UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003128 |
|---|---|
| Receipt number | R000003788 |
| Scientific Title | Supplemental treatment of rheumatoid arthritis with natural milk antibodies against enteromicrobes and their toxins |
| Date of disclosure of the study information | 2010/02/15 |
| Last modified on | 2010/02/01 19:18:40 |
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Basic information
Public title
Supplemental treatment of rheumatoid arthritis with natural milk antibodies against enteromicrobes and their toxins
Acronym
Supplemental treatment of rheumatoid arthritis with natural milk antibodies
Scientific Title
Supplemental treatment of rheumatoid arthritis with natural milk antibodies against enteromicrobes and their toxins
Scientific Title:Acronym
Supplemental treatment of rheumatoid arthritis with natural milk antibodies
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Environmental factors, particularly bacteria in the gastrointestinal tract, are considered to involve in the pathogenesis of rheumatoid arthritis (RA). We aim to evaluate the eventual disease modifying effect in RA of whey protein containing natural milk antibodies against enteromicrobes and their toxins.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
ACR response criteria, EULAR response criteria using the 28-joints count disease activity score using ESR (DAS28-ESR) and Evaluation Points, a modified American College of Rheumatology (ACR) criteria
Key secondary outcomes
General health, for conditions such as GI status, appetite, weight gain, activities of daily living (ADL), anemia, fatigue, sleep and daily physical feeling.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Patients receive milk antibody administration for three months with the concurrent treatments. Some patients receive repeated milk antibody treatment after structured treatment interruption.
Interventions/Control_2
Patients receive only concurrent treatments.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with RA whose disease activity was uncontrolled by authentic medications due to drug resistance or complications and risk factors.
Key exclusion criteria
Patients with milk allergy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kou Katayama |
Organization
Katayama Orthopedic Rheumatology Clinic
Division name
Department of orthopedic surgery
Zip code
Address
Toyooka 13-4-5-17, Asashikawa, Hokkaido, Japan
TEL
0166-39-1155
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kou Katayama |
Organization
Katayama Orthopedic Rheumatology Clinic
Division name
Department of orthopedic surgery
Zip code
Address
Toyooka 13-4-5-17, Asashikawa, Hokkaido, Japan
TEL
0166-39-1155
Homepage URL
kou@kata-rheum.or.jp
Sponsor or person
Institute
Asama Chemical Co. Ltd.,
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Chondrex Inc.
Name of secondary funder(s)
None
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
片山整形外科リウマチ科クリニック（北海道）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 02 | Month | 15 | 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
| 2007 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 02 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 02 | Day |
Last modified on
| 2010 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003788
