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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 2 April 2019
Main ID:  JPRN-UMIN000005689
Date of registration: 31/05/2011
Prospective Registration: Yes
Primary sponsor: Department of Gastroenterology and Hepatology, Kyoto University Hospital
Public 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
Scientific title:
Date of first enrolment: 2011/09/01
Target sample size: 60
Recruitment status: Complete: follow-up complete
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006728
Study type:  Interventional
Study design:  Parallel Randomized  
Phase:  Not applicable
Countries of recruitment
Japan
Contacts
Name: Minoru Matsuura   
Address:  54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan Japan
Telephone: 075-751-4319
Email: minomats@kuhp.kyoto-u.ac.jp
Affiliation:  Kyoto University Hospital Department of Gastroenterology and Hepatology
Name: Hiroshi Nakase   
Address:  54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan Japan
Telephone: 075-751-4319
Email: hiropy_n@kuhp.kyoto-u.ac.jp
Affiliation:  Kyoto University Hospital Division of Endoscopic Medicine
Key inclusion & exclusion criteria
Inclusion criteria: 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

Exclusion criteria: 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


Age minimum: 12years-old
Age maximum: 75years-old
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)
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.
Primary Outcome(s)
Remission (CDAI<150) rate at the end of the study (intensive GMA plus azathioprine: at week 7, Infliximab plus azathioprine: at week 8)
Secondary Outcome(s)
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
Secondary ID(s)
Source(s) of Monetary Support
JIMRO Co.,Ltd.
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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