UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005689
Receipt No. R000006728
Scientific Title GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial
Date of disclosure of the study information 2011/05/31
Last modified on 2016/02/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial
Acronym Effect of GMA early combined with azathioprine on induction of remission in active Crohn's disease
Scientific Title GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine vs Infliximab plus azathioprine for induction of remission in active Crohn's disease : an open randomized trial
Scientific Title:Acronym Effect of GMA early combined with azathioprine on induction of remission in active Crohn's disease
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficacy and safety of GMA (Granulocyte and Monocyte Adsorption) early combined with azathioprine in comparison with Infliximab plus azathioprine, for induction of remission in active Crohn's disease, in a multicenter, prospective, randomized, controlled, non-blinded study
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Remission (CDAI<150) rate at the end of the study (intensive GMA plus azathioprine: at week 7, Infliximab plus azathioprine: at week 8)
Key secondary outcomes 1) Clinical response (70 points reduction in their CDAI)
2) Reduction in CRP
3) Cytokine profile in CD4 positive T cell
4) Cumulative non-relapse rate
5) Safety assessment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Patients in the combination therapy of GMA with azathioprine receive intensive GMA (twice per week, total 10 sessions) and oral azathioprine.
Interventions/Control_2 Patients in the combination therapy of Infliximab and azathioprine receive infusion of IFX (at week 0, 2, 6) and oral azathioprine.
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients with moderately to severely active Crohn's disease (CDAI 220-450)
2) Adequate peripheral venous access to allow for completion of GMA
3) Able to provide informed consent
Key exclusion criteria 1) Patients with granulocyte count of equal to or less than 2,000/mm3
2) Patients with serious infectious disease
3) Patients with serious heart disease
4) Patients with serious kidney disease
5) Patients with hypotension (less than maximum blood pressure 80mmHg)
6) Patients who are pregnant or have the possibility of pregnancy
7) Patients with serious dehydration, hypercoagulability, serious anemia (under haemoglobin 8g/dl)
8) Patients with malignancy
9) Patients with Short-bowel syndrome
10) Patients with permanent ostomy
11) Patients with external fistula, including poor control of anal fistula
12) Patients with total colectomy and subtotal colectomy
13) Patients with intestinal stenosis to cause intestinal obstruction
14) Patients with serious extraintestinal complication
15) Patients who had undergone previous immunosuppressive therapies
16) Patients who had undergone previous biologic therapies
17) Patients who had introduced or increased the dosage of Steroids (intravenous Infusion, oral, enema, suppository) within the last 2 weeks
18) Patients who had introduced or increased the dosage of Metronidazole within the last 2 weeks
19) Patients who had introduced or increased the dosage of Mesalazine sulfasalazine (oral, enema, suppository) within the last 4 weeks
20) Patients who had introduced or increased the dosage of elemental diet within the last 4 weeks
21) Patients who had undergone the operation (except replace of Seton) for anal fistula within 4 weeks
22) Patients who had undergone total parental nutrition with in last 4 weeks
23) Patients who had undergone the operation, including strictureplasty, for bowel within the last 12 weeks
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Nakase
Organization Kyoto University Hospital
Division name Division of Endoscopic Medicine
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL 075-751-4319
Email hiropy_n@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minoru Matsuura
Organization Kyoto University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL 075-751-4319
Homepage URL
Email minomats@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Kyoto University Hospital
Institute
Department

Funding Source
Organization JIMRO Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
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 京都大学医学部附属病院(京都府)
大阪府済生会中津病院(大阪府)
大津日本赤十字病院(滋賀県)
北野病院(大阪府)
神戸市立医療センター中央市民病院(兵庫県)
神戸市立医療センター西市民病院(兵庫県)
西神戸医療センター(兵庫県)

Other administrative information
Date of disclosure of the study information
2011 Year 05 Month 31 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 17 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 Day
Last follow-up date
2013 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2014 Year 05 Month 01 Day
Date analysis concluded
2014 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 05 Month 31 Day
Last modified on
2016 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006728

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.