UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006889 |
|---|---|
| Receipt number | 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 15:15:31 |
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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
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
kebe@hyo-med.ac.jp
Sponsor or person
Institute
Department of Lower Gastroenterology, Hyogo College of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008136
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