Unique ID issued by UMIN | UMIN000001200 |
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Receipt number | R000001464 |
Scientific Title | Prospective study of pulmonary infections in patients with rheumatic diseases undergoing immunosuppressive therapy |
Date of disclosure of the study information | 2009/09/01 |
Last modified on | 2014/06/24 14:39:05 |
Prospective study of pulmonary infections in patients with rheumatic diseases undergoing immunosuppressive therapy
Pulmonary infection and immunosuppressive therapy in rheumatic diseases
Prospective study of pulmonary infections in patients with rheumatic diseases undergoing immunosuppressive therapy
Pulmonary infection and immunosuppressive therapy in rheumatic diseases
Japan |
rheumatoid arthritis (including rheumatoid arthritis with vasculitis), systemic lupus erythematosus, polymyositis, dermatomyositis, systemic sclerosis, mixed connective tissue disease, vasculitis syndrome, primary Sjogren's syndrome, Bechet disease, adult onset Still's disease
Clinical immunology |
Others
NO
To identify predictive factors of pulmonary infections in patients with rheumatic diseases undergoing immunosuppressive therapy.
Safety
Exploratory
Pragmatic
Not applicable
Predictive factors of pulmonary infections
Association of pulmonary infection with survival rate
Implementation and effectiveness of prophylaxis for Pneumocystis pneumonia
Implementation and effectiveness of prophylaxis for M. tuberculosis
Implementation and effectiveness of vaccination for Streptococcus pneumoniae
Observational
Not applicable |
Not applicable |
Male and Female
Patients must meet the following criteria to be eligible for study entry:
1.Have diagnosis of rheumatoid arthritis (including rheumatoid arthritis with vasculitis), systemic lupus erythematosus, polymyositis, dermatomyositis, systemic sclerosis, mixed connective tissue disease, vasculitis syndrome, primary Sjogren's syndrome, Bechet disease, or adult onset Still's disease.
2.Admit to medical centers which participate in this study.
3.Have ability and willingness to provide written informed consent and to comply with the requirement of the protocol.
4.Patients must
Start new treatment with corticosteroid or increase dosages, or
Start new treatment with immunosuppressant (azathioprine, methotrexate, cyclophosphamide, tacrolimus, ciclosporin, mizoribine, or leflunomide), switch immunosuppresant or increase dosages,
Start new treatment with biologics (infliximab, etanercept, adalimumab, rituximab or tocilizumab), switch biologics.
1.When patients withdraw consent to join the study.
2.When an attending doctor judges that enrollment of a patient is inappropriate
3.When patients participate in a clinical trial for approval of a drug in Japan.
1000
1st name | |
Middle name | |
Last name | Nobuyuki Miyasaka |
Tokyo Medical and Dental University
Department of Medicine and Rheumatology
1-5-45 Yushima,Bunkyo-ku,Tokyo 113-8519,Japan
03-5803-5201
miya.rheu@tmd.ac.jp
1st name | |
Middle name | |
Last name | Masayoshi Harigai |
Tokyo Medical and Dental University
Department of Pharmacovigilance Medicine and Rheumatology
1-5-45 Yushima,Bunkyo-ku,Tokyo 113-8519,Japan
03-5803-4677
mharigai.mpha@tmd.ac.jp
Department of Medicine and Rheumatology, Tokyo Medical and Dental University Graduate School
Research group for reassessment and new development of diagnosis and treatment for life-limiting pulmonary comorbidities in patients with rheumatic diseases
Japan
None
None
NO
2009 | Year | 09 | Month | 01 | Day |
Unpublished
None
Completed
2008 | Year | 06 | Month | 09 | Day |
2008 | Year | 06 | Month | 01 | Day |
2011 | Year | 06 | Month | 01 | Day |
2011 | Year | 07 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
For the primany endpoint, we will identify predictive factors among baseline data for pulmonary infection using univariable and multi-variable analysis.
For the secondary endpoint, effect of pulmonary infection on short-term (2 years) life prognosis will be analyzed using multi-variable analysis, Kaplan-Meier method and Logrank method.
2008 | Year | 06 | Month | 19 | Day |
2014 | Year | 06 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001464
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