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ADAPT – Adacolumn® paediatric trial PDF Print E-mail

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

  • Age below 18 and a body weight above 30 kg

  • Ulcerative colitis (left-sided or pancolitis), moderately active with a PUCAI between 35 and 64

  • 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 ( This e-mail address is being protected from spam bots, you need JavaScript enabled to view it )

 

 
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