How to Sign Up for a Rheumatoid Arthritis Clinical Trial

Joining a clinical trial may have benefits if you have rheumatoid arthritis. Rheumatoid arthritis (RA) is a type of inflammatory arthritis that occurs when the immune system malfunctions and starts to attack healthy tissues, mainly the synovium (the lining of the joints).

RA causes inflammation (painful swelling) in the joints—primarily the hands and wrists, but any joint can be affected. Lasting and untreated inflammation of the joints can result in joint damage and disability. RA can also affect other tissues throughout the body, including the eyes, heart, and lungs. 

RA is an expensive condition to treat. Treatment typically involves medications, assistive devices, surgery, physical therapy, and occupational therapy. These expenses can quickly add up. Depending on your insurance coverage, you may have to pay a significant amount out of pocket.

According to a 2018 systematic literature review (a review of a selection of scientific research studied to answer a specific question) in the medical journal Arthritis Care & Research, annual RA costs for RA patients using any treatment plan averaged $3,723. For those who used biologic drugs, it averaged $20,262.

If treatment costs are a problem for you, you might benefit from participating in a clinical trial. Joining a clinical trial can allow you to receive study medicines at no cost. You may also consider a clinical trial if you have severe RA and other treatments haven’t worked. You might even find a medication that treats your RA better than anything you have tried before.  

This article will cover reasons to participate in a clinical trial for RA, steps to enroll, eligibility, and safety.  

Reasons to Participate in Clinical Trials for RA

Clinical trials play a crucial part in medical research, leading to discoveries that end up helping millions of people. But most clinical trials are often under-enrolled and poor recruitment is a problem in the United States and worldwide.

According to a 2022 report in the peer-reviewed journal PLOS One, the Institute of Medicine cited 71% of phase 3 trials approved by the National Cancer Institute (NCI) and 40% or more NCI-sponsored trials closed without meeting enrollment goals. The report’s authors note that under-enrollment results in high costs and wasted resources for the trial sponsors, researchers conducting trials, and society.

There are different reasons why people don’t participate in clinical trials, including safety concerns or because they might be unaware that a trial exists. But clinical trials are necessary because their goal is to determine how well a medication or treatment strategy works on people. Without this vital research, newer, better treatments cannot become available to the general public. 

There are different benefits to being involved in an RA clinical trial, including: 

• Taking a more active role in your health care
• Getting access to a new treatment before it is available to the public
• Getting expert medical care at a leading healthcare facility, such as Johns Hopkins, Cleveland Clinic, or Mayo Clinic
• Helping others, including future generations, by contributing to the medical research
• Receiving a treatment that works for you when other treatments have failed
  
• Free treatment, along with evaluations, such as healthcare provider appointments, physical examinations, lab work, imaging, and other tests
• A better understanding of RA, including learning about conditions that RA might increase your risk for, such as heart disease

Where to Find an RA Clinical Trial

Many medical institutions and government agency websites can help you find an RA clinical trial near you. Your healthcare provider and their medical staff may also have information about research in their medical institutions.  

If you find a research study that interests you, consult with your rheumatologist or other healthcare providers to determine if the clinical trial might be a good fit.  

Websites that can help you locate an RA clinical trial include:  

• American College of Rheumatology
• Arthritis Foundation
• Cleveland Clinic
• Clinical Trials GPS
• Clinicaltrials.gov
• Johns Hopkins Arthritis Center
• Mayo Clinic
• National Institute of Arthritis and Musculoskeletal and Skin Diseases
• Trials Today

Steps to Enroll in RA Clinical Trials

Once you find a clinical trial that meets your needs, you will need to review the eligibility information, give informed consent, attend pre-research testing, and ask questions. 

Review the Eligibility Criteria 

Not every RA trial will be a good fit for you. For example, one 2015 report in Arthritis & Rheumatology notes that RA clinical trials often exclude people with low C‐reactive protein (CRP) levels (inflammatory markers found in blood work).

Other criteria that determine eligibility or ineligibility might include sex, age, how advanced RA might be, or certain medications you may have taken in the past. 

If you need help understanding the eligibility criteria for an RA study, talk to your healthcare provider or reach out to the study’s organizers.  

Give Informed Consent  

Informed consent begins with education about a clinical trial before you even start. The research team will explain the trial goals, the trial length, what will happen, risks and benefits, and privacy information.

If you decide you want to participate, you will sign the consent form that details all the information the research team has given you. You can keep a copy to review and refer to any time. Even with the consent form signed, you can leave the study at any time for any reason.

That informed consent stays throughout the clinical trial. This allows the research team to update you on your progress and any newly identified side effects and risks.  

Pre-Research Tests  

A clinical trial may require you to undergo pre-screening to be eligible. A series of assessments is usually part of the trial protocol. This might include a physical examination, a review of your medical history, imaging, and laboratory testing (blood and urine tests).

Also, you may be asked to complete a questionnaire that might ask about specific symptoms, how long you have had RA, its severity, how pain affects you, medications you have previously used to treat RA, and more.  

Questions to Ask Researchers  

If you decide you are interested in a clinical trial, you will want to ask as many questions as possible to help you best understand what will be happening.

Some questions to ask are:  

1. What is the purpose of the study?
2. Will I be reimbursed for expenses I incur?
3. What kind of testing is needed throughout the study?
4. What are the study treatment’s possible risks, side effects, and benefits?
5. How will this trial affect my daily life?
6. What is the length of the trial?
7. Who will be in charge of my care?
8. Who will pay for the treatment?
9. What type of long-term follow-up will there be?
10. How will I know if I get a placebo drug (one that is inactive) or the drug being studied?
11. Will the trial results be provided to me?

Factors That May Affect Eligibility

There are factors that may affect your ability to participate in a clinical trial. For example, many trial participants live far away from trial site locations. They may not have access to reliable transportation, and public transit may not be an option.

In addition, the cost of transportation—gas and automobile expenses, ride-share services, or public transit—can add up. These costs can lead to missed appointments.  

In addition, trial participants might incur childcare costs or need to take time away from work. A clinical trial requires a time commitment to go to appointments, travel to site locations, or stay in the hospital—and that is time away from family and work.  

In a 2018 study reported in the medical journal JAMA Network Open, 49% of study participants reported that being a part of a clinical study disrupted their daily routine.

Safety Standards 

Before recruitment for a clinical trial starts, researchers will study new treatments in lab experiments. Once those studies find the treatment safe and effective, the next step is to try the treatment on animal subjects. Human trials do not begin until research can confirm that a specific drug or treatment is safe and effective in people.   

The Food and Drug Administration (FDA) regulates all clinical trials in the United States. Every trial is reviewed, approved, and watched over by an independent panel of doctors, researchers, and the institutional review board (IRB).

The IRB ensures study participants’ safety, welfare, and rights. It also confirms that studies are ethically conducted and that health risks are reasonable compared to the benefits.

You Can Leave at Any Time 

Even with proper safety measures, you can still experience adverse reactions, severe side effects, or discomfort from treatments or trial methods. If you find you cannot continue in the clinical trial because of side effects, pain, time commitment, or any other reason, you can quit the study. Studies are voluntary, and you can leave without any penalty.

When you decide to leave, you should let the research team know that you are withdrawing. You may choose to provide the research team with your reasons for leaving, but you are not required to do so.

Estimated Patient Costs  

The study’s sponsors are responsible for costs associated with the research, so participants should not have out-of-pocket costs. Expenses covered by the sponsors include the costs of medications, testing, doctor visits, and other research costs.  

In addition, the Affordable Care Act (ACA) requires insurance companies to provide routine care to people in clinical studies that they would generally have if they were not enrolled in the study.

Phases of Clinical Trials

Clinical trials are conducted in four phases, and each phase has a different purpose.

In phase 1, researchers will test a drug or treatment on a small group of people for the first time over a few months. Before this phase, the drug is tested using lab experiments and then on animal subjects. In phase 1, the purpose is to study the treatment and learn about its safety (including side effects) and dosage.

Phase 2 trials involve large groups, up to several hundred people. The purpose is to determine the effectiveness and better understand side effects. Phase 2 can last from several months up to two years.

In phase 3, the drug or treatment is given to up to 3,000 people to confirm effectiveness, monitor side effects, and compare it to similar therapies. This phase can last from one to four years.  

Phase 4 occurs after FDA approval and the drug is made available to the public. In this phase, researchers track its safety in the general population and seek out more information about its benefits and uses.

If You Don't Qualify

If you have applied for a trial and didn't qualify, that's OK. The main reason you probably were not approved was related to health and safety protocols. Clinical trials will follow strict guidelines approved and monitored by the FDA before a drug or treatment strategy is available to the general public.

Study criteria lists are specific to who can be included and who should be excluded. Also, criteria might get modified with each trial phase based on research findings.

In general, researchers want volunteers who can benefit from the studied drug based on age, sex, or stage of illness. The study might exclude people with other preexisting conditions and those who take medicines that might affect the study treatment or protocol.

What this all means is that study participants need to be shielded from risks. So, don't be discouraged if you don't qualify. It just means you did not meet the criteria for one clinical study, not every single one.

You might have other options for a clinical trial. Your rheumatologist can be a helpful resource for finding one that might best fit your unique situation. In addition, new therapies are being approved regularly to treat RA so, if you don't have options today, that might change in a few months' time.

Summary

Rheumatoid arthritis is a lifelong condition that requires long-term treatment. If you live with severe RA or cannot afford expensive treatments, a clinical trial might be an option. Even with mild to moderate RA, you can still enter a research study to help researchers learn more about the condition, leading to newer, more advanced treatments.

The FDA heavily regulates clinical trials with patient safety at the forefront. They work with researchers, healthcare providers, and a review board to ensure that any risks are reasonable compared to the benefits of a study. If you experience side effects or discomfort, you can quit the study. You can leave a study at any time for any reason.  

A Word From Verywell

If you are interested in joining a rheumatoid arthritis clinical trial, talk to your healthcare provider. They can answer any questions you have and give you information about clinical trials that might help you.

Your healthcare provider might also know about a study treatment’s potential risks and benefits. They can also continue answering questions and clarifying aspects of a clinical trial once you have joined.