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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006889
Receipt No. R000008136
Scientific Title Evaluation of Concomitant Infliximab and Granulocyte/ Monocyte Adsorption Apheresis in Crohn's disease Patients who lose Response to 5mg/kg/dose Infliximab Therapy
Date of disclosure of the study information 2012/01/01
Last modified on 2014/05/08

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Basic information
Public title Evaluation of Concomitant Infliximab and Granulocyte/ Monocyte Adsorption Apheresis in Crohn's disease Patients who lose Response to 5mg/kg/dose Infliximab Therapy
Acronym Infliximab-GMA Effect of Loss of Response; INGRESS study
Scientific Title Evaluation of Concomitant Infliximab and Granulocyte/ Monocyte Adsorption Apheresis in Crohn's disease Patients who lose Response to 5mg/kg/dose Infliximab Therapy
Scientific Title:Acronym Infliximab-GMA Effect of Loss of Response; INGRESS study
Region
Japan

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

Objectives
Narrative objectives1 Aiming to conduct a randomize controlled trial for comparing the efficacy and safety between the concomitant infliximab (5mg/kg/dose) and Granulocyte/ Monocyte Adsorption apheresis (GMA) and the infliximab (10mg/kg/dose) in patients with Crohn's disease who lose response to standard (5mg/kg/dose) infliximab therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Change in CDAI at 24 weeks relative to the base-line
Key secondary outcomes (1) CDAI scores at each observation period
(2) The CDAI 50 points improvement ratio (CR50) at each observation period
(3) Remission (CDAI<150) induction rate at each observation period
(4) Change in CDAI at each observation period relative to the base-line.
(5) The CRP values at each observation period
(6) Change in CRP and ESR at each observation period relative to the base-line.
(7) Change in secretions of the various peripheral cytokine at each observation period relative to the base-line.
(8) Endoscopic and/or barium enema evaluation comparing between pre- (-8 to 0 week) and post- (24 to 28 weeks) allocation
(9) Incidence of adverse events
etc.

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 NO
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 Device,equipment
Interventions/Control_1 Repeat 3 sets of the concomitant therapy with IFX and GMA. Each set is consisted from a single 5mg/kg/dose of infliximab infusion plus 3 times of weekly GMA at 5, 6, and 7 weeks after IFX infusion.
Interventions/Control_2 Repeat 3 infusions of the 10mg/kg/dose infliximab in 8 weeks interval.
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
16 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria (1) Patient of ileo-colitis or colitis type Crohn's disease
(2) Patients with Crohn's disease showing temporary clinical remission (CDAI less than 150) in response to 5mg/kg/dose infliximab therapy but poorly responding (CDAI over 175 and increase more than 50 points during the recent 4 weeks) to subsequent maintenance infliximab therapy (5mg/kg/dose, every 8 weeks).
(3) Patients age from 16 to 74.
(4) Patients considered being capable for venous catheter insertion
Key exclusion criteria (1) Cases that granulocyte count below 2000/mm3
(2) Cases that complication by infection present or suspected
(3) Patients with severe heart disease
(4) Patients with severe kidney disease
(5) Patients with hypotension (Systolic blood pressure less than 80mmHg)
(6) Patients willing or being pregnant (or lactation).
(7) Patient with severe dehydration and/or hyper-viscosity. Patients with severe anemia (Hb <8g/dL)
(8) Patients with malignant tumor
(9) Patients with colostomy
(10) Patients with uncontrollable external-fistulas.
(11) Patients with intestinal stenosis.
(12) Patients with severe extra-intestinal complications.
(13) Patients with short bowel syndrome.
(14) Patients after total colectomy.
(15) Patients who have been treated with corticosteroids (iv, po, or topical) within 2 weeks.
(16) Patients who have treated with intravenous hyperalimentation (IVH) within 4 weeks.
(17) Patients who have been given more than 1,200kcal of elemental nutrition within 4 weeks.
(18) Patients who have episode of starting or increasing dosage of thioprine within 8 weeks.
(19) Patients who do not submit informed consent
(20) Patients who have been treating with non-approval therapy and/or enrolling other clinical trials.
(21) Other patients judged as inappropriate by the physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiro Nakamura
Organization Hyogo College of Medicine
Division name Department of Lower Gastroenterology
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 Department of Lower Gastroenterology
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo Pref.
TEL 0798456662
Homepage URL
Email kebe@hyo-med.ac.jp

Sponsor
Institute Department of Lower Gastroenterology, Hyogo College of Medicine
Institute
Department

Funding Source
Organization Department of Lower Gastroenterology, Hyogo College of Medicine
Organization
Division
Category of Funding Organization Self funding
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 青山内科クリニック(兵庫)、生駒クリニック(兵庫)、生駒診療所(奈良)、生駒内科・消化器内科クリニック(大阪府)、錦秀会インフュージョンクリニック(大阪府)、大阪市立大学(大阪府)、加古川西市民病院(兵庫県)、神戸海星病院(兵庫県)、済生会中津病院(大阪府)、市立伊丹病院(兵庫県)、西下胃腸病院(大阪府)、姫路赤十字病院(大阪府)

Other administrative information
Date of disclosure of the study information
2012 Year 01 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 11 Month 05 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2013 Year 07 Month 01 Day
Date of closure to data entry
2013 Year 07 Month 01 Day
Date trial data considered complete
2013 Year 10 Month 01 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 12 Month 14 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=R000008136

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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