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 |
Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome endocrinopathy (ROSE Trial)
Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome endocrinopathy (ROSE Trial)
Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome endocrinopathy (ROSE Trial)
Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome endocrinopathy (ROSE Trial)
Japan |
rheumatoid arthritis complicated by sjogren's syndrome
Clinical immunology |
Others
NO
To assess the efficacy and safety of
abatacept in patients with
rheumatoid arthritis (RA) and Sjogren's syndrome.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
Remission at year 1,defined as a SDAI of less than 3.3
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
Observational
20 | years-old | <= |
75 | years-old | > |
Male and Female
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
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.
30
1st name | |
Middle name | |
Last name | Takayuki Sumida |
Graduate School of Comprehensive Human Science,University of Tsukuba
Division of Clinical Immunology,Mejor of Advanced Biochemical Applications
2-1-1,amakubo,Tsukuba-city,Ibaraki,305-8576,Japan
029-853-3900
1st name | |
Middle name | |
Last name | Isao Matsumoto |
Graduate School of Comprehensive Human Science,University of Tsukuba
Division of Clinical Immunology,Mejor of Advanced Biochemical Applications
2-1-1,amakubo,Tsukuba-city,Ibaraki,305-8576,Japan
029-853-3900
rinshokenkyu@un.tsukuba.ac.jp
Division of Clinical Immunology,
Major of Advanced Biochemical Applications, Graduate School of Comprehensive Human Science,University of Tsukuba Takayuki Sumida
non
Self funding
NO
産業医科大学(福岡県)、長崎大学(長崎県)
2011 | Year | 06 | Month | 29 | Day |
Unpublished
Open public recruiting
2011 | Year | 05 | Month | 09 | Day |
2011 | Year | 06 | Month | 01 | Day |
To assess the efficacy and safety of
abatacept in patients with
rheumatoid arthritis (RA) and Sjogren's syndrome.
2011 | Year | 06 | Month | 05 | Day |
2012 | Year | 07 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006767