How Clinical Trials Work
Thank you for your interest in learning more about lupus clinical trials! A number of the largest pharmacology organizations, academic institutions and private research facilities across the country are diligently working on developing treatments for lupus in a variety of clinical trials. Here’s a look at what a lupus clinical trial might involve:
Primary Investigator
A primary investigator, or PI, is the physician in charge of the clinical trial, who is responsible for coordinating, managing and overseeing the clinical study. That individual carries out what is called a…
Protocol
This refers to a document that describes how the trial is designed, and outlines how it should be carried out.
Interventional vs. Non-Interventional
Clinical trials can be classified in different ways, depending on their methods. Interventional studies mean that they test out an intervention, like a drug, procedure or medical device. Non-interventional studies, also called observational studies, don’t test potential treatments. Instead, researchers observe the participants over a period of time, and track health outcomes.
Who Can Participate?
Here are the qualifications interested potential participants need to meet in order to join a clinical research study for lupus:
- Be at least 18 years of age or older
- Have a confirmed diagnosis of any form of lupus
- Are willing and able to attend all appointments (including in-person) at a clinical site for the duration of that study
Learn more about if you may be eligible for participation in a lupus clinical trial.
Understanding Lupus
Lupus is a disease in which your body’s immune system attacks its own tissues and organs, hence it being classified as an autoimmune disease. The inflammation lupus causes can affect many different body systems—including your brain, lungs, heart, blood cells, joints, kidneys, and skin. The most telltale sign of lupus occurs in many, but not all, cases, and involves a facial rash that resembles the wings of a butterfly unfolding across both cheeks. Some people are even more likely to develop lupus, which can be triggered by infections, certain prescription drugs, and even sunlight.2.
These are the 4 different forms of lupus:3.
Systemic lupus erythematosus
When people talk about lupus, this is generally the form they’re referring to, as it accounts for approximately 70 percent of all lupus cases. In roughly 50% of these cases, a major organ or tissue in the body, such as the heart, brain, lungs, or kidneys, will be affected.
Cutaneous lupus
The cutaneous type of lupus is so named because it affects only the skin. It is further broken down into acute, chronic, and subacute forms, and a skin biopsy is sometimes necessary to diagnose these forms of lupus, as each has its own characteristic lesions and patterns. Cutaneous cases account for approximately 10% of all lupus cases.
Drug-induced lupus
Drug-induced lupus is caused by, as the name suggests, high doses of certain prescription medications, and it accounts for around 10% of all lupus cases. Symptom-wise, the way that drug-induced lupus presents in patients is similar to that of systemic lupus, including in the joints and inflammation around the lungs. Luckily, symptoms usually subside when those medications are discontinued.
Neonatal lupus
Neonatal lupus is the rarest form of lupus, in which the mother’s antibodies affect the fetus. Though the baby may have a skin rash, liver problems, or low blood cell counts at birth, these symptoms typically disappear after six months with no lasting effects.
How Is It Treated?
Depending on which form of lupus a patient has, and because lupus can cause many different symptoms, there are several different types of medicines that can help treat it. The most common medicines used to treat lupus include anti-inflammatories to help with inflammation and pain, antimalarial medications to protect the skin from rashes and UV light, biologics to help the immune system function properly, anticoagulants to help prevent blood clots, steroids to help with inflammation, and immunosuppressives to keep your immune system from attacking your body. There is no cure for lupus currently, however having the right treatment plan can help patients control their symptoms, protect your organs from damage, and keep your immune system from attacking itself. But the fact remains that treating lupus is difficult, and can take years to find the right combination of options. For this reason, many people have turned to clinical trials to shed more light on their condition, and how best to navigate it. 4.
Hope for the Future
Every day, numerous research and pharmacological companies are studying new cures and treatments for lupus all across the country (and world!). Lupus trials play a key role in determining the efficacy of those treatments, and helping to get them to market.
More than 1,500,000 Americans are estimated to suffer from Lupus, with the number reaching 5 million individuals with a lupus diagnosis worldwide.2
Frequently Asked Questions
What are the symptoms of lupus?
Most people with lupus experience episodes—called flares—when signs and symptoms get worse for a while, then improve or even temporarily disappear, however overall their disease severity is considered mild. The signs and symptoms a person with lupus experiences will depend on which body systems are affected by the disease, and may be mild or severe, temporary or permanent, come on quickly or develop slowly, and look different in every person.
The most common signs may include:5
- Joint pain, stiffness and swelling
- Fatigue
- Fever
- A butterfly-shaped rash on the face that covers the cheeks and bridge of the nose, or rashes that appear elsewhere on the body
- Headaches, confusion and memory loss
- Skin lesions that show up, or worsen, with sun exposure
- Fingers and toes that turn white or blue when exposed to cold or as a result of stress
- Shortness of breath
- Chest pain
- Dry eyes
5. Source: https://www.mayoclinic.org/diseases-conditions/lupus/symptoms-causes/syc-20365789
Who may be a good candidate to apply for a lupus clinical trial?
You should consider applying for a lupus research study if you:
- Are at least 18 years of age or older
- Have had a confirmed diagnosis of lupus
- Are willing and able to attend all appointments (including in-person) at a clinical site for the duration of that study
What will happen during a lupus clinical trial?
Most clinical trials will involve frontline screening to confirm that a potential patient is, in fact, a match for that study’s criteria. Once verified and the patient has signed an informed consent form, which clearly provides the details and purpose of the study to that individual and what it involves, participants can expect to attend scheduled appointments at a clinician’s office. They will also receive a prescribed medication (called an investigational treatment), and undergo additional screening and regular follow-up monitoring from a clinician and/or research staff. Throughout the study, participants should expect to enjoy a safe, caring clinical environment, and be treated with compassion and respect.
Are there any costs to participate in a clinical research study?
In almost all instances, there is no cost to participate in a clinical trial. Participants receive all study-related medical care and medications for the duration of the study. Likewise in many instances, patients also enjoy benefits such as compensation for time and travel.
Still have questions?
Contact us anytime at help@clinicalenrollment.com