Managing Lupus Symptoms During a Clinical Trial

Joining a lupus clinical trial is a big decision, and one of many factors to consider is how it could impact your lupus symptoms. Living with lupus often involves trial and error with treatments and managing unpredictable symptoms.

If you enter a clinical trial feeling informed, prepared, and empowered, it might offer a unique opportunity to learn more about your individual experience with lupus. Plus, you’ll have a team of researchers available to help address any symptoms or concerns that arise during the trial.

Here’s what you need to know about how clinical trials might affect your lupus symptoms, how to manage those symptoms during the trial, and tips for staying in touch with researchers and your health care team.

How Clinical Trials May Affect Your Lupus Symptoms

Participating in a clinical trial may offer access to potential new treatments that could help manage your lupus symptoms, especially if other therapies haven’t worked for you. Additionally, your participation contributes to research that could lead to better treatments for many lupus patients in the future.

However, it’s important to be aware that clinical trials may also be viewed as complicated due to “the uncertainty of clinical response, expected or unexpected side effects, and so forth,” says Gaurav Gulati, MD, Senior Medical Director and Director of Rheumatology Clinical Trials at UC Davis Health.

You can prepare for this by closely researching what the clinical trial will entail before you sign up. The study design of the trial will typically define what you’re allowed (or not allowed) to do or use during your participation, including other medications. This could also include preventive measures.

Plus, it will define what options are available if you experience unexpected flares or side effects. “Discuss this with the principal investigator before making a final decision on the trial,” says Dr. Gulati.

You should also clearly understand if the trial will involve a placebo (a non-active pill that looks like the study medication), or if you’ll know for certain that you’re taking a certain study treatment. “For me, the fact that I knew what medication I would be on — and that I would be on medication in general — was comforting and reassuring,” says lupus patient Rekha Sreedhara, who was involved in a lupus clinical trial in 2019.

Consider if you’re comfortable participating in a trial that may involve temporarily stopping your current medication to receive the study medication or placebo. These decisions will be  based on your current health status and your doctor’s recommendations. Details of any clinical trial should be discussed with your primary care physician.

“That is always something I question,” says Sreedhara. “It’s about weighing the pros and cons of whether it is worth participating in a trial, based on where my health is currently.”

How to Manage Symptoms During Your Clinical Trial

You may find that you have more attention put on your symptoms than ever before when you participate in a clinical trial, something many lupus patients find helpful.

“My sister Juana has lupus and has been in clinical trials,” says Estela Mata-Carcamo, a health care advocate and president of the nonprofit organization Looms4Lupus, which she founded with her sisters. “She’s talked about how pampered she felt, because if you have any new issue, the researchers will see you immediately and also work with your provider.”

An important part of a clinical trial is keeping track of your symptoms, so your research team and provider can know exactly what you’re experiencing and when.

“We encourage patients to keep diaries for what their symptoms are,” says lupus researcher Philip J. Mease, MD, director of rheumatology research at Swedish Health Services. “When they come in for their visits, they report any and all kinds of symptoms that have occurred — either ones that they feel are related to their disease process or those that seem unrelated.”

For Sreedhara, who used a cream twice per day as part of her clinical trial, this close monitoring involved creating a slideshow presentation to track her progress.

“I took a picture every single day of the spots on my face and back, then created a deck where I could upload the pictures and include the date and time of when I took them,” says Sreedhara. “That way, the doctor knew exactly what those changes were over time.”

Close monitoring of symptoms allowed Sreedhara and her health care team to notice changes in color and size of lupus skin symptoms.

However, this ongoing symptom tracking and communication with the researchers and your provider isn’t just about determining how well a treatment is working. “Staying in touch and regular assessments is also very important for monitoring for side effects and any other issues,” says Dr. Gulati. “It’s an opportunity to bring up any concerns or questions you might have.”

For instance, one of the challenges that patients may face is managing lupus flares during a clinical trial. Clear communication with your research team and physician can help you navigate this throughout the study.

“Most clinical trial protocols have guidance regarding what medications are preferred for treatment of a lupus flare during the clinical trial,” says Saira Z. Sheikh, MD, Professor of Medicine in Rheumatology, Allergy, and Immunology at The University of North Carolina at Chapel Hill. “In these situations, it is best to reach out to your clinical trials research team to help you navigate how to manage your symptoms during the trial.”

No two people have the same “type” of lupus, meaning that every patient’s journey and experience is unique.

“Always remember that your health is the top priority in a clinical trial, so your research team will always try to prioritize your well-being and what is best for you,” says Dr. Sheikh.

Ways to Communicate with Your Health Care Team

At the start of the trial, your research team will tell you the best ways to communicate with them. That may involve emails, phone calls, or using a message portal. Any changes in symptoms or other updates are extremely valuable to both you and your research team, so always reach out if something feels new, different, or confusing.

“One of the advantages of being in a clinical trial is that patients have direct access to their research team,” says Dr. Sheikh. “Your symptoms are so closely monitored, both during research visits for the clinical trial, as well as in-between visits. Know that your research team is interested in knowing how you are feeling at all times.”

And if a concerning symptom does crop up, know that the team is there to support you. “Patients should rest assured that clinicians are going to listen to any cry for help,” says Dr. Mease. “They will respond and won’t let it keep going.”

To that point, if a clinical trial isn’t working out for you, whether it’s due to intolerable symptoms or because you’re finding the commitment to be too difficult, if you decide not to continue with it. You may still be asked to come in for one final visit.

“Patients should never feel remiss about dropping out of a study,” says Dr. Mease. “That becomes part of the evidence base for a study drug being worked on. The fewer people who drop out, that’s part of the evidence for benefit — and they shouldn’t feel like they’re disappointing their physician if they make that decision.”

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