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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005724
Receipt No. 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

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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
Email

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
Email rinshokenkyu@un.tsukuba.ac.jp

Sponsor
Institute Division of Clinical Immunology,
Major of Advanced Biochemical Applications, Graduate School of Comprehensive Human Science,University of Tsukuba Takayuki Sumida
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006767

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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