Robin Rheumatic Disease Study

About the condition

In an autoimmune disease, the body’s immune response is incorrectly being activated by normal components of your cells, causing it to attack and damage your body’s own tissues.  Recent data suggests a type of white blood cell called a B cell plays a central role in causing or worsening the disease

Lupus is what's known as an autoimmune condition. In these types of conditions, the body's immune system produces antibodies that attack a person's own healthy tissue as if it were a foreign body, like bacteria or a virus. Lupus is a complex condition that affects different people in different ways. It may affect joints and skin. It can also affect blood vessels and internal organs. Around one in every 900 people in Aotearoa, New Zealand, is diagnosed with lupus. It's more common in Māori and Pasifika peoples and in other ethnic groups with darker skin. It can occur in men, women and children, but it's much more common in women. (Healthify NZ) (Dermnet NZ)

About the investigational medication

B cells play a large role in the immune response that is overactive with autoimmune diseases. Reducing the number of B cells in your body may be able to lower the abnormal, overactive immune response to a normal level. The investigational medication is a type of antibody made in a laboratory. Antibodies are Y-shaped proteins that form part of your immune system. The medication serves as an addition to your own antibodies. They act by restoring or modifying your immune system activity to a normal level through their ability to trigger an attack against cells that are abnormally stimulated in autoimmune rheumatic diseases, which are B cells.

The investigational medication has already been given to healthy volunteers and it has shown favourable safety and effects on B-cells indicating it could be a potentially promising new drug for patients with rheumatic disease.

The investigational medication is administered through an intravenous infusion at the clinic.

Reason to participate

Your involvement in this study may help advance scientific knowledge that could contribute to the development of a new medication and better treatment for people with the same disease in the future.

About the study

Around 36 people globally are taking part in this study. Taking part in this study may last around 8-9 months. There is an initial visit to the clinic to talk with the doctor about the study and see if you might be eligible. If you wish to participate, there are around 17 clinic visits over around 6 months, with 4 visits lasting a minimum of 7 hours and 5 visits lasting a minimum of 3 hours. At these visits, the study medicine is administered through an intravenous infusion at the clinic into a vein in your arm. The remainder of visits are around 30-45 minutes. At clinic visits, there are physical examinations, health reviews, blood samples, and ECGs. Taking part may involve up to 2 to 3 tissue samples, called biopsies.

Duration of study
If eligible, you will have 26 weeks of treatment and at least 8 weeks of follow-up. The total duration of your study participation will last up to approximately 8-9 months.

• There are around 17 visits over a treatment period of 6 months and at least 2 visits following completion of treatment.
• There are 4 visits lasting a minimum of 7 hours.
• There are 5 visits lasting a minimum of 3 hours.
• The remainder of visits are around 30-45 minutes.

Procedures undertaken

Tissue samples, biopsies, ECGs, blood tests, physical exams, vital signs and health checks.