About

The BEAT Lupus Trial

Testing the effectiveness and safety of a combination of two drugs to reduce Systemic Lupus Erythematosus (Lupus) disease activity

ELIGIBILITY CRITERIAPARTICIPATING HOSPITALS


Systemic Lupus Erythematosus


Systemic Lupus Erythematosus (SLE) is an autoimmune disease that occurs when a person’s antibodies, produced by immune B cells, mistakenly attack the body’s own cells.

This attack causes severe inflammation, with a range of problems including fatigue, rashes, hair loss, arthritis, kidney involvement and blood disorders. Long-term complications in SLE can include early onset heart attacks, strokes and kidney failure.

Protocol Synopsis

If you would like to know more about the study you can download the Protocol Synopsis which includes a description of the trial along with the inclusion and exclusion criteria.


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Patient Information Sheet

The Patient Information Sheet contains answers to many questions you may have about the trial. If you intend to talk to your doctor about participating, take a copy of this document.


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Questions

Answers to some common questions

  • What is the purpose of the study?
  • Do I have to be invited to join?
  • Do I have to take part?
  • What will happen to me if I take part?
  • Will it cost me anything to take part?
What is the purpose of the study?

This study aims to find out whether a drug called Belimumab (Benlysta) when used after B cell depletion therapy is both safe and effective in reducing systemic lupus erythematosus (lupus) disease activity.

B cell depletion therapy (normally rituximab) is being given as part of your normal treatment because your lupus is active. B cell depletion therapy removes a type of immune cell called B cells from the body. B cells can cause disease in lupus patients. Although patients respond to B cell depletion therapy the disease can quickly return. This is likely to be because a chemical (also known as a stimulating factor) called BAFF increases in the body once treatment ends, and switches the lupus back on.

Belimumab is a drug that stops BAFF from working and has been shown to work in patients with lupus. We will treat you with belimumab soon after B cell depletion therapy and we hope this combined treatment approach will prevent the lupus from coming back after rituximab therapy. However, we don’t know yet whether giving belimumab is any better than simply having B cell depletion therapy alone.

Do I have to be invited to join?

If you have lupus and your disease has not responded to treatment with medication such as steroids and mycophenolate then you may be eligible for this study. Patients whose disease does not normally respond to these treatments can receive rituximab as part of their normal care. We aim to recruit 50 lupus patients to this study who have received B cell depletion therapy in the last month or so.

Do I have to take part?

We may think you are suitable to participate in the study but it is up to you to decide if you want to or not. We will describe the study and go through the patient information sheet with you. If you agree to take part we will then ask you to sign a consent form. You are free to withdraw your consent at any time without giving a reason. This will not affect the standard of care you receive.

What will happen to me if I take part?

You will be asked a series of questions to see if you might be eligible to join the study. If you are eligible at this point you will be asked to attend a Hospital to be asked more details about your condition and be examined and have blood and urine tests. If this assessment confirms you are eligible, you will be entered into the study and will be invited to attend the Hospital again.

You will return to hospital to have further blood tests and an ECG (a test of your heart). If you are a woman and of child bearing age then you will have a pregnancy test at each visit and as noted below you will be asked to use appropriate contraception so that you will not get pregnant whilst you are in the study. Tests will be run for serious infections such as HIV or Hepatitis. All these tests are tests you would have as part of your normal care.

This is a randomised study. We don‘t know the best way of treating patients after B cell depletion therapy. To find out, we need to compare a new treatment (belimumab) with usual treatment. We will put people into groups and give one group belimumab and the other group the usual treatment. The results are compared to see if one is better. To try to make sure the groups are the same to start with, each patient is put into a group by chance (randomly). The decision as to which group you will be put in will be made by a computer. Half the patients receive belimumab and half receive placebo. Both treatments will be given by intravenous infusion. The placebo treatment will look the same as belimumab but contains no active drug. The reason for including a placebo is so neither you nor your doctor knows whether belimumab has been given. Sometimes simply knowing what treatment has been given can affect the way a patient is feeling. We will be able to compare the information from patients in the belimumab group, with the information from the placebo group and be able to determine what effect belimumab is having on Lupus.

Your doctor will be able to find out which group you are in should there be a need to, but this does not usually happen while you are taking part in the study. All patients will be invited to attend for an infusion of the study medication which will last an hour (but you may be monitored for a few hours after the first couple of infusions) and you will repeat treatments and assessments, usually every four weeks. The results of the study will be available for general use by researchers in the field of Lupus, to ensure that the information gathered from the study is put to maximum use. Your personal details will not be revealed at any stage.

Will it cost me anything to take part?

We will pay your travel expenses if you take part in the study.

Our Goals


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HOSPITALS

The trial will be run in 16 hospitals across the UK.


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PARTICIPANTS

We aim to recruit 50 participants in to the trial.


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RECRUITED

We are 60% of the way to our recruitment goal.


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WEEKS

The treatment period for each participant.


Contact us

Contact the Clinical Trial Manager or Data Manager for more information about the BEAT Lupus trial.


CLINICAL TRIAL MANAGER

Felicia Ikeji
020 7679 9506
f.ikeji@ucl.ac.uk
CTU.beatlupus@ucl.ac.uk



DATA MANAGER

Miriam Pollard
0207 907 4691
m.pollard@ucl.ac.uk
CTU.beatlupus@ucl.ac.uk



Trial Identifiers

EudraCT : 2015-005543-14
ISRCTN : ISRCTN47873003


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