UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase ll Study of Postoperative Adalimumab Maintenance Therapy for Crohn's Disease Recurrence
Title of the study (Brief title)	PAD study
Region	Japan

Condition
Condition	Crohn's disease
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of postoperative Adalimumab maintenance therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Endoscopic recurrence rete at the anastomotic site after 1 year.
Key secondary outcomes	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

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(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
Key exclusion criteria	(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.
Target sample size	25

Research contact person
Name of lead principal investigator	Goro Nakayama
Organization	Nagoya University Gradeate School of Medicine
Division name	Department of Gastroenterology
Address	65, Tsurumai-cho, Showa-ku, Nagoya- city, Aichi-prefecture
TEL	(81)52-744-2250
Email	goro@med.nagoya-u.ac.jp

Public contact
Name of contact person	Norifumi Hattori
Organization	Nagoya University Gradeate School of Medicine
Division name	Department of Gastroenterology
Address	65 Tsurumai, Showa-ku, Nagoya
TEL	(81)52-744-2250
Homepage URL	http://www.med.nagoya-u.ac.jp/surgery2/scientific/ccog/
Email	norifumi@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University Gradeate School of Medicine Department of Gastroenterology
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 03 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 11 Month 14 Day
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date	2019 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 03 Month 15 Day
Last modified on	2016 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007915