UMIN-CTR Clinical Trial

Basic information
Public title	Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome Endocrinopathy (ROSE II Trial)
Acronym	Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome syndrome Endocrinopathy (ROSE II Trial)
Scientific Title	Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome Endocrinopathy (ROSE II Trial)
Scientific Title:Acronym	Rheumatoid Arthritis with Orencia Trial Toward Sjogren's syndrome syndrome Endocrinopathy (ROSE II Trial)
Region	Japan

Condition
Condition	Rheumatoid Arthritis complicated with Sjogren's syndrome
Classification by specialty	Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	The percentage of patients who achieved clinical remission by SDAI at 52 weeks
Key secondary outcomes	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

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) 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
Key exclusion criteria	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
Target sample size	81

Research contact person
Name of lead principal investigator	1st name Isao Middle name Last name Matsumoto
Organization	Department of Internal Medicine, Faculty of Medicine, University of Tsukuba
Division name	Division of Rheumatology
Zip code	305-8575
Address	1-1-1 Tennodai, Tsukuba-city, Ibaraki 305-8575, Japan
TEL	029-853-3186
Email	ismatsu@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Hiroto Middle name Last name Tsuboi
Organization	Department of Internal Medicine, Faculty of Medicine, University of Tsukuba
Division name	Division of Rheumatology
Zip code	305-8575
Address	1-1-1 Tennodai, Tsukuba-city, Ibaraki 305-8575, Japan
TEL	029-853-3186
Homepage URL
Email	Hiroto-Tsuboi@md.tsukuba.ac.jp

Sponsor
Institute	Department of Internal Medicine, Faculty of Medicine, University of Tsukuba
Institute
Department

Funding Source
Organization	Bristol-Myers Squibb (BMS)
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	USA

Other related organizations
Co-sponsor	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
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The local ethics committees of University of Tsukuba Hospital
Address	2-1-1 Amakubo, Tsukuba-city, Ibaraki 305-8576, Japan
Tel	029-853-3914
Email	chiken@un.tsukuba.ac.jp

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

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)

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	68
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Under preparation
Date of the first journal publication of results	2022 Year 02 Month 04 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 08 Month 04 Day
Date of IRB	2014 Year 08 Month 04 Day
Anticipated trial start date	2014 Year 08 Month 04 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 12 Month 31 Day
Date trial data considered complete	2021 Year 12 Month 31 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information	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

Management information
Registered date	2015 Year 01 Month 20 Day
Last modified on	2022 Year 07 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018879