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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005358
Receipt No. R000006360
Scientific Title Rapid LeukocyAPheresis InDuction for Ulcerative Colitis
Date of disclosure of the study information 2011/04/01
Last modified on 2014/05/08

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Basic information
Public title Rapid LeukocyAPheresis InDuction for Ulcerative Colitis
Acronym RAPID-UC
Scientific Title Rapid LeukocyAPheresis InDuction for Ulcerative Colitis
Scientific Title:Acronym RAPID-UC
Region
Japan

Condition
Condition ulcerative colitis
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of early administration of LCAP performed after 3 days steroid use compared with the general timing LCAP administration after 2 weeks steroid use for active ulcerative colitis.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes The primary outcome is the improvement of Mayo score obtained after 6th LCAP. Mayo score is taken before (within 2 weeks of starting LCAP) and after 6th LCAP. Partial-Mayo score is taken at every visit and/or whenever the score has to be taken without endoscopic evaluation.
Key secondary outcomes The secondary outcome is the Lichtiger's clinical activity index taken before (within 2 weeks of starting LCAP) and after 6th LCAP.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 LCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 3 days.
Interventions/Control_2 LCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 14 days.
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
12 years-old <
Age-upper limit
81 years-old >
Gender Male and Female
Key inclusion criteria The inclusion criteria in this study are as follows. Patients met all the criteria.
1)Patients with moderate to severe UC in active stage according to the UC severity criteria established by the Research Committee of Specified Diseases/Intractable Inflammatory Bowel Diseases of Ministry of Health, Labour and Welfare.
2)Patients with serum C-reactive protein level of 1.0mg/dL or higher.
3)Patients not having received any corticosteroids therapy, or having received the corticosteroids therapy less than 0.6mg/kg/day or 30mg/day or less, within the past 2 weeks.
Key exclusion criteria 1) Patients with proctitis
2) Patients with chronic persistent UC
3) Patients having consecutively received corticosteroids therapy of 5mg/day or more, for more than 3 months
4) Patients having consecutively received corticosteroids enema therapy for more than 3 months
5) Patients with either white blood cell count of less than 3,000/mm3, or hemoglobin level of less than 10g/dL, or platelet count of less than 100,000/mm3
6) Patients who are younger than 12 years old or who are older than 80 years old.
7) Patients determined to be inappropriate for this study by the investigators
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiro Nakamura
Organization Hyogo College of Medicine
Division name Lower GI disease
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo Pref.
TEL 0798-45-6660
Email shiro@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Fukunaga
Organization Hyogo College of Medicine
Division name Lower GI disease
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo Pref.
TEL 0798-45-6662
Homepage URL
Email kebe@hyo-med.ac.jp

Sponsor
Institute Lower Gastroenterology, Hyogo College of Medicine
Institute
Department

Funding Source
Organization Lower Gastroenterology, Hyogo College of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Gastroenterology, Osaka City University and Department of Gastroenterology, Osaka Medical College
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2011 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2011 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2013 Year 12 Month 31 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 03 Month 31 Day
Last modified on
2014 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006360

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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