Rheumatoid Arthritis complicated with Sjogren'
Conditions
Interventions
None listed
Sponsors
Department of Internal Medicine, Faculty of Medicine, University of Tsukuba
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
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients who achieved clinical remission by SDAI at 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHiroto Tsuboi
Department of Internal Medicine, Faculty of Medicine, University of Tsukuba Division of Rheumatology
Outcome results
None listed