Pulmonary Arterial Hypertension Clinical Trial
Official title:
A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension
An open label study to assess the safety and efficacy of tocilizumab in group 1 pulmonary arterial hypertension patients
In Pulmonary Arterial Hypertension (PAH) raised blood pressure in the lungs leads to heart
failure and early death. Patients not only have a significantly reduced life expectancy, but
their quality of life is severely affected. If left untreated life expectancy is 2-3 years.
Current treatments all aim to relax the vessels in the lung and lower the blood pressures,
however none target the causes of the disease and currently there is not cure. Despite the
availability of treatments the impact on mortality has been modest at best with one third of
patients still dying within two years of diagnosis. There remains an urgent need to test new
ways of treating PAH.
PAH is often associated with auto-immune diseases (when the bodies own system attacks itself
rather than fight infection). Targeting components of the immune system involved in the
development of disease offer a potential new area of treatment for PAH; an example known to
be involved in the progression of PAH is the protein Interleukin-6 (IL-6). Tocilizumab is a
drug which blocks the action of Interleukin-6 and blocking Interleukin-6 has been shown to be
effective in animal models of PAH. Tocilizumab was demonstrated to be safe and effective in
trials in other diseases associated with PAH, such as rheumatoid arthritis.
This study is a 6 month open label phase II trial of IV Tocilizumab in 21 patients with group
1 PAH. The aim of the trial is to see if Tocilizumab is safe and whether it reduces the blood
pressure in the lungs. Patients will be given Tocilizumab intravenously once a month for six
months with close safety monitoring. The trial will be led by Papworth Hospital and a total
of 7 UK specialist centres will take part. The trial will assess the safety of the drug and
response to treatment by measuring heart function, blood pressure in the lungs, exercise
capacity and quality of life measurements.
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