States.

How it Works

In contrast to the way other registries work, however, where people are enrolled through their physicians, anyone who has ever been diagnosed with arthritis can self-enroll in AIR, through the Arthritis Foundation’s website: (http://www.arthritis.org/arthritis-internet-registry.php).

“I thought, ‘I want to see how easy this is’,” says Kathleen Ferrell, a retired physical therapist with RA from St. Louis, Mo.

“I was in the car wash, using my iPhone,” says Ferrell. “It’s very convenient.”

The next day, she answered a follow-up questionnaire.

All told, she estimates that it took about 30 minutes to enroll.

“There are questions about your functional level, medications, activity, how often you have been to a doctor, how many times to a rheumatologist, out-of-pocket costs, things like that,” says Ferrell, a volunteer with the Arthritis Foundation since the 1970s who pushed for the registry’s creation.

Initially, in its pilot phase, AIR will focus on people with RA, but if it proves to be successful it may later incorporate active research arms for OA and other kinds of rheumatic diseases.

Once they pass the initial screening, which includes contact with the person’s physician and validation of their diagnosis, participants will be asked to fill out new questionnaires every six months.

Dr. Plenge says security and patient privacy are paramount.

“There are all sorts of safeguards in place to protect privacy,” he says. “There’s no link to personal information and no way I, as a researcher, could ever actually contact that person.”

A Link to Biospecimens

A key feature of the registry, and the one that’s perhaps most exciting to investigators, is the collection of blood samples that will be stored and analyzed in conjunction with the self-reported data.

“A major bottleneck in RA research is access to clinical data linked with biospecimens, for example DNA and serum,” Dr. Plenge says.

As part of the second round of information collection, participants will get a pre-printed order form that they can take to any Quest lab location. Quest will draw a blood sample and will test the blood for antibodies like anti-CCP and rheumatoid factor and for inflammatory markers like C-reactive protein. The results will become part of that participant’s numbered file, and some of the serum and blood will be stored for genetic studies and future analysis.

‘A Social Experiment’

While most registries never report their results or findings directly to patients, AIR has the stated goal of creating a social network where study participants can interact, supporting and learning from each other. And eventually, organizers say they want to be able to give people results from their own tests as well as larger group findings from the study.

“It’s kind of a social experiment,” Dr. Plenge says, “But I think it would be a really nice thing to do.”

It’s an experiment that has already worked at other sites. The Web community PatientsLikeMe, a social networking site for people with serious and chronic illnesses, has groups that actively participate in research and some that even generate their own investigations. The Amyotrophic Lateral Sclerosis (ALS) group, which has about 3,700 members, was able recently able to query its members about their experience with the drug lithium after early research suggested that it might benefit the disease. The results were immediately graphed and posted on the site.

“By using the Internet to query and interact with the research cohort, this platform significantly increases the efficiency and reduces the cost of recruiting participants and conducting research,” according to a company press release says.

The Ultimate Goal: Understanding Arthritis

Which is exactly the kind of potential the Arthritis Foundation sees in AIR.

And people like Kathleen Ferrell, who are passionate about accelerating the search for answers, can’t wait to get started.

“I think for those of us who have [RA], there’s an additional mission here, to make this work,” Ferrell says. “We can see and feel the importance. You just feel this emotional need to have better medicines, to find out what happened: ‘Why do I have it and what’s going to make it okay?’”

But she also knows that those kinds of answers don’t come from a single person’s search.

“It’s something that can make a huge difference, but we have to have people sign up.”

If you'd like to enroll in the Arthritis Internet Registry or find out more, click here.

To learn about the Arthritis Foundation Research Program, click here.