Clinical Trials for Ankylosing Spondylitis: What to Know

Medically Reviewed by Tyler Wheeler, MD on August 02, 2022
Written by Marijke Vroomen Durning, RN
5 min read

If you have a chronic illness like ankylosing spondylitis and don't get relief from traditional treatments, a clinical trial might be the next logical step. Researchers around the country are working to find effective treatments to help people like you manage the pain and slow down the progression of this disease, a rare type of arthritis that causes pain and stiffness in your spine. But they need help from volunteers to be part of clinical trials. Some trials look at new or different drugs to treat the disease, while others look at specific actions you can take to live with your condition, such as Pilates and yoga.

Many benefits go with participating in an ankylosing spondylitis clinical trial, but trials aren’t always a good fit for everyone. You may leave the trial, for any reason. You don’t have to say why, although it does help if the researchers do know the reason. For example, if you leave because you can’t tolerate the side effects or the treatments take too long, this is helpful information for the team.

If you’re interested in learning about clinical trials, ask your doctors if they know about any studies that might be a good fit. Clinical trials may have specific requirements for participants, like they may require that you’ve had the disease for a certain number of years or that you’ve already tried certain types of treatment. They may also have some exclusion criteria. For example, one trial may say that you cannot participate if you have other health issues or you are over a certain age, while another doesn’t have those restrictions.

Several positive things can come from participating in a clinical trial for ankylosing spondylitis. The most obvious one is that you could have access to a new or improved treatment that is not yet available to the general public. But there are other advantages too. They include:

  • Close follow-ups from the trial staff
  • Being an active part of your health care team
  • Having access to more information about your health condition
  • Possible payment for your time
  • Your participation may benefit other people in the future

As much as there are benefits, there are some possible disadvantages to being in a clinical trial. They include:

  • More clinic or office appointments and tests than someone who is not in a trial
  • Possible out-of-pocket costs for travel, supplies, etc.
  • If it is a trial that uses placebos or a possibly less effective treatment, you may not get the study drug
  • Possible side effects from the treatment
  • The trial may be stopped early for a variety of reasons, such as a high number of participants having serious side effects or not enough people were recruited to be part of the study.

Choosing to participate in a clinical trial is a personal decision that you need to be comfortable with. Before you agree, someone from the team will explain to you the details of the study. This is the time to ask as many questions as you have about the trial to ensure you are comfortable with the process.

Here are some questions you might ask:

  • What is being tested?
  • What phase is the trial?
  • Are they still recruiting and might I qualify?
  • How long is the trial?
  • When will the results be shared?
  • Are there other trials that might be better for me?
  • What are the benefits and risks of this particular trial?
  • Where is the trial taking place?
  • Will I have to stay in a hospital or clinic during the treatment? If not, how often will I have to go to the office/clinic for treatments and evaluations?
  • Will I be reimbursed for any expenses?
  • Who will be my primary contact if I become ill? My usual doctor or someone with the trial?
  • Who can I contact for more information?

Once you understand the procedure and what will happen, you are asked to sign the form that states you understood the risks and benefits of the trial. It’s important to remember that this is not a contract and you may stop participating at any time, for any reason.

Your doctor may be able to refer you to a trial, but you can also find clinical trials on your own, reaching out to the trial or study coordinator for more information. You can learn if you might qualify for the trial and you can ask questions about the trial itself, the goal, and more. If you do find a trial that interests you, be sure to speak with your doctor and provide the information so your care team knows what you are doing and what they might be expected to do.

Clinical trials are divided into different phases, according to how far along the research is.

Phase I studies involve a small group, usually of healthy adults, to test if a candidate drug or treatment is safe. The study participants receive low doses of the treatment to check for safety issues. A phase I trial can last up to several months and is the first study phase to involve humans.

Phase II studies use a larger group of people who have the target condition and the study can last up to 2 years. The researchers look for possible side effects and how effective the treatment is. Although not common, some treatments can get accelerated approval for use after a phase II trial if the drug treats a serious illness that has no other alternatives.

Phase III studies are the larger trials that can involve thousands of people with a specific illness or condition. The studies can last between 1 to 4 years. Good results of a phase III study can be used to submit applications to the FDA for drug approval.

Phase IV studies are done after treatment is already approved by the FDA and involve several thousand volunteers. Researchers use phase IV studies to learn how the treatments affect patients over a longer period.