Unique ID issued by UMIN | UMIN000032485 |
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Receipt number | R000037045 |
Scientific Title | efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease |
Date of disclosure of the study information | 2018/05/08 |
Last modified on | 2020/05/13 22:41:14 |
efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease
postoperative early adalimumab or immunomodulator in CD study
efficacy of early adalimumab or immunomodulator on postoperative remission maintenance in patients with Crohn's disease
postoperative early adalimumab or immunomodulator in CD study
Japan |
Cron's disease
Gastroenterology |
Others
NO
the comparison of long-term efficacy with postoperative early adalimumab or immunoregulatory in Crohn disease
Safety,Efficacy
Confirmatory
endoscopic remission rate of 18 months after surgery
clinical remission rate, negative CRP, trough level of anti-TNF agents, maintenance rate of the therapy, re-surgery rate of 18 months after surgery
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
2
Treatment
Medicine |
adalimumab
azathiopurine
20 | years-old | <= |
70 | years-old | > |
Male and Female
CD patients with intestinal resection for active CD lesion within 3 months
stoma
without intestinal resection
20
1st name | Akihiro |
Middle name | |
Last name | Yamada |
Sakura medical center, Toho university
gastroenterology
285-0841
564-1,shimoshizu, sakura,chiba
043-462-8811
taro-dog@sakura.med.toho-u.ac.jp
1st name | Akihiro |
Middle name | |
Last name | Yamada |
Sakura medical center, Toho university
gastroenterology
285-0841
564-1,shimoshizu, sakura,chiba
043-462-8811
taro-dog@sakura.med.toho-u.ac.jp
Sakura medical center, Toho university
none
Self funding
Sakura medical center, Toho university
564-1,shimoshizu, sakura, chiba
043-462-8811
taro-dog@sakura.med.toho-u.ac.jp
NO
2018 | Year | 05 | Month | 08 | Day |
https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037045
Published
https://www.longdom.org/open-access/efficacy-of-early-adalimumab-or-immunomodulator-on-postoperative
47
At 78 weeks, endoscopic remission was confirmed in 5/16 patients in the AZA group (31.2%) and 7/12 patients in the ADA group (58.3%) (p=0.24) in the intention-to-treat population. In the per-protocol population (19 patients with evaluable images), remission was recorded in 3/9 (33.3%) patients in the AZA and 7/10 (70.0%) in the ADA group.
2020 | Year | 05 | Month | 13 | Day |
There were no statistical difference between groups regarding baseline including sm- oking status, previous resections, CD phenotype, previous perianal disease, and previous drug exposure
Atotal 47 patients were entered into the study.Eight patients (17.1%) were excluded during screening (five did not fulfill
the selection criteria, and three patients were lost to follow-up), leaving 39 eligible patients; 20 patients were randomized to the AZA group and 19 to the ADA group.
Sixteen (41.0%) patients withdrew from the trial before the 78-month end point, although 4 (10.2%) of these patients withdrew only after clinical recurrence. The reasons for withdrawal are detailed in Table 3. A total of 12 adverse events were observed, the adverse event rates were similar across treatment groups (p=1.00). Six patients were withdrawn due to severe adverse events (AZA; 5, vs ADA; 0, p=0.04).
The primary endpoint was the rate of remission of CD in the endoscopy performed at Week 78, the evidence based on the Rutgeerts score.
The secondary endpoints included the percentages of clinical remission (Crohn's Disease Activity Index, CDAI less than 150) after 78 weeks of therapy, as well as negative titer in activity markers such as fecal calprotectin less than 300 mg/g, serum C-reactive protein less than 0.3 mg/dl at Weeks 78. Adverse events and surgical requirements were evaluated until Weeks 78.
Completed
2015 | Year | 01 | Month | 01 | Day |
2015 | Year | 05 | Month | 01 | Day |
2015 | Year | 01 | Month | 01 | Day |
2018 | Year | 12 | Month | 31 | Day |
2018 | Year | 05 | Month | 07 | Day |
2020 | Year | 05 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037045
Research Plan | |
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Registered date | File name |
2020/05/13 | ADA AZA(様式3)研究実施計画書.doc |
Research case data specifications | |
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Registered date | File name |
2020/05/13 | ADA AZA(様式2)研究実施計画の概要.xls |
Research case data | |
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Registered date | File name |
2020/05/13 | CD ADA IM randomize.xls |