UMIN-CTR Clinical Trial

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

ulcerative colitis

Classification by specialty

Medicine in general	Hepato-biliary-pancreatic medicine	Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

Lower Gastroenterology, Hyogo College of Medicine

Institute

Department

Personal name

Organization

Lower Gastroenterology, Hyogo College of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Department of Gastroenterology, Osaka City University and Department of Gastroenterology, Osaka Medical College

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2011

Year

03

Month

31

Day

Last modified on

2014

Year

05

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006360