Unique ID issued by UMIN | UMIN000005689 |
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Receipt number | R000006728 |
Scientific Title | GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial |
Date of disclosure of the study information | 2011/05/31 |
Last modified on | 2016/02/11 10:36:51 |
GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial
Effect of GMA early combined with azathioprine on induction of remission in active Crohn's disease
GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial
Effect of GMA early combined with azathioprine on induction of remission in active Crohn's disease
Japan |
Crohn's disease
Gastroenterology |
Others
NO
To evaluate the efficacy and safety of GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine in comparison with Infliximab plus azathioprine, for induction of remission in active Crohn's disease, in a multicenter, prospective, randomized, controlled, non-blinded study
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
Remission (CDAI<150) rate at the end of the study (intensive GMA plus azathioprine: at week 7, Infliximab plus azathioprine: at week 8)
1) Clinical response (70 points reduction in their CDAI)
2) Reduction in CRP
3) Cytokine profile in CD4 positive T cell
4) Cumulative non-relapse rate
5) Safety assessment
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine | Device,equipment |
Patients in the combination therapy of GMA with azathioprine receive intensive GMA (twice per week, total 10 sessions) and oral azathioprine.
Patients in the combination therapy of Infliximab and azathioprine receive infusion of IFX (at week 0, 2, 6) and oral azathioprine.
12 | years-old | <= |
75 | years-old | > |
Male and Female
1) Patients with moderately to severely active Crohn's disease (CDAI 220-450)
2) Adequate peripheral venous access to allow for completion of GMA
3) Able to provide informed consent
1) Patients with granulocyte count of equal to or less than 2,000/mm3
2) Patients with serious infectious disease
3) Patients with serious heart disease
4) Patients with serious kidney disease
5) Patients with hypotension (less than maximum blood pressure 80mmHg)
6) Patients who are pregnant or have the possibility of pregnancy
7) Patients with serious dehydration, hypercoagulability, serious anemia (under haemoglobin 8g/dl)
8) Patients with malignancy
9) Patients with Short-bowel syndrome
10) Patients with permanent ostomy
11) Patients with external fistula, including poor control of anal fistula
12) Patients with total colectomy and subtotal colectomy
13) Patients with intestinal stenosis to cause intestinal obstruction
14) Patients with serious extraintestinal complication
15) Patients who had undergone previous immunosuppressive therapies
16) Patients who had undergone previous biologic therapies
17) Patients who had introduced or increased the dosage of Steroids (intravenous Infusion, oral, enema, suppository) within the last 2 weeks
18) Patients who had introduced or increased the dosage of Metronidazole within the last 2 weeks
19) Patients who had introduced or increased the dosage of Mesalazine sulfasalazine (oral, enema, suppository) within the last 4 weeks
20) Patients who had introduced or increased the dosage of elemental diet within the last 4 weeks
21) Patients who had undergone the operation (except replace of Seton) for anal fistula within 4 weeks
22) Patients who had undergone total parental nutrition with in last 4 weeks
23) Patients who had undergone the operation, including strictureplasty, for bowel within the last 12 weeks
60
1st name | |
Middle name | |
Last name | Hiroshi Nakase |
Kyoto University Hospital
Division of Endoscopic Medicine
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
075-751-4319
hiropy_n@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Minoru Matsuura |
Kyoto University Hospital
Department of Gastroenterology and Hepatology
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
075-751-4319
minomats@kuhp.kyoto-u.ac.jp
Department of Gastroenterology and Hepatology, Kyoto University Hospital
JIMRO Co.,Ltd.
Profit organization
JAPAN
NO
京都大学医学部附属病院(京都府)
大阪府済生会中津病院(大阪府)
大津日本赤十字病院(滋賀県)
北野病院(大阪府)
神戸市立医療センター中央市民病院(兵庫県)
神戸市立医療センター西市民病院(兵庫県)
西神戸医療センター(兵庫県)
2011 | Year | 05 | Month | 31 | Day |
Unpublished
Completed
2011 | Year | 03 | Month | 17 | Day |
2011 | Year | 09 | Month | 01 | Day |
2013 | Year | 05 | Month | 31 | Day |
2014 | Year | 05 | Month | 01 | Day |
2014 | Year | 05 | Month | 01 | Day |
2011 | Year | 05 | Month | 31 | Day |
2016 | Year | 02 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006728
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