Before Joining an RA Clinical Trial, Ask Your Healthcare Provider These Questions

Rheumatoid arthritis (RA) is a type of inflammatory arthritis in which the immune system malfunctions and attacks the synovium—the connective tissue lining your joints. RA can also affect other body parts, including the skin, eyes, and heart.

The exact cause of RA is unknown, but researchers think genetics and environmental factors might be to blame. Treatment options for RA include medication, lifestyle therapies, physical and occupational therapy, assistive devices, and surgery.

There is no cure for RA, but most people can manage symptoms for decades or most of their lives. An unfortunate smaller group, however, might experience severe disease symptoms and ongoing progression (RA that continues to get worse). They may experience damage to cartilage, bones, and joints, which can lead to bone-on-bone pain and severe pain and swelling of joints.  

People with severe RA likely have tried different treatment options, and their RA continues to worsen. These treatments are costly.

In these cases, healthcare providers might recommend clinical trials to reduce treatment costs or to try a new treatment when effective treatment options have run out. Research shows clinical trials can be a cost-effective tool for bringing down healthcare expenses.

You don't have to have severe RA to enter a clinical trial. People with mild to moderate disease can also enter clinical trials and help researchers better understand RA and advance new RA medicines and treatment strategies.

The decision to enter a clinical trial is not an easy one. Fortunately, your healthcare provider can be a valuable resource. They can answer questions about RA trials and help you find one that could best help you.  

This article will cover the benefits of entering a clinical trial for RA, the drawbacks, and questions to ask your provider.

Benefits of Clinical Trials for RA

A clinical trial is medical research conducted on people. RA studies might evaluate new drugs and treatment options, explore preventive therapies, or investigate surgical procedures. Goals in RA studies might be to learn more about the disease, a new medication, or a promising treatment strategy.

There are plenty of reasons you might want to participate in a clinical trial. Benefits of participating in an RA clinical trial might include:

• Trying new RA treatments before they become available to the public
• Helping to advance RA treatments and treatment guidelines
• Receiving free RA care, including healthcare provider appointments, physical examinations, blood work, and imaging
• Taking a more active role in your medical care
• Getting expert medical care from leading healthcare institutions
• Gaining more knowledge on RA
• Accessing information about support groups and resources
• Getting paid, in some instances

Drawbacks  

Just as clinical trials have benefits, they also have drawbacks.  

Disadvantages of participating in a clinical trial might include:  

• Attending more health visits than you would with your regular rheumatologist (a doctor who treats arthritis conditions)
• Undergoing uncomfortable treatments, hospital stays, or frequent trips to the study location
• Getting no relief from the studied treatment
• Experiencing adverse or severe side effects from the study medicines that only become known during the trial
• Being part of the control group and receiving a placebo (inactive drug) instead of the active new drug 

Questions to Ask Your Healthcare Provider 

If you are thinking about taking part in a clinical trial, you should find out as much as you can about the study before you decide to participate. Your healthcare provider can answer many of these questions. 

Eligibility 

Questions on eligibility may include:

• Is this RA clinical trial a good fit for me?
• Do I qualify based on any blood work requirements?
• Are there other clinical trials that might help me?
• What are my treatment options if I do not qualify for this trial? 

Treatment and Testing 

Questions include:

• What is the purpose of this clinical trial?
• Why do researchers think this new treatment might help people with RA?
• How long will the trial take?
• When will I find out the results of the clinical trial?
• What if I get a placebo drug rather than the treatment under study?
• How does the clinical trial drug compare to other treatment options for RA?

Cost and Transportation  

Questions include:

• Where is the site location?
• Will I be reimbursed for travel costs and times?
• Is there any financial incentive?
• Will I need to take time off from my job?
• Will I be reimbursed for missing work? 

Safety  

Safety questions include:

• Has this treatment been tested for safety?
• How will I know the treatment is working?
• What are the benefits and risks of this new treatment? 

Type of Clinical Trial  

Questions include:

• Have there been other trials like this one? What were those results?
• What types of RA patients will be in this trial?
• What phase is the trial in, and what does that mean?

Side Effects  

Questions on side effects include:

• What are the possible risks of this new treatment?
• Which medication side effects can be managed?
• Which side effects should I bring up to the study's coordinators? 

Patient Rights  

Questions on patient rights include:

• How could this clinical trial help me?
• Who will pay for treatments?
• Can I quit a clinical trial?
• Will my health information be protected? 

Standard vs. Experimental Treatment

The Food and Drug Administration (FDA) ensures all drugs marketed in the United States are safe and effective for human use.

The FDA considers treatments it has previously reviewed and assessed for risks standard treatments. Standard treatments are those available to benefit individual patients based on patient need assessments and guided by medical boards, state regulations, and more. They are covered by health insurance plans,

Experimental treatment is different from treatment your healthcare provider prescribes. According to the FDA, experimental treatments are intended to benefit future patients.

Clinical studies are paid for by drug manufacturers and government agencies. They require informed consent (a detailed communication process) and provide a periodic and systematic assessment of patient data. They are protected by review boards, professional and legal standards, government agencies, and informed consent legal guidelines.  

When treating people with RA, healthcare providers rely on information from clinical trials and their experience in clinical care. However, these resources will differ because studies rely on a minority of candidates seen in medical practices, and assessment measures in clinical trials will vary from what is used in clinical practice.

Summary  

During a clinical trial, researchers try to determine if new medicines, therapies, and strategies are safer and more effective than current treatments. The decision to enter a clinical trial is not an easy one. 

If you are interested in learning more about clinical trials for rheumatoid arthritis, your healthcare provider can answer many of your questions. They might also have information about studies that might help you save money and better treat your RA.

They can also share information about the benefits and risks of a particular trial, the types of clinical trials available, eligibility, side effects, other safety information, treatment and testing, and your patient rights.  

A Word From Verywell

Clinical trials come with unknowns, which can cause people to be fearful and anxious with concerns about their privacy, care, and safety. You can ease your worries by getting a clear understanding of what an RA clinical trial might involve before you agree to participate.  

Personal information gathered during a clinical trial is confidential and reported results will not have your name attached to them. Your care will be in the same places standard RA care is given—typically at rheumatology practices and clinics or another healthcare setting.  

Clinical trial participants are closely monitored so the healthcare providers managing their care can quickly assess and address any side effects or adverse reactions.

If you and your healthcare provider determine the clinical trial is not benefiting you, you may quit the trial without penalty. Leaving the clinical trial will not affect your access to future RA treatments.