The purpose of this study is to evaluate the efficacy of the addition of GMA apheresis to steroid conventional treatment for achieving and maintaining remission in Active steroid dependant Ulcerative Colitis patients
This is a multicenter randomized controlled trial which will compare the efficacy and safety of Adacolumn GMA apheresis plus oral steroids vs steroids alone in a strictly selected population of moderate to severe active steroid dependant Ulcerative Colitis patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
133
GMA Apheresis will be performed in a once per week during seven weeks only in experimental arm. Each apheresis will last 60 minutes at a blood flow rate of 30 ml/min.
Proportion of patients in steroid free clinical remission defined by Mayo Score less or equal to 2 with no individual subscore >1 at week 24
Time frame: week 24
Steroid free remission (assessed by Mayo score)
Time frame: Week 12
Response at week 12 and 24 (defined by a decrease in Mayo Score > or = to 3 points
Time frame: week 12 and week 24
Acute Phase reactants change at all lab analysis
Time frame: 24 weeks
Rescue therapy requirements (new courses of steroids, cyclosporine, infliximab, or surgery) during study period
Time frame: 24 weeks
Time to relapse
Time frame: 24 weeks
· Clinical response according to the activity indexes Truelove & Witts, Powell Tuc, Rachmiliewitz (Clinical Activity Index), Lichtiger (Modified Truelove & Witts Severity Index), Walmsley (Simple Clinical Colitis Index
Time frame: 24 weeks
Clinical remission and response at weeks 12 and 24 analysed according to concomitant use of immunosupressants
Time frame: 24 weeks
Adverse events
Time frame: 24 weeks
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Medical University of Vienna
Vienna, Austria
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Essen, Germany
Markus-Krankenhaus
Frankfurt, Germany
Policlinico di Bari
Bari, Italy
Ospedale di Belluno
Belluno, Italy
Azienda Ospedaliero-Universitaria di Careggi
Florence, Italy
L'Azienda Unità Sanitaria Locale di Forlì
Forlì, Italy
Istituto Policlinico S. Donato
Milan, Italy
Policlinico di Padova
Padua, Italy
Policlinico Universitario Tor Vergata
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