UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006882 |
|---|---|
| Receipt number | R000008130 |
| Scientific Title | Evaluation of Concomitant Adalimumab and Cytapheresis in Patients who lose Response to Adalimumab Therapy |
| Date of disclosure of the study information | 2012/01/01 |
| Last modified on | 2014/05/08 15:13:27 |
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Basic information
Public title
Evaluation of Concomitant Adalimumab and Cytapheresis in Patients who lose Response to Adalimumab Therapy
Acronym
Supplement cytapheresis improve response of adalimumab; SAPPHIRE study
Scientific Title
Evaluation of Concomitant Adalimumab and Cytapheresis in Patients who lose Response to Adalimumab Therapy
Scientific Title:Acronym
Supplement cytapheresis improve response of adalimumab; SAPPHIRE study
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aiming to evaluate the efficacy and safety of concomitant adalimumab and Cytapheresis (GMA) in patients with Crohn's disease who lose response to adalimumab therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Remission rate in week12 (remission:CDAI<150)
Key secondary outcomes
Time course of CDAI during each observation period
Time course of CRP during each observation period
Mucosal healing rate at 12 weeks
Incidence of adverse events
etc.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Adalimumab therapy (40 mg/dose, every other week) combined with Granulocyte/ Monocyte Apheresis (GMA), once weekly for 5 comsecutive weeks. If responses are noted, GMA is applied for another 5 sessions (once weekly).
Interventions/Control_2
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Crohn's disease having large bowel lesions showing temporary clinical remission (CDAI less than 150) in response to uncombined adalimumab therapy but poorly responding (CDAI over 150) to subsequent maintenance adalimumab therapy (40 mg/dose, every other week)
Key exclusion criteria
(1) Cases that are contraindicated for GMA
Granulocyte count below 2000/mm3
Complication by infection present or suspected
(2) Patients with small intestine type Crohn's disease (no large bowel lesion)
(3) Patients with colostomy
(4) Patients younger than 15
(5) Patients who do not submit informed consent
(6) Patients with malignant tumor
(7) Patients within 3 months of post intestinal surgery
(8) Patients with short bowel syndrome
(9) Other patients judged as inappropriate by the physician
Target sample size
20
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 | Fukunaga, Ken |
Organization
Hyogo College of Medicine
Division name
Department of Lower Gastroenterology
Zip code
Address
1-1 Mukogawa, Nishinomiya, Hyogo Pref.
TEL
0798-45-6662
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
Other related organizations
Co-sponsor
Hyogo College of Medicine (Hyogo, Japan), Osaka City Univ. (Osaka, Japan), Osaka Medical College (Osaka, Japan), Kyoto Univ. (Kyoto, Japan), Shiga University of Medical Science (Shiga, Japan)
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
兵庫医科大学（兵庫）、大阪市立大学（大阪）、大阪医科大学（大阪）、京都大学（京都）、滋賀医科大学（滋賀）
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 | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 13 | 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=R000008130
