Unique ID issued by UMIN | UMIN000016273 |
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Receipt number | R000018879 |
Scientific Title | Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome Endocrinopathy (ROSE II Trial) |
Date of disclosure of the study information | 2015/01/20 |
Last modified on | 2022/07/27 13:14:25 |
Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome Endocrinopathy (ROSE II Trial)
Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome syndrome Endocrinopathy (ROSE II Trial)
Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome Endocrinopathy (ROSE II Trial)
Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome syndrome Endocrinopathy (ROSE II Trial)
Japan |
Rheumatoid Arthritis complicated with Sjogren's syndrome
Clinical immunology |
Others
NO
Usefulness, including remission rate by SDAI, Saxon test, salivary gland image assessment, anti-SS-A/Ro antibody, anti-SS-B/La antibody, IgG, improvement of patient VAS, ESSDAI, ESSPRI, articular X-ray assessment, articular MRI assessment, articular ultrasonography, and the incidence of adverse reactions during 12 months of abatacept administration to patients with rheumatoid arthritis (RA) complicated with Sjogren's syndrome (SS) will be verified.
Safety,Efficacy
Exploratory
Pragmatic
The percentage of patients who achieved clinical remission by SDAI at 52 weeks
1) CRP, ESR, RF
2) Saxon's test
3) MRI of parotid glands
4) anti-SS-A/SS-B antibody, IgG
5) patients'VAS
6) Joint X-P
7) Joint MRI
8) Joint ultrasonography
9) ESSDAI
10) ESSPRI
Observational
20 | years-old | <= |
75 | years-old | > |
Male and Female
1) Patients aged 20 and more than 20 years old
2) Diagnosed with RA according to the American College of Rheumatology (ACR) 1987 or ACR/ European League Against Rheumatism (EULAR) 2010 criteria
3) Patients who correspond with eligible patients for treatments with abatacept according to the JCR guideline 2010, or who have SDAI>=11 or DAS28-ESR>=3.2 regarded as eligible patients by the attending physicians
4) Diagnosed with SS according to the Japanese Ministry of Health criteria for the diagnosis of SS 1999 and AECG criteria for SS 2002
5) Patients with subjective sicca symptoms
6) Patients who give a written informed consent to this study
1) Patients with contraindication for abatacept
2) Aged 75 and more than 75 years old
3) Patients with leukopenia (leukocyte count<=3000) and positive for B-D Glucan
4) Patients who are pregnant, nursing, want to get pregnant
5) Aged less than 20 years old
6) Patients who are treated with palliative therapies for dryness including cevimeline, anetholtritione, and pilocarpine within the last 4 weeks
7) Patients with severe liver or kidney diseases, severe hematological disorders
8) Patients with negative for both anti-SS-A and SS-B antibody and positive for anti-centromere antibody
9) Patients who are considered not suitable for this study by the attending physicians
81
1st name | Isao |
Middle name | |
Last name | Matsumoto |
Department of Internal Medicine, Faculty of Medicine, University of Tsukuba
Division of Rheumatology
305-8575
1-1-1 Tennodai, Tsukuba-city, Ibaraki 305-8575, Japan
029-853-3186
ismatsu@md.tsukuba.ac.jp
1st name | Hiroto |
Middle name | |
Last name | Tsuboi |
Department of Internal Medicine, Faculty of Medicine, University of Tsukuba
Division of Rheumatology
305-8575
1-1-1 Tennodai, Tsukuba-city, Ibaraki 305-8575, Japan
029-853-3186
Hiroto-Tsuboi@md.tsukuba.ac.jp
Department of Internal Medicine, Faculty of Medicine, University of Tsukuba
Bristol-Myers Squibb (BMS)
Profit organization
USA
1) University of Occupational and Environmental Health
2) Nagasaki University
3) Hokkaido University
4) Kanazawa University
5) Keio University
6) Nihon University Itabashi Hospital
7) Juntendo University Hospital
8) Saitama Medical University
9) Kyoto University
10) National Hospital Organization Osaka Minami Medical Center
11) Hyogo College of Medicine
12) Kurashiki Medical Center
The local ethics committees of University of Tsukuba Hospital
2-1-1 Amakubo, Tsukuba-city, Ibaraki 305-8576, Japan
029-853-3914
chiken@un.tsukuba.ac.jp
NO
1)筑波大学(茨城県)
2)産業医科大学(福岡県)
3)長崎大学病院(長崎県)
4)北海道大学病院(北海道)
5)金沢大学附属病院(石川県)
6)慶應義塾大学病院(東京都)
7)日本大学医学部附属板橋病院(東京都)
8)順天堂大学医学部附属順天堂医院(東京都)
9)埼玉医科大学(埼玉県)
10)京都大学附属病院(京都府)
11)国立病院機構大阪南医療センター(大阪府)
12)兵庫医科大学病院(兵庫県)
13)倉敷成人病クリニック(岡山県)
1) University of Tsukuba (Ibaraki)
2) University of Occupational and Environmental Health (Fukuoka)
3) Nagasaki University (Nagasaki)
4) Hokkaido University (Hokkaido)
5) Kanazawa University (Ishikawa)
6) Keio University (Tokyo)
7) Nihon University Itabashi Hospital (Tokyo)
8) Juntendo University Hospital (Tokyo)
9) Saitama Medical University (Saitama)
10) Kyoto University (Kyoto)
11) National Hospital Organization Osaka Minami Medical Center (Osaka)
12) Hyogo College of Medicine (Hyogo)
13) Kurashiki Medical Center (Okayama)
2015 | Year | 01 | Month | 20 | Day |
Published
68
Delay expected |
Under preparation
2022 | Year | 02 | Month | 04 | Day |
Main results already published
2014 | Year | 08 | Month | 04 | Day |
2014 | Year | 08 | Month | 04 | Day |
2014 | Year | 08 | Month | 04 | Day |
2020 | Year | 12 | Month | 31 | Day |
2021 | Year | 12 | Month | 31 | Day |
2021 | Year | 12 | Month | 31 | Day |
2021 | Year | 12 | Month | 31 | Day |
1) The percentage of patients who achieved clinical remission by SDAI at 52 weeks
2) CRP, ESR, RF
3) Saxon's test
4) MRI of parotid glands
5) anti-SS-A/SS-B antibody, IgG
6) patients'VAS
7) Joint X-P
8) Joint MRI
9) Joint ultrasonography
10) ESSDAI
11) ESSPRI
2015 | Year | 01 | Month | 20 | Day |
2022 | Year | 07 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018879
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