What to Know About Ankylosing Spondylitis Clinical Trials

Progress has been made in treating ankylosing spondylitis (AS) thanks to research breakthroughs achieved through clinical trials. In addition, new medications, therapies, and treatment strategies have revolutionized the management of AS and improved people's lives.

For people living with AS, clinical trials offer the opportunity to try promising new treatments and different approaches to using existing therapies before they become available to the general public. 

This article discusses what you need to know about ankylosing spondylitis clinical trials, including their efficacy and safety, potential benefits and risks, and how to find and enroll in an ankylosing spondylitis clinical trial. 

Ankylosing Spondylitis Clinical Trial Basics

Clinical trials are research studies that evaluate the safety and effectiveness of interventions for a specific disease or health condition. Through clinical trials, researchers and healthcare providers learn if a new treatment—such as a medicine, device, surgical procedure, type of exercise, or diet—is effective for people with the condition.

Clinical trials using human volunteers (participants) are essential to testing new treatments. Volunteers with specific conditions can access promising treatments before they become widely available. They also help investigators and healthcare providers make advancements in diagnosing, treating, and managing ankylosing spondylitis.

In the last decade, researchers have made incredible discoveries that have led to more and better treatment options for people with ankylosing spondylitis. In the past, treatment options for people with AS were limited to nonsteroidal anti-inflammatory drugs (NSAIDs) and tumor necrosis factor (TNF) inhibitors. Though these therapies effectively reduce pain and stiffness for many people with AS, they don’t work for everyone.

Research breakthroughs have led to the discovery of new medicines that not only help manage AS symptoms but also slow the progression of the disease to prevent joint damage and other complications.

Phases of Clinical Trials

Before any new treatment can be prescribed, it must undergo rigorous testing to ensure it is safe and effective. Much of this testing occurs during clinical trials, which are conducted in phases.

Each phase is designed to help researchers collect data to understand how the treatment works. Once researchers have enough evidence that a treatment is safe and effective for its intended use, they can apply for approval from the U.S. Food and Drug Administration (FDA).

Clinical trial phases include:

• Phase I trials: The new drug or treatment is tested on a small group of people (20 to 80). This phase helps researchers learn how the medicine or therapy works, evaluate its safety and determine the most effective dose. 
• Phase II trials: The new drug or treatment is given up to several hundred people to further study its effectiveness. In addition, researchers will monitor participants closely to gather more data on side effects to ensure the new treatment is used safely.
• Phase III trials: The new drug or treatment is given to 300 to 3,000 people to confirm its effectiveness and monitor side effects. In this phase, the new treatment may be compared to standard or similar treatments to see if it works better.
• Phase IV trials: After the FDA approves a new drug or treatment, it is available to the public. Researchers will continue to gather information about the treatment’s long-term safety, effectiveness, and optimal use.  

Eligibility

Every clinical trial has its own eligibility criteria. These are requirements you must meet to join the study. Measures may include age, sex, the severity of AS, treatment history, and other medical conditions. Eligibility criteria help researchers ensure that new treatments are tested on similar groups of people so that results will be as accurate as possible.

They also help keep study participants safe. For example, people with multiple chronic conditions, those who take certain medications, and pregnant people are often excluded from clinical trials due to safety concerns. 

Protocols and Review Boards

Every clinical investigation is conducted according to a protocol (plan). The protocol is a document that outlines details of the research study, including rationale, objectives, methodology, recruiting guidelines, and data collection methods. 

Clinical trial protocols include:

• The drug or treatment being tested 
• How the drug or treatment will be given to participants, and at what dosage(s) 
• How many people will be recruited for the study 
• Eligibility criteria for study participants 
• List and schedule of assessments, including tests, procedures, and what data will be collected 
• Length of the study
• Whether there will be a control group and other methods to limit research bias 
• How the data will be collected, reviewed, and analyzed 

Once the protocol is completed, it is reviewed by an Institutional Review Board (IRB). The board is comprised of a group of specialists from different scientific fields who review research protocols and monitor clinical trials. IRBs are designed to protect the rights and welfare of clinical trial participants. The IRB can approve, request modifications to, or disapprove research studies. 

Finding a Clinical Trial

Talk with your healthcare provider if you want to join an ankylosing spondylitis clinical trial. They can help determine whether this is a good option for you and help find clinical trials you may be eligible for.

Clinical trial databases online allow you to search for research trials actively recruiting volunteers. You can search by location, symptoms, and treatments being tested.

Benefits of Participating in a Clinical Trial

Research advancements have led to new ankylosing spondylitis treatments that have improved the lives of those living with the condition. As more novel therapies are discovered, volunteers are needed to continue to make effective treatments for AS.

There are many benefits to participating in a clinical trial, including the following:

• You may have the opportunity to try a new treatment before it is available to everyone. 
• You become an active participant in your health care.
• You will receive more hands-on medical care and frequent health check-ups from researchers and healthcare providers.
• All study-related medical care, lab tests, and medications will be provided to you at no charge.
• You have the chance to advance medical knowledge and make a difference in the lives of current and future people living with AS.

Potential Downsides of Joining a Trial

Potential risks and downsides of joining a clinical trial include:

• You may experience side effects from the new drug that are unknown before joining the trial. 
• The new treatment may not work as intended or be better than the standard treatment. 
• The standard treatment is compared to the new treatment in a randomized clinical trial. Study participants do not get to choose whether they receive the new therapy being tested or standard treatment.
• You may be required to travel to the study site a few times a week. However, more frequent medical appointments and tests (e.g., imaging scans, lab tests) during the clinical trial will require a time investment and commitment. 

Is a Clinical Trial the Right Choice for You?

Talk to your rheumatologist or primary healthcare provider if you are interested in participating in an ankylosing spondylitis clinical trial. They can help determine if a clinical trial may benefit you, answer your questions, and give you information about trials you may qualify for.  

If you join a trial and decide you no longer want to participate, you can leave the study for any reason at any time. This includes if you feel uncomfortable with the side effects or if you feel like the new treatment isn’t working for you. Many rheumatology studies provide treatment to people whose conditions do not improve, sometimes even before the study ends.

Summary

There is no cure for ankylosing spondylitis, but recent advances in biotechnology, immunology, and pharmaceutical science have opened up new possibilities for AS treatment approaches. Researchers are currently exploring new medicines and treatment approaches for AS, and clinical trials to test the safety and effectiveness of these treatments are essential. 

Joining a clinical trial can allow you to try new and potentially more effective treatments. You may also have access to treatment that you would otherwise not be able to get, along with more frequent medical care and attention from healthcare providers and researchers.

Clinical trial participation requires a time commitment, and you may experience side effects from the tested treatment. Clinical trials are strictly regulated and closely monitored to ensure the safety of volunteer participants. Before joining a clinical trial, discuss the potential benefits and risks with your healthcare provider. 

A Word From Verywell 

If you decide to participate in a clinical trial, you may have access to treatments that are more effective than standard treatments. You will also contribute to advancing medical knowledge of AS, giving hope to people living with this chronic and sometimes disabling disease.