UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005724 |
|---|---|
| Receipt number | R000006767 |
| Scientific Title | Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome endocrinopathy (ROSE Trial) |
| Date of disclosure of the study information | 2011/06/29 |
| Last modified on | 2012/07/12 13:20:17 |
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Basic information
Public title
Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome endocrinopathy (ROSE Trial)
Acronym
Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome endocrinopathy (ROSE Trial)
Scientific Title
Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome endocrinopathy (ROSE Trial)
Scientific Title:Acronym
Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome endocrinopathy (ROSE Trial)
Region
| Japan |
Condition
Condition
rheumatoid arthritis complicated by sjogren's syndrome
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of
abatacept in patients with
rheumatoid arthritis (RA) and Sjogren's syndrome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Remission at year 1,defined as a SDAI of less than 3.3
Key secondary outcomes
1) CRP,ESR,RF
2) Saxon test
3) salivary glands MRI
4) Immunoglobulins, the anti-SS-A/Ro antibody, the anti-SSB/La antibody
5) Patients VAS
6) Joint Radiographic assessment
7) Joint Magnetic resonance imaging assessment
8) ultrasonography
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)20 years-old<
2)Rheumatoid arthritis patinets according to criteria of ACR1987 or ACR/EULAR2010
3)Sjogren's syndrome patients according to criteria of the 1999
Ministry of Health and Welfare
4)Patients with subjective sicca symptoms
5) Patients who give a full consent to this study
Key exclusion criteria
1)contraindicated patients
2)patients over 75 years of age
3)Patients with a total leukocyte count of 3000/mm3 or less,
4)pregnant women or lactating mothers, women with child-bearing potential and patients wishing to become pregnant during this study
5)patients under 20 years of age
6)patients who had received any drugs for treatment of Sjogren's syndrome, including cevimeline hydrochloride hydrate, anetholtrithion, and pilocarpine hydrochloride within 4 weeks prior to the study treatment
7) patients with any concurrent serious disorders of the liver, kidney or hematopoietic organs
8) anti centromere antibody positive
9)Patients who are inadequate by investigator's decision.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Sumida |
Organization
Graduate School of Comprehensive Human Science,University of Tsukuba
Division name
Division of Clinical Immunology,Mejor of Advanced Biochemical Applications
Zip code
Address
2-1-1,amakubo,Tsukuba-city,Ibaraki,305-8576,Japan
TEL
029-853-3900
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isao Matsumoto |
Organization
Graduate School of Comprehensive Human Science,University of Tsukuba
Division name
Division of Clinical Immunology,Mejor of Advanced Biochemical Applications
Zip code
Address
2-1-1,amakubo,Tsukuba-city,Ibaraki,305-8576,Japan
TEL
029-853-3900
Homepage URL
rinshokenkyu@un.tsukuba.ac.jp
Sponsor or person
Institute
Division of Clinical Immunology,
Major of Advanced Biochemical Applications, Graduate School of Comprehensive Human Science,University of Tsukuba Takayuki Sumida
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
産業医科大学（福岡県）、長崎大学（長崎県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To assess the efficacy and safety of
abatacept in patients with
rheumatoid arthritis (RA) and Sjogren's syndrome.
Management information
Registered date
| 2011 | Year | 06 | Month | 05 | Day |
Last modified on
| 2012 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006767
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
