Systemic Lupus Erythematosus Arthritis Clinical Trial
Official title:
A Feasibility Randomised Placebo-controlled Trial With Objective Outcome Measures to Evaluate the Efficacy of Biosimilar Rituximab in Musculoskeletal and Mucocutaneous Systemic Lupus Erythematosus
This is a feasibility study to test a new trial design for an important drug in Systemic
Lupus Erythematosus (SLE or "lupus").
SLE is an autoimmune disease. The immune system attacks the body's own tissues, any part of
the body may be affected, but most commonly lupus causes a rash and arthritis, this affects
patients' quality of life.
Lupus is usually treated with steroids or drugs that suppress the immune system. Although
these help, many patients don't respond well enough and there is also concern for long term
side effects. There is a new type of treatment called biologics. These target individual
cells or molecules rather than the whole immune system and may be more effective with fewer
side-effects. B cells are a part of the immune system that are known to play a role in lupus.
There is already a biologic that removes these, called rituximab. In rheumatoid arthritis and
vasculitis (similar to lupus), rituximab has been proven to be effective in clinical trials.
However, in lupus clinical trials it did not seem to show any benefit. But many doctors and
patients found that rituximab is effective, but the trials couldn't show this because of the
way the drug's effects were measured. Therefore it is important that we test whether it truly
is effective for lupus.
In this 6 month clinical study the investigators will look at lupus patients who have skin
disease and arthritis as these are very common and randomise them to receive either rituximab
or a placebo. Patients will have a careful clinical examination and undergo different methods
to measure the effectiveness of the treatment. There are new versions to rituximab called
"biosimilars". In this study biosimilar GP2013 will be used.
If this trial is successful a larger definitive study will be designed based on its results.
n/a
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