Unique ID issued by UMIN | UMIN000004242 |
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Receipt number | R000005096 |
Scientific Title | Leukocytapheresis for Maintenance of Remission in Patients with Refractory Inflammatory Bowel Disease: A single-centre, Randomized, Double Blinded Trial |
Date of disclosure of the study information | 2010/09/21 |
Last modified on | 2014/03/26 18:15:23 |
Leukocytapheresis for Maintenance of Remission in Patients with Refractory Inflammatory Bowel Disease: A single-centre, Randomized, Double Blinded Trial
Leukocytapheresis as Maintenance of Remission in Patients with Inflammatory Bowel Disease
Leukocytapheresis for Maintenance of Remission in Patients with Refractory Inflammatory Bowel Disease: A single-centre, Randomized, Double Blinded Trial
Leukocytapheresis as Maintenance of Remission in Patients with Inflammatory Bowel Disease
Japan |
Ulcerative Colitis
Medicine in general | Gastroenterology |
Others
NO
This is a prospective double-blinded randomized trial with sham column to assess the clinical and/or steroid tapering efficacy of monthly extracorporeal granulocyte/monocyte adsorption (GMA) as maintenance therapy in patients with quiescent UC, who could be induced to clinical remission by applying weekly GMA for 10 consecutive weeks in spite of having steroid refractory background.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II,III
The primary endpoint of the study is a non-relapsing ratio at 48 weeks, relapse is defined if a patient have to start PSL or increase the ongoing dosage, Clinical Activity Index (CAI) ≥ 5.
To evaluate mucosal UC activity, colonoscopy is done in all patients before and after remission induction therapy. Also, patients who achieve sustained remission at week 48 have colonoscopy at the end of study.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
YES
Institution is considered as a block.
YES
Central registration
3
Treatment
Medicine |
The patients assigned to the True arm, each receives one Adacolumn GMA session every 4 weeks for up to 48 weeks.
The circuit line was covered securely by a curtain to blind both the physician and the patients on the type of treatment.
The patients assigned to the sham arm, each receives one extracorporeal procedure with the circuit blood lines without the Adacolumn every 4 weeks for up to 48 weeks.
The circuit line was covered securely by a curtain to blind both the physician and the patients on the type of treatment.
The patients assigned to the control arm, each receives conventional medications without any extracorporeal circulation.
12 | years-old | <= |
75 | years-old | >= |
Male and Female
Gender and Age; Men and women age 12-75years and body-weight more than 39kg
Disease activity; Quiescent UC (less than 4 points in the clinical activity index established Lichtiger ,et al.) who have finished their remission induction therapy consisted 10 weekly GMA sessions for 10 consecutive weeks within 4 weeks prior to start study.
Exclusion criteria included therapy with cyclosporine, tacrolimus earlier than 4 weeks prior to start study, infliximab earlier than 8 weeks prior to start study. Also, patients with having granulocytopenia (neutrophil count <2,000/micro-liter), serious heart or kidney disease, coagulation disorder, history of hypersensitivity to heparin or heparin-induced thrombocytopenia, hypotension (<90/65mmHg) or uncontrolled hypertension (>180/ 120mmHg, despite medical therapy; anemia lower than 9.0g/dl in hemoglobin, and women being or wishing pregnant, were excluded.
30
1st name | |
Middle name | |
Last name | Takayuki Matsumoto |
Hyogo College of Medicine
Department of Lower Gastroenterology
1-1 Mukogawa, Nishinomiya, Hyogo Pref.
81798456662
1st name | |
Middle name | |
Last name | Ken Fukunaga |
Hyogo College of Medicine
Department of Lower Gastroenterology
kebe@hyo-med.ac.jp
Department of Lower Gastroenterology, Hyogo College of Medicine
None
Self funding
None
None
NO
兵庫医科大学病院
2010 | Year | 09 | Month | 21 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/23170145
Completed
2004 | Year | 03 | Month | 01 | Day |
2004 | Year | 04 | Month | 01 | Day |
2009 | Year | 12 | Month | 01 | Day |
2010 | Year | 08 | Month | 01 | Day |
2010 | Year | 08 | Month | 01 | Day |
2010 | Year | 08 | Month | 01 | Day |
2010 | Year | 09 | Month | 21 | Day |
2014 | Year | 03 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005096
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