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8 Facts To Know About Psoriatic Arthritis Clinical Trials

Medically reviewed by Florentina Negoi, M.D.
Posted on February 20, 2024

There are more treatment options for psoriatic arthritis (PsA) now than ever. But before each new treatment became available, it was first studied and used in a clinical trial.

A clinical trial is a research study in which human volunteers help researchers learn more about how to prevent, diagnose, or treat a disease like psoriatic arthritis. You may be interested in joining a clinical trial to get the latest treatment, become involved in the research, or give back to the PsA community.

Before you join a clinical trial for PsA, here are eight things you should know.

1. New Treatments Are First Tested on Healthy Volunteers

Clinical trials are conducted in four phases. If you have psoriatic arthritis and join a clinical trial, you’re likely joining in phase 2, 3, or 4. Below is a summary of the phases of a clinical trial:

  • In phase 1, a new drug or treatment is given to a small group of people — generally, 20 to 100 participants — to learn about its safety and side effects. Usually, this initial phase involves healthy volunteers.
  • Phase 2 studies aim to find out if the new treatment can improve a health condition. This phase involves a larger group of people — usually 100 to 300. Including more people gives researchers a better chance of recognizing any side effects of the new treatment.
  • Phase 3 clinical trials collect information about how effective and well tolerated the new treatment is in a much larger group, up to several thousand people. When the study is complete, the U.S. Food and Drug Administration (FDA) will decide whether to approve the treatment.
  • Phase 4 clinical trials take place after FDA approval so that researchers can study how a treatment works when people take it under real-world conditions and not in a controlled trial.

2. Strict Guidelines Determine Who May Participate

It’s possible that you won’t be selected to participate in a clinical trial because you’re not eligible. Studies have eligibility criteria to help determine who should be included in the trial.

It’s important to have a diverse group of people involved in clinical trials because different people can experience the same disease in different ways. The eligibility criteria help researchers make sure that they have information about how a treatment affects different groups. People of color are especially underrepresented in clinical trials.

Eligibility criteria to participate in a clinical trial for psoriatic arthritis may include factors such as your:

  • Age
  • Weight and body mass index (BMI)
  • Race or ethnicity
  • Gender
  • PsA symptoms
  • Disease activity
  • Past treatments for psoriasis or PsA

The criteria may also consider whether you are pregnant or have other medical conditions, such as cancer or another autoimmune disease.

Researchers may also evaluate the severity of your PsA before enrolling you. Your doctor may use a tool such as the Psoriatic Arthritis Disease Activity Score or the Disease Activity Index for Psoriatic Arthritis. They may also consider which joints are affected, whether you have nail problems, and if you have any related conditions.

3. You Must Give Informed Consent To Participate

The amount of risk involved in a clinical trial depends on the study and the type of treatment tested. Risks include the time involved, discomfort, and adverse events (side effects) of the treatment.

An institutional review board (IRB) makes sure the potential benefits outweigh any potential risks of a clinical trial. The IRB reviews the research and evaluates risks before and during the study to protect participants’ safety.

You can learn about the potential risks of the clinical trial before you enroll through a process called informed consent. This process gives you a chance to learn about the purpose of the study and any possible benefits and risks.

The research staff will provide you with written information about the study that you must read and sign before participating. They should help you understand all the details and give you plenty of time to decide whether you want to participate.

Even if you sign the informed consent documents, you can withdraw for any reason before or during the study.

4. You Might Receive a Placebo

A MyPsoriasisTeam member reminded others, “Remember, if you participate in a clinical trial, there’s a chance you might get the placebo medication.”

There are different types of clinical trials, depending on the study’s goals. Some standard design elements help scientists show that a new treatment is safe and effective.

One method is to compare the treatment being studied to a placebo. A placebo is designed to look just like the new treatment but without any active properties. Studies that use placebos are known as placebo-controlled studies.

If you participate in a clinical trial, you won’t know if you have the active treatment or placebo because most studies are double-blind, which means that neither you nor the researchers know what treatment you received. Double-blind studies are randomized, so you will be randomly selected to be part of either the active intervention or placebo intervention group.

5. Participating in a Clinical Trial Can Be Rewarding

About 40 percent of people with psoriatic arthritis don’t have a good response to available treatments. By participating in a clinical trial, you have an opportunity to take an active role in your health care and help others with PsA get better treatment options in the future. This alone can be a rewarding experience.

Many clinical trials also offer compensation in the form of cash, time and travel reimbursement, and free medical care.

6. Clinical Research Can Help Doctors Better Diagnose Psoriatic Arthritis

It’s estimated that up to half of people with psoriatic arthritis are undiagnosed. Permanent joint damage can happen in the first few years of developing the condition. According to the International Journal of Molecular Sciences, about half of people diagnosed with PsA have evidence of joint damage after having the disease for about two years. A delay in diagnosis of just six months can lead to worse outcomes.

Clinical research can help researchers learn how to recognize the risk factors for psoriatic arthritis and understand how PsA progresses. Prompt diagnosis and treatment can help lead to better outcomes.

7. Clinical Trials Can Lead to New Treatments for Psoriatic Arthritis

Clinical trials help researchers learn more about what causes psoriasis and psoriatic arthritis. As researchers gain a better understanding of how and why PsA develops, they can develop new and more effective treatments.

Several new treatments for PsA are biologics, which target a specific part of the immune system. Biologics are classified based on their target. New PsA treatments may aim at different parts of the immune system or use new combinations of drugs.

PsA treatments have made many advances in recent years. Even so, some gaps in treatment remain. Areas that researchers may continue focusing on include:

  • Biologics that resist losing effectiveness over time
  • Nonsteroidal topical creams and ointments
  • Comparisons of psoriatic treatments to see which is more effective
  • Long-term safety of new treatments
  • Effects of treatments on quality of life
  • More acceptable ways of taking medications, such as pills instead of injections
  • Choosing the best treatment based on psoriatic arthritis symptoms

8. You Can Search for Clinical Trials To Join

If you’re looking for a clinical trial for psoriatic arthritis, try contacting local dermatology offices and ask if they’re participating in any clinical studies that you may qualify for.

You can also search for clinical trials on ClinicalTrials.gov or with the National Psoriasis Foundation’s online clinical trial finder.

Talk With Others Who Understand

MyPsoriasisTeam is the social network for people with psoriasis and their loved ones. On MyPsoriasisTeam, more than 125,000 members come together to ask questions, give advice, and share their stories with others who understand life with psoriasis.

Have you participated in a clinical trial for psoriatic arthritis? Share your experience in the comments below, or start a conversation by posting on your Activities page.

    Posted on February 20, 2024
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    Florentina Negoi, M.D. attended the Carol Davila University of Medicine and Pharmacy in Bucharest, Romania, and is currently enrolled in a rheumatology training program at St. Mary Clinical Hospital. Learn more about her here.
    Amanda Jacot, PharmD earned a Bachelor of Science in biology from the University of Texas at Austin in 2009 and a Doctor of Pharmacy from the University of Texas College of Pharmacy in 2014. Learn more about her here.

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