Clinical Trials and Sjögren's Disease

About Clinical Trials

Clinical trials are an important step in the process for developing new medicines — and the Sjögren’s Foundation is proud to support clinical trials in the United States that are working to develop a medicine to treat Sjögren’s disease.  

Looking for a clinical trial for Sjögren’s disease?

• Find a clinical trial close to you using our clinical trial map or state listings
• Learn more about Sjögren’s Foundation Corporate Members that are sponsoring active clinical trials
• Visit ClinicalTrials.gov to view all Sjögren’s disease clinical trials

As a Sjögren’s patient, you may have the opportunity to participate in a clinical trial. The choice about whether to participate in clinical research is deeply personal, and it’s important to understand the benefits and risks. Here’s what you need to know. 

What Are Clinical Trials?

Clinical trials are a type of medical research. They help researchers gather information about the safety and effectiveness of new medical treatments, such as:

• Medicines
• Medical devices
• Procedures (including surgeries)

In clinical trials, volunteers agree to try a new medical treatment. Researchers then monitor how the treatment affects the people in the clinical trial — including whether the treatment improves participants’ health and is safe. 

Why Do Clinical Trials Matter? 

Clinical trials help to drive science forward. They help researchers learn and test new treatments to find out if they’re safe and effective.  

What’s more, clinical trials are an important and required step in getting new medical treatments to the market. The U.S. Food and Drug Administration (FDA) requires clinical trial research as part of its approval process for any new drug or device.

When clinical trials show that a treatment is safe and effective, it increases the chances that that treatment will be approved by the FDA and will be made available to other people. 

Why Are Clinical Trials Particularly Important For Sjögren’s Disease?

There are currently no FDA-approved medicines designed to treat Sjögren’s specifically. More clinical trials — and more clinical trial participants — are needed to make a medicine for Sjögren’s disease a reality. 

Clinical Trial Phases

Before clinical trials can begin, new medicines need to meet certain criteria for safety before they can be tested on humans. Researchers also need to gather some information about the type of effect the medicine has on the body. This testing usually happens by studying how the treatment affects animals.

Once these safety criteria are met, the new medicine can move on to clinical trials.

Clinical trials progress through 4 phases.

Phase 1

Phase 1 clinical trials are the first time a new medicine or other treatment is tested in humans. These trials usually involve a small number of participants — usually between 20 and 100 people.

The goal of phase 1 trials is to understand how the human body handles a medicine — like how long it stays in the body before it’s metabolized (broken down) and eliminated as waste.

During phase 1 trials, researchers also watch for adverse (negative) effects that the treatment may cause.

Phase 2

Phase 2 clinical trials involve up to a few hundred participants who have the disease or health condition the medicine is designed to treat. In this phase, researchers assess how effective a medicine is, record side effects that participants experience, and determine the ideal dose of the medicine.

About 1 in 3 medicines progress from phase 2 to phase 3.

Phase 3

In phase 3 clinical trials, a larger number of participants (from 200 to more than 3,000 people) try the new medicine. Researchers gather information about the medicine’s safety and effectiveness at treating the health condition or disease.

After phase 3, the FDA determines whether to approve the new medicine. Of every 100 treatments tested in phase 3 clinical trials, about 25 to 30 are approved.  

Phase 4

Phase 4 clinical trials usually take place after a new medicine or other treatment is approved by the FDA. Continuing to test the safety of the medicine over a longer period of time through phase 4 clinical trials is usually a condition of getting FDA approval.

Phase 4 clinical trials are large programs that include several thousand participants.  

How do clinical trials work?

To begin clinical trials, researchers first recruit a certain number of volunteers who meet the trial’s eligibility criteria. These criteria lay out who can and can’t participate in the trial.

They may include things like:

• Age
• Sex
• Disease diagnosis – whether you have the disease the medicine is designed to treat based on specific testing criteria
• Disease status – such as length of time you have had the disease or a specific symptom or disease presentation.
• Other aspects of your health history, like if you have certain other health conditions
• Your location – for example, if you live close enough to attend check-ups related to the clinical trial design.

The number of participants needed for the trial depends on which clinical trial phase the medicine is in.

Volunteers who meet the eligibility criteria must review and sign an informed consent document to join the clinical trial. The informed consent document is an important document that:

• Provides information about the clinical trial
• Explains the risks (possible harms) of participating
• Sets rules for the clinical trial  

By signing an informed consent document, volunteers are saying that they understand the risks and agree to follow the rules.

The informed consent document will also explain what participants will need to do as part of the clinical trial. For example, participants might need to take pills, get exams, or get blood tests. 

Will I Definitely Get To Try The New Medicine If I Participate In A Clinical Trial? 

You don’t always get to try the new medicine or treatment when you participate in a clinical trial. Depending on the clinical trial and the phase, participants may be assigned to groups:  

Participants in a treatment group get the new treatment or medicine that’s being studied 

Participants in a control group may get no treatment, a treatment that’s already used to treat their health condition or disease, or a placebo (a harmless treatment that doesn’t have any impact on the disease) 

Having treatment and control groups help researchers understand how well the new medicine or other treatment works to treat the disease compared with giving no treatment — or a treatment that’s already used. 

Participants don’t have a say over which group they’re assigned to (nor do the doctors) — and in many cases, they don’t know which group they’re in. When participants don’t know which group they’re in, it’s called a blinded trial. When both the participants and the researchers don’t know who’s in which group, it’s called a double-blinded trial. Double-blinded clinical trials can help ensure that the trial data are accurate, because they can’t be influenced by how the participants or researchers feel about the trial or what they expect to happen. 

What Are The Possible Benefits And Risks Of Participating In A Clinical Trial? 

Deciding to participate in a clinical trial is a personal and important decision. To make an informed decision that’s right for you, it’s important to weigh the possible benefits and risks of participating.  

Benefits 

If you participate in a clinical trial, you have a chance to be one of the first people to try a new medicine or treatment for Sjögren’s disease. If the medicine works, it may make Sjögren’s easier to manage, improve your symptoms, or help you feel better. 

Participating in clinical trials also mean that you’re helping future Sjögren’s patients by helping to drive science forward. Even when a medicine doesn’t work as hoped or doesn’t get approved, clinical trials give researchers valuable information to help them develop better treatments in the future. 

Risks

There are risks to participating in clinical trials, too. Because part of the goal of clinical trials is to test the safety of a medicine or treatment, there’s a chance the medicine might harm you. Or, you might experience negative side effects from the medicine. There’s also no guarantee that the medicine or other treatment will work to treat your Sjögren’s disease. 

During the clinical trial, researchers will carefully monitor you for signs of possible harm or negative side effects. Plus, clinical trials are also monitored by a separate group of experts who aren’t involved in developing the medicine or treatment being tested. These experts have the power to stop the study at any time if they believe the trial is unsafe for participants. 

Participating in a Clinical Trial 

If you’re interested in participating in a clinical trial focusing on treatments for Sjögren’s disease, there are a few ways to find a trial: 

• Talk with your Sjögren’s doctor. They may be aware of upcoming clinical trials that are a good fit for you.
• Review the Sjögren’s Foundation’s list of active clinical trials. The trials listed on our Clinical Trials page are enrolling participants.
• Search for clinical trials on ClinicalTrials.gov. ClinicalTrials.gov is an online database of clinical trials taking place around the world. Keep in mind that the government does not review or approve the clinical trials listed on the site — it’s simply a tool to help provide information about clinical trials. 

Your Rights as a Patient in a Clinical Trial 

As a clinical trial participant, you must sign an informed consent document in order to participate. The informed consent document explains what the clinical trial is, what you’ll need to do, and what the possible risks of participating are. You have the right to take as much time as you need to read and sign the informed consent document. You also have a right to ask questions before signing. Once you sign the document, you have a right to keep a copy of it for your own records.