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An International, Open Label, Randomised Controlled Trial Comparing Rituximab with Azathioprine as Maintenance Therapy in Relapsing ANCA-Associated Vasculitis

Vasculitis is inflammation of blood vessels in your body. The exact cause is unknown, but we do know that it is an autoimmune condition. This means that your body’s own immune system, that normally fights infection, is overactive and is damaging your own blood vessels. Vasculitis can affect almost any part of the human body. Vasculitis can be very serious if left untreated. This study will investigate whether repeating rituximab really works well in stopping vasculitis returning and is better than the drugs usually used for this purpose-azathioprine or methotrexate. It will also tell us how long patients remain well after the repeated rituximab treatments are stopped, and whether repeated rituximab is safe. The trial results will help decide the best treatment for future patients who have their vasculitis initially treated with rituximab.

Detailed Description

Rituximab is an FDA-approved drug used for the treatment of AAV, especially for those patients whose disease returns (‘relapsing disease’). After a time, its effect wears off and the disease can return again. This occurs in at least half of patients within two years of receiving rituximab. A preliminary study has suggested that repeating rituximab every six months is safe and stops the disease returning. Standard treatment of vasculitis is a combination of drugs including glucocorticoids (steroids such as prednisone) and a second drug to suppress the body’s immune system. During the study, we will also learn more about blood tests that may predict response to treatment of vasculitis and the likelihood of relapse. In order to do this, extra blood tests will be taken at the same time as your routine tests.

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Age icon
Age
15 - 99
Gender icon
Gender
All
NCT ID icon
NCT ID
816166
Phase icon
Phase
3
Status icon
Status
Recruiting Now
Medical Condition icon
Medical Condition
Microscopic Polyangiitis

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Medical Condition
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The Study
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About Clinical Trials
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Your Journey

01
Receiving the medication
You would receive etanercept (Enbrel) twice a week for 12 weeks and then once a week for 12 weeks. Etanercept, as well as study related medical care, is provided at no cost.
02
Visiting the study site
Study participation involves approximately 8 visits to your local study center over 6 to 7 months.
03
Follow-up
There would also be a follow-up telephone call 30days after completing the study. No visits are required after participation is complete.

Call 1800-9860-568 now to find out if you are eligible.