Unique ID issued by UMIN | UMIN000019066 |
---|---|
Receipt number | R000022048 |
Scientific Title | An open label randomized controlled trial of combination therapy of Adalimumab and GMA for intractable ulcerative colitis |
Date of disclosure of the study information | 2015/09/18 |
Last modified on | 2015/09/18 16:23:30 |
An open label randomized controlled trial of combination therapy of Adalimumab and GMA for intractable ulcerative colitis
An open label randomized controlled trial of combination therapy of Adalimumab and GMA for intractable ulcerative colitis
An open label randomized controlled trial of combination therapy of Adalimumab and GMA for intractable ulcerative colitis
An open label randomized controlled trial of combination therapy of Adalimumab and GMA for intractable ulcerative colitis
Japan |
Ulcerative colitis
Gastroenterology |
Others
NO
To clarify the efficacy and safety of combination of Adalimumab and GMA
Efficacy
Confirmatory
Pragmatic
Not applicable
Partial Mayo score remission rate at week 8
Partial Mayo score response rate, endoscopic remission at week 8
Partial Mayo score remission, response rate at week 2,4,6,52
Safety until week 52
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine | Device,equipment |
Administration of Adalimumab 160 mg at baseline, 80 mg at 2 weeks and 40 mg every 2 weeks.
In addition to Adalimumab Therapy, co-treatment of GMA 3times a week up to 2 weeks
20 | years-old | <= |
Not applicable |
Male and Female
Patients with moderate to severe activity
Moderate or severe patients with UC with steroid-dependent or steroid-refractory
Adalimumab contraindication
1)Patients with severe infection (Sepsis, etc)
2)Patients with active tuberculosis
3)Patients with history of hypersensitivity to any of the other ingredients of Adalimumab
4)Patients with demyelinating disease (Multiple sclerosis, etc) or with history of demyelinating disease
5)Patients with congestive heart failure
GMA contraindication
1)Granulocyte count is equal to or less than 2000/ mm3
2)Serious infectious disease
58
1st name | |
Middle name | |
Last name | Ken Takeuchi |
Sakura Medical center, Toho University
Internal Medicine
564-1,Shimoshizu,Sakura-city,Chiba
043-462-8811
ken.takeuchi@sakura.med.toho-u.ac.jp
1st name | |
Middle name | |
Last name | Ken Takeuchi |
Sakura Medical center, Toho University
Internal Medicine
564-1,Shimoshizu,Sakura-city,Chiba
043-462-8811
ken.takeuchi@sakura.med.toho-u.ac.jp
Sakura Medical Center,Toho university
None
Self funding
None
None
NO
東邦大学医療センター佐倉病院
2015 | Year | 09 | Month | 18 | Day |
Unpublished
Preinitiation
2015 | Year | 07 | Month | 15 | Day |
2015 | Year | 09 | Month | 25 | Day |
2015 | Year | 09 | Month | 18 | Day |
2015 | Year | 09 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022048
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |