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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003128
Receipt No. 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

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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
Email

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
Email kou@kata-rheum.or.jp

Sponsor
Institute Asama Chemical Co. Ltd.,
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003788

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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