Unique ID issued by UMIN | UMIN000007514 |
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Receipt number | R000007915 |
Scientific Title | Phase ll Study of Postoperative Adalimumab Maintenance Therapy for Crohn's Disease Recurrence |
Date of disclosure of the study information | 2012/03/15 |
Last modified on | 2016/11/16 08:57:35 |
Phase ll Study of Postoperative Adalimumab Maintenance Therapy
for Crohn's Disease Recurrence
PAD study
Phase ll Study of Postoperative Adalimumab Maintenance Therapy
for Crohn's Disease Recurrence
PAD study
Japan |
Crohn's disease
Gastroenterology | Gastrointestinal surgery |
Others
NO
To evaluate the efficacy and safety of postoperative Adalimumab maintenance therapy
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Endoscopic recurrence rete at the anastomotic site after 1 year.
Endoscopic recurrence rete at the anastomotic site
Clinical Recurrence rate
Crohn's disease activity index point (CDAI)
Recurrence-free survival time.
Time to treatment failure.
Rate of adverse event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Adalimumab (HUMIRA 40mg for SC Injection)
Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29.
20 | years-old | <= |
Not applicable |
Male and Female
(1) Clinically and histopathologically confirmed Crohn's disease
(2) Patients who underwent enterectomy and/or enteroanastomosis for primary intestinal lesions (stenosis, fistulae, abscess).
(3) Prior therapies are no object.
(4) Written informed concent
(5) Adequate organ function
(1) Uncontrolled infection
(2) Confirmed opportunistic infection diseases within 6 months
(3) Tuberculosis or a history of it
(4) most positive tuberculin skin test
(5) Active hepatitis B, C or a history of hepatitis C
(6) Confirmed HIV infection
(7) Demyelinating disease or a history of it
(8) History of lymphoproliferative disorder, or suspicion of lymphoproliferative disorder or splenomegaly
(9) Lupus syndrome, and positive anti-dsDNA antibody
(10) malignant tumor
(11) Clinically abnormal electrocardiogram or cardiovascular disease.
(12) Severe pulmonary disease
(13) Interstitial pneumonia or pulmonary fibrosis or a history of those
(14) Severe hepatic disease
(15) Severe renal failure
(16) Severe drug allergies
(17) Bowel obstraction or bowel paresis
(18) Severe or uncontrollable complications (diabetes mellitus, hypertention, diarrhea, electrolyte abnormality, etc.)
(19) Psychiatric disorder, central nervous system damage, cerebrovascular diseases
(20) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers.
(21) Not appropriate for the study at the physician's assessment.
25
1st name | |
Middle name | |
Last name | Goro Nakayama |
Nagoya University Gradeate School of Medicine
Department of Gastroenterology
65, Tsurumai-cho, Showa-ku, Nagoya- city, Aichi-prefecture
(81)52-744-2250
goro@med.nagoya-u.ac.jp
1st name | |
Middle name | |
Last name | Norifumi Hattori |
Nagoya University Gradeate School of Medicine
Department of Gastroenterology
65 Tsurumai, Showa-ku, Nagoya
(81)52-744-2250
http://www.med.nagoya-u.ac.jp/surgery2/scientific/ccog/
norifumi@med.nagoya-u.ac.jp
Nagoya University Gradeate School of Medicine
Department of Gastroenterology
none
Self funding
NO
2012 | Year | 03 | Month | 15 | Day |
Unpublished
Completed
2011 | Year | 11 | Month | 14 | Day |
2012 | Year | 01 | Month | 01 | Day |
2019 | Year | 01 | Month | 01 | Day |
2012 | Year | 03 | Month | 15 | Day |
2016 | Year | 11 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007915
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