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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-UMIN000006889
Date of registration: 01/01/2012
Prospective Registration: Yes
Primary sponsor: Department of Lower Gastroenterology, Hyogo College of Medicine
Public title: Evaluation of Concomitant Infliximab and Granulocyte/ Monocyte Adsorption Apheresis in Crohn's disease Patients who lose Response to 5mg/kg/dose Infliximab Therapy
Scientific title:
Date of first enrolment: 2012/01/01
Target sample size: 50
Recruitment status: Complete: follow-up complete
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008136
Study type:  Interventional
Study design:  Parallel Randomized  
Phase:  Phase IV
Countries of recruitment
Japan
Contacts
Name: Ken Fukunaga   
Address:  1-1 Mukogawa, Nishinomiya, Hyogo Pref. Japan
Telephone: 0798456662
Email: kebe@hyo-med.ac.jp
Affiliation:  Hyogo College of Medicine Department of Lower Gastroenterology
Name: Shiro Nakamura   
Address:  1-1 Mukogawa, Nishinomiya, Hyogo Pref. Japan
Telephone: 0798-45-6660
Email: shiro@hyo-med.ac.jp
Affiliation:  Hyogo College of Medicine Department of Lower Gastroenterology
Key inclusion & exclusion criteria
Inclusion criteria: (1) Patient of ileo-colitis or colitis type Crohn's disease
(2) Patients with Crohn's disease showing temporary clinical remission (CDAI less than 150) in response to 5mg/kg/dose infliximab therapy but poorly responding (CDAI over 175 and increase more than 50 points during the recent 4 weeks) to subsequent maintenance infliximab therapy (5mg/kg/dose, every 8 weeks).
(3) Patients age from 16 to 74.
(4) Patients considered being capable for venous catheter insertion

Exclusion criteria: (1) Cases that granulocyte count below 2000/mm3
(2) Cases that complication by infection present or suspected
(3) Patients with severe heart disease
(4) Patients with severe kidney disease
(5) Patients with hypotension (Systolic blood pressure less than 80mmHg)
(6) Patients willing or being pregnant (or lactation).
(7) Patient with severe dehydration and/or hyper-viscosity. Patients with severe anemia (Hb <8g/dL)
(8) Patients with malignant tumor
(9) Patients with colostomy
(10) Patients with uncontrollable external-fistulas.
(11) Patients with intestinal stenosis.
(12) Patients with severe extra-intestinal complications.
(13) Patients with short bowel syndrome.
(14) Patients after total colectomy.
(15) Patients who have been treated with corticosteroids (iv, po, or topical) within 2 weeks.
(16) Patients who have treated with intravenous hyperalimentation (IVH) within 4 weeks.
(17) Patients who have been given more than 1,200kcal of elemental nutrition within 4 weeks.
(18) Patients who have episode of starting or increasing dosage of thioprine within 8 weeks.
(19) Patients who do not submit informed consent
(20) Patients who have been treating with non-approval therapy and/or enrolling other clinical trials.
(21) Other patients judged as inappropriate by the physician


Age minimum: 16years-old
Age maximum: 75years-old
Gender: Male and Female
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)
Repeat 3 sets of the concomitant therapy with IFX and GMA. Each set is consisted from a single 5mg/kg/dose of infliximab infusion plus 3 times of weekly GMA at 5, 6, and 7 weeks after IFX infusion.
Repeat 3 infusions of the 10mg/kg/dose infliximab in 8 weeks interval.
Primary Outcome(s)
Change in CDAI at 24 weeks relative to the base-line
Secondary Outcome(s)
(1) CDAI scores at each observation period
(2) The CDAI 50 points improvement ratio (CR50) at each observation period
(3) Remission (CDAI<150) induction rate at each observation period
(4) Change in CDAI at each observation period relative to the base-line.
(5) The CRP values at each observation period
(6) Change in CRP and ESR at each observation period relative to the base-line.
(7) Change in secretions of the various peripheral cytokine at each observation period relative to the base-line.
(8) Endoscopic and/or barium enema evaluation comparing between pre- (-8 to 0 week) and post- (24 to 28 weeks) allocation
(9) Incidence of adverse events
etc.
Secondary ID(s)
Source(s) of Monetary Support
Department of Lower Gastroenterology, Hyogo College of Medicine
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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