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ADAPT – Adacolumn® paediatric trial |
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What is Adacolumn®?
Adacolumn® is an apheresis system, i.e. a system to clear blood from
substances, molecules or cells. It removes activated leukocytes from
the blood without significant loss of other cells or fluids. Cells
removed can no longer maintain inflammation processes present in
ulcerative colitis.
Adacolumn® is approved (CE certified) and since about 10 years in use
for the treatment of inflammatory bowel diseases (ulcerative colitis
and Crohn’s disease). In adults Adacolumn® has already been shown to be
safe and efficacious.
The ADAPT trial
The ADAPT trial investigates if these efficacy and safety results
can also be confirmed in a paediatric patient collective. The trial is
currently ongoing in Denmark, Germany, Italy, Finland, Sweden, and the
UK. Main inclusion criteria are
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Age below 18 and a body weight above 30 kg
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Ulcerative colitis (left-sided or pancolitis), moderately active with a PUCAI between 35 and 64
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Pre-treatment with 5-asa or derivatives, mercaptopurines and or
steroids; if treatment is ongoing, doses must have been stable for
defined times
Pre-treatment with immuno-modulators and/or biologics is an exclusion criterion.
The trial has a basic duration of 3 months for a patient, and a follow-up extension over 1 year for responders.
For more information, please contact Dr. Marita Franz at Otsuka’s Research Institute in Frankfurt, Germany (
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