Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus
This research is testing a new tablet, upadacitinib, for adults in the UK living with moderate to severe Systemic Lupus Erythematosus (SLE), often called lupus. Lupus is a condition where your immune system attacks your body, causing inflammation in different organs. The main goals of this study are to see how safe the new drug is and if it helps to lessen the effects of lupus. Some participants will receive the actual drug, while others will be given a placebo (a tablet with no active medicine). Neither the patient nor their doctor will know which they are getting at the start. The study involves regular clinic visits, medical checks, and questionnaires to track progress and any side effects over time.
At a glance
What is this study about?
This study is all about finding better ways to help people living with Systemic Lupus Erythematosus (SLE), also known as lupus. Lupus is a long-term condition where your body's immune system, which normally fights off infections, mistakenly attacks your own healthy tissues. This can cause inflammation and damage in many parts of the body, like joints, skin, kidneys, and other organs.
The researchers want to see if a medicine called upadacitinib, which is already used for other conditions like rheumatoid arthritis, can safely and effectively treat lupus. They are particularly interested in adults who have moderate to severe forms of the condition. By carefully monitoring participants, they hope to understand if this new treatment can reduce lupus symptoms and improve people's health.
To make sure the results are as clear and fair as possible, this study is 'double-blind'. This means that neither you, if you choose to take part, nor your study doctor will know whether you are receiving the upadacitinib tablet or a placebo (a dummy pill with no active medicine). This helps prevent anyone's expectations from influencing how the treatment's effects are observed.
Key takeaways
- This study is testing a new tablet for moderate to severe lupus.
- It's a 'double-blind' study, meaning you won't know if you're getting the drug or a dummy pill initially.
- You'll have regular visits, medical checks, and fill out questionnaires.
- The main treatment period is about one year, with potential for longer participation.
- Participation involves more medical appointments than standard care.
- You can stop taking part at any time without affecting your usual care.
Who may be eligible?
For this study, researchers are looking for adults between 18 and 63 years old who have a confirmed diagnosis of Systemic Lupus Erythematosus (SLE), or lupus, which has been in place for at least 24 weeks. Your lupus needs to be moderately to severely active when they check you for the study. This is measured by specific medical tests and assessments.
You also need to be on a stable dose of your current lupus medications for a certain period before the study starts. This could include anti-malarial drugs, a specific dose of steroid tablets, or certain other immunosuppressant medicines. The study will check your medical history carefully to make sure these requirements are met.
There are also some reasons why you might not be able to join. For example, if you've had certain serious kidney problems (Class III/IV lupus nephritis) or active mental health issues related to lupus (neuropsychiatric SLE) within the last six months, you wouldn't be eligible. They will also exclude you if your lupus overlaps with certain other specific conditions.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 63 years old?
- Do you have a confirmed diagnosis of lupus (SLE) for at least 24 weeks?
- Is your lupus currently of moderate to severe activity?
- Are you on a stable dose of your current lupus medications for the required time?
- Have you been free from certain serious lupus-related kidney or brain issues in the last 6 months?
What does participation involve?
If you decide to take part, you'll be given either the study drug (upadacitinib) or a matching placebo tablet to take once daily. You won't know which one you're receiving at the beginning. This first part of the study lasts for 52 weeks (about a year).
During this time, you'll need to attend regular clinic or hospital visits. At these visits, the study team will carry out medical assessments, check for any side effects, and ask you to complete questionnaires about how you're feeling and your symptoms. This helps them understand how the treatment is working and if it's safe.
After the first 52 weeks, if you meet certain criteria, you might be able to continue on to further parts of the study, where you would receive specific doses of upadacitinib. One part could last another 52 weeks, and there's also an option for a longer extension of up to 104 weeks (two years) if continuing to take part is likely to benefit your lupus. Overall, taking part in a clinical trial like this usually means more hospital trips and tests than your usual care.
Potential risks and benefits
Locations (369)
- AZ Arthritis and Rheumatology /ID# 261848Verified postcodeChandler, United States
- AZ Arthritis and Rheumotology Research, PLLC - Flagstaff /ID# 254767Verified postcodeFlagstaff, United States
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 252820Verified postcodeGilbert, United States
- Arizona Arthritis and Rheumatology Research - Glendale Office /ID# 252824Verified postcodeGlendale, United States
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 261845Verified postcodeMesa, United States
- Arizona Arthritis & Rheumatology Research /ID# 273555Verified postcodePeoria, United States
- Arizona Arthritis & Rheumatology Associates - East Bell Road /ID# 252831Verified postcodePhoenix, United States
- Arizona Arthritis & Rheumatology Research, PLLC /ID# 252825Verified postcodePhoenix, United States
- HonorHealth Rheumatology /ID# 261953Verified postcodeScottsdale, United States
- Arizona Arthritis & Rheumatology Associates - Tucson /ID# 252828Verified postcodeTucson, United States
- Arthritis and Rheumatism Associates /ID# 253033Verified postcodeJonesboro, United States
- Kaiser Permanente Lakeview Medical Offices /ID# 253906Verified postcodeAnaheim, United States
Common questions
What is upadacitinib?
Upadacitinib is a tablet medicine that is being tested to see if it can help reduce inflammation and symptoms in people with lupus. It is already approved for other conditions like rheumatoid arthritis.
What is a 'placebo'?
A placebo is a 'dummy' tablet that looks just like the study drug but doesn't contain any active medicine. It helps researchers compare the effects of the actual drug against no treatment.
What does 'double-blind' mean?
It means that neither you nor your study doctor will know whether you are receiving the upadacitinib tablet or the placebo. This helps ensure the results are fair and unbiased.
How long will I need to be in the study?
The main part of the study lasts for 52 weeks. If you meet certain conditions, you might be able to continue for longer periods, potentially up to an additional two years.
Can I stop participating in the study if I want to?
Yes, you have the right to leave the study at any time, for any reason. This will not affect the medical care you receive for your lupus.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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