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Main
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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. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000015068 |
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Date of registration:
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05/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis
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Scientific title:
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Date of first enrolment:
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2014/09/05 |
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Target sample size:
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150 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015858 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Yoshitaka Ueno
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Address:
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1-2-3 kasumi minami-ku Hiroshima city
Japan |
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Telephone:
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082-257-5193 |
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Email:
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yueno@hiroshima-u.ac.jp |
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Affiliation:
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Hiroshima University Hospital Department of Endoscopy |
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Name:
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Shinji Tanaka
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Address:
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1-2-3 kasumi minami-ku Hiroshima city
Japan |
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Telephone:
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082-257-5538 |
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Email:
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colon@hiroshima-u.ac.jp |
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Affiliation:
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Hiroshima University Hospital Department of Endoscopy |
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Key inclusion & exclusion criteria
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Inclusion criteria: ?Patients with moderate to severe activity defined by a DAI score of more than or equal to 6
?Patients with steroid-dependent or steroid-resistant
?Patiens relapse frequently or Chronic persistent type
Exclusion criteria: ?Granulocyte count is equal to or less than 2000/ mm3
?Serious infectious disease
?Active tuberculosis
?Patients who have a Hypersensitivity against Infliximab or Protein from mice
?Demyelinating disease
?Congestive heart failure
?Serious heart disease
?Serious kidney disease
?Hypotonicity (less than maximum blood pressure 80mmHg)
?Pregnancy or suspected
?Serious exsiccation / serious coagulation, serious anemia(under hemoglobin 8g/dl)
?Malignancy
?Introduce or increase the dosage of Steroids(intravenous infusion) within the last 1 week.
?Introduce or increase the dosage of Steroids(oral, enema, suppository) within the last 2 weeks.
?Introduce or increase the dosage of Mesalazine Sulfasalazine(oral, enema, suppository) within the last 4 weeks.
?Introduce or increase the dosage of Cyclosporine, Tacrolimus, Methotrexate within the last 8 weeks.
?Introduce or increase the dosage of Azathioprine, 6-mercaptopurine within the last 12 weeks.
?Introduce of Infliximab, Adalimumab, GMA, LCAP within the last 3 months.
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Ulcerative colitis
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Intervention(s)
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Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks
GMA will be administrated 10 times
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Primary Outcome(s)
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Response rate at week 10
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Secondary Outcome(s)
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?Remission rate at week 10 (DAI =< 2)
?Endoscopic remission rate
?Reduction in partial DAI score at week 2, week 6, week 10
?The incidence of adverse events
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Source(s) of Monetary Support
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none
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Ethics review
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Status:
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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