How to Prepare for Lupus Clinical Trials

Participating in a lupus clinical trial can be a valuable option if you’re living with this chronic autoimmune disease. These trials often provide access to potential new treatments that aren’t yet widely available. However, it’s understandable to have concerns, as clinical trials are sometimes surrounded by misconceptions, myths, and uncertainties.

This is especially true since information on new treatments can be limited, particularly for groups like BIPOC patients. But with the right preparation — both logistically and mentally — you can feel more confident in exploring, considering, and potentially joining, a clinical trial.

Understanding Lupus Clinical Trials

A lupus clinical trial focuses on finding potential treatment options for patients, while studying the benefits, efficacy, and side effects of different study drugs.

“Lupus trials can come in many different flavors,” says rheumatologist Kiran Farheen, MD, who is also a principal investigator and sub-investigator for clinical trials. “Just like the disease is different, trials are studying different potential treatments for different indications.”

For example, someone with systemic lupus erythematosus (SLE) will need a different intervention or treatment than someone with severe, refractory lupus. And not all clinical trials are treatment based: Some may also look at quality of life, the influence of lifestyle changes, and other factors that influence lupus.

Clinical trials can offer valuable opportunities for patients who choose to participate. For Emmitt Henderson III, CEO of the nonprofit Male Lupus Warriors, a clinical trial played a key role in improving his condition when it was at its worst.

“I was going into the hospital almost every month for a week and a half for flares and resulting internal organ failures,” says Henderson. “My heart took a lot of damage and my primary rheumatologist told me that it might not sustain another flare if that happens.”

His rheumatologist then informed him about a clinical trial for lupus, suggesting that he could be a potential candidate. The trial involved a bone marrow stem cell transplant and chemotherapy.

“It saved my life,” says Henderson. “After that clinical trial, I didn’t see an emergency room for almost half a year. Even though the lupus was still there and showing me certain signs, it was very mild and tolerable.”

Although Emmitt did see improvement from his participation in the clinical trial, that is not the case for everyone.

Navigating the Informed Consent Process

The informed consent process is a required (and important) part of clinical trials to ensure you understand what the trial entails. This form reviews the purpose, procedures, risks, and benefits of the study. You will be given ample time to read through the ICF, ask questions to the study staff, and even take it home and think about it or review it with your loved ones.

“It includes the time commitment, if any compensation benefits are present for the participants, any known adverse effects, and if there is a blood draw involved,” says Dr. Farheen. “It goes over details of what you should know before you sign up for a trial.”

This information may be exchanged via face-to-face contact, mail, telephone, or other mediums, but usually it’s documented using a written document that includes key information about the research, per the U.S. Department of Health and Human Services.

You will be given the opportunity to ask questions and seek clarification — and you should also be in the position to freely decide whether to enroll or withdraw in the research during this time. Participating in a clinical trial is voluntary.

The paperwork can admittedly be confusing or filled with medical jargon, so it’s important to advocate for yourself by truly getting to the bottom of what the terminology and study descriptions mean. “It was a little overwhelming because of the medical terms they were using that I wasn’t familiar with,” admits Henderson, who did his own research to translate the medical jargon.

You should fully understand the common known and rare side effects involved with the study treatment you may be receiving, how your patient data will be protected and used, the impact the trial will have on your everyday life beyond just study visits (i.e. daily medication logs, dietary restrictions, and so forth), and success rates of similar trials in the past.

Key Considerations Before Enrolling

The informed consent process will also help you evaluate if the clinical trial is right for you, which you should discuss with your doctor and loved ones.

“It’s important to get informed and get as much information as possible, which goes for any clinical trial,” says Estela Mata-Carcamo, a health care advocate and president of the nonprofit organization Looms4Lupus.

Mata-Carcamo recommends considering the following factors:

• Are you a good candidate for the study?
• Do you qualify for the study?
• How long will the study last?
• Does it include any study treatment?
• How long are the visits?
• How many times do you have to go in to see your provider?
• Will you know whether the study medication or study treatment is being given to you?
• What questions should you ask regarding the consent forms?
• What is required of you as a participant in the study?
• Will you be compensated for participating in the study?
• Will you be reimbursed for any travel expenses or other costs related to the study?

Henderson needed to carefully consider the demands of his clinical trial and the lengthy procedures. His clinical trial involved staying in the hospital for a total of three days, followed by a month and a half of experiencing paresis (partial loss of voluntary movement or impaired muscle function), plus follow-ups.

He also struggled with determining whether the trial was right for him based on his race. “I am mixed race, Asian and Black, so there was nothing letting me know whether it was for my ethnicity,” says Henderson. “But at the same time, I trusted my doctor, and she recommended it.”

Henderson adds that, knowing what he knows now, he would want to understand if the trial had been done on people of his race, gender, and age. “It would give me a little sense of knowing that I’m not the only man or person of color that’s going through this, for instance,” says Henderson.

Not all providers will have information about the clinical trials if they’re not the ones conducting them — and not all providers will inform you that there are options for trying potential treatments such as clinical trials. “Don’t wait for your doctor to tell you about a clinical trial. Do your own research. Be proactive with your health,” says Henderson.

The number of clinical trials being conducted in the United States and around the world is higher than ever before. Many of these studies are registered with ClinicalTrials.gov, one of the largest databases of clinical trials in existence, as well as on the National Institutes of Health (NIH) website. Search Clinical Trials is a free resource that helps individuals find trials that match their medical and healthcare needs.

In addition, you can explore searchable trial listings at local health care centers, universities, on websites of disease-specific organizations, pharmaceutical company websites, and sometimes even in local newspapers.

Mata-Carcamo says her organization, Looms4Lupus, use social media to spread awareness about onoging clinical trials, ensuring that more patients are informed and can advocate for themselves when considering clinical trial participation.

What to Expect During Your Clinical Trial

First, you’ll have an initial consultation. A little preparation can go a long way in making this visit go smoothly. “Make sure you have enough time blocked out so you don’t get stressed,” says Dr. Farheen. “Bring all your medications and prior records for this visit.”

During this first visit, the researchers may conduct physical tests to gather baseline data.  This will vary from study to study. Certain trials testing medication may assign you randomly to either a study treatment group or control group. In other cases, you’ll know if you’re receiving a certain medication.

Make sure you ask questions and understand the procedures and expectations of the trial. As a next step, you’ll follow the trial procedures and will have the opportunity to report any issues or concerns to the researchers.

What you should expect during the course of the trial in terms of visits, procedures, and tests varies depending on the trial, so it’s important to make sure you understand this before signing the consent form, says Dr. Farheen.

During regularly scheduled visits, the research staff will conduct evaluations, collect data, and monitor your safety and well-being. You should also continue to see your regular care team for routine health care throughout the study.

The trial design will also depend on its phase. The U.S. Food and Drug Administration usually requires Phase 1, 2, and 3 trials before approving a treatment for further use. Each of these trial phases has a different purpose:

• Phase 1 trials test an experimental treatment on a small patient population (around 20 to 80) to evaluate its safety and dosage.
• Phase 2 trials involve a larger group of patients (around 100 to 300) to determine the treatment’s efficacy, while continuing to monitor safety.
• Phase 3 trials gather more information from a few hundred to a few thousand patients to study different populations and different dosages, while comparing the treatment with other approaches. If the trial results support the treatment’s use for a particular condition, the FDA will approve it.

Once a clinical trial ends, the researchers will analyze the collected data to determine the meaning of the results and next steps. Before the study starts, you should be given information on how long the study will last, whether you’ll continue receiving treatment after the end of the trial, and how the research results will be shared.

“There definitely has to be a follow-up plan, which I’m sure there is nowadays,” says Henderson. “That is what the patient needs to know and understand from the beginning.”

Finding Support Systems and Resources

Recruit your network of family and friends for support during a clinical trial, or tap into additional resources or patient advocacy groups.

This may involve preparing for logistics like transportation or guest visits to help provide support and if needed, care for your mental health during your trial. Henderson, for instance, asked a friend to drop him off at the hospital for his clinical trial — and his family and friends visited him while he was there.

“My support system wasn’t there to ask me how the procedure went,” says Henderson. “Instead, they were talking to me, making me laugh, and playing cards with me, which is what I needed.”  Each person will have different needs, which is why it is important to let your family and friends know what kind of support is needed.

You can also ask the clinical team what resources are available for support. Common resources include patient advocacy organizations like the Global Healthy Living Foundation and the Lupus Foundation of America, support lines (for instance, Henderson recommends resources like California’s 211 line, a free and confidential phone number that connects you to local community services), or even social media groups.

“With social media, you can find certain support groups for your illness,” says Henderson. “But you have to be proactive, because they’re not going to knock at your door when you have that diagnosis. You have to go look for it, listen again to the patients themselves, and then ask questions.”

With the right planning and support systems, you can feel confident in your decision to enter a lupus clinical trial. In turn, your participation may benefit both your own disease management and create more opportunities for other patients to get the best treatment.

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This article was made possible with support from Bristol Myers Squibb.