Unique ID issued by UMIN | UMIN000015068 |
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Receipt number | R000015858 |
Scientific Title | An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis |
Date of disclosure of the study information | 2014/09/05 |
Last modified on | 2017/04/18 14:30:35 |
An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis
An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis
An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis
An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis
Japan |
Ulcerative colitis
Gastroenterology |
Others
NO
To compare clinical remission rates, clinical response rates between patients with intractable ulcerative colitis treated with GMA or Infliximab.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Response rate at week 10
・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
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine | Device,equipment |
Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks
GMA will be administrated 10 times
20 | years-old | <= |
Not applicable |
Male and Female
・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
・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.
150
1st name | |
Middle name | |
Last name | Shinji Tanaka |
Hiroshima University Hospital
Department of Endoscopy
1-2-3 kasumi minami-ku Hiroshima city
082-257-5538
colon@hiroshima-u.ac.jp
1st name | |
Middle name | |
Last name | Yoshitaka Ueno |
Hiroshima University Hospital
Department of Endoscopy
1-2-3 kasumi minami-ku Hiroshima city
082-257-5193
yueno@hiroshima-u.ac.jp
Hiroshima University Hospital, Department of Endoscopy
none
Self funding
NO
県立広島病院(広島県)、広島記念病院(広島県)、広島市民病院(広島県)、広島赤十字病院(広島県)、安佐市民病院(広島県)、済生会呉病院(広島県)、県立安芸津病院(広島県)、呉医療センター(広島県)、中国労災病院(広島県)、東広島医療センター(広島県)、JA広島総合病院(広島県)、広島西医療センター(広島県)、JA尾道総合病院(広島県)、呉共済病院(広島県)、木村胃腸科病院(広島県)
2014 | Year | 09 | Month | 05 | Day |
Unpublished
Completed
2014 | Year | 07 | Month | 03 | Day |
2014 | Year | 09 | Month | 05 | Day |
2014 | Year | 09 | Month | 05 | Day |
2017 | Year | 04 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015858
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