Rheumatoid Arthritis Clinical Trial
Official title:
The Use of Anti-CD4 mAb-Fragment for the Imaging of Chronic Inflammation in Patients With Active Rheumatoid Arthritis (an Open Proof of Concept Study)
Rheumatoid arthritis (RA) is a disease with a large economic impact due to the long lasting
disabling nature of the disease. Furthermore, diagnosis of the disease is difficult and only
a scheme with different symptoms is used to diagnose rheumatoid arthritis, often only by
probability.
Due to the fact that effective disease modifying pharmacological treatment is available and
should be started early in established cases of RA, in combination with the adverse effect
potential of these substances (e.g. methotrexate), a fast reliable diagnostic tool to
diagnose rheumatoid arthritis would be highly appreciated by the medical community and the
patients. Furthermore, for invasive treatments (surgery, puncture), an imaging method to
display the activity pattern in different joints would be a major advantage.
For the evaluation of the effectiveness of pharmacological therapy in rheumatoid arthritis,
up to now, radiological measurements of the destruction process of the joints are used. This
method has the disadvantage that it is time consuming insofar as changes in the radiological
images must occur. It allows only an evaluation if the joints are destructed (which should
be excluded by the new therapy regimen). Again, a quantifiable method for the determination
of the effects of new therapeutic approaches would be highly appreciated.
The substance will be used as iv injection due to the protein nature of the antibody and, to
ensure a fast distribution within the body. The study will be performed as an open clinical
trial due to the fact that the applied radiation has to be documented; the use of "placebo"
radiation would be unethical.
It is expected, that the new antibody fragment with its radioactive linkage will display an
image of the activity distribution of the disease. Due to the fact that only patients with
active disease have to be imaged and, to allow for comparison of the activity and the
clinical distribution of the disease, this proof of concept study (phase I study) will be
performed in patients with active disease. Healthy volunteers could not display an activity
pattern of the disease. Furthermore, it seems to be unethical to use volunteers for studies
with radioactivity with such a risk/benefit ratio (radiation risks vs. missing chance of
display of tissue distribution) in a proof of concept study.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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