UMIN ID: UMIN000001200
Registered date:01/09/2009
Prospective study of pulmonary infections in patients with rheumatic diseases undergoing immunosuppressive therapy
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | 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 |
| Date of first enrollment | 2008/06/01 |
| Target sample size | 1000 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Predictive factors of pulmonary infections |
|---|---|
| Secondary Outcome | 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 |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 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. |
Related Information
| Primary Sponsor | Department of Medicine and Rheumatology, Tokyo Medical and Dental University Graduate School |
|---|---|
| Secondary Sponsor | None |
| Source(s) of Monetary Support | Research group for reassessment and new development of diagnosis and treatment for life-limiting pulmonary comorbidities in patients with rheumatic diseases,None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Masayoshi Harigai |
| Address | 1-5-45 Yushima,Bunkyo-ku,Tokyo 113-8519,Japan Japan |
| Telephone | 03-5803-4677 |
| mharigai.mpha@tmd.ac.jp | |
| Affiliation | Tokyo Medical and Dental University Department of Pharmacovigilance Medicine and Rheumatology |
| scientific contact | |
| Name | Nobuyuki Miyasaka |
| Address | 1-5-45 Yushima,Bunkyo-ku,Tokyo 113-8519,Japan Japan |
| Telephone | 03-5803-5201 |
| miya.rheu@tmd.ac.jp | |
| Affiliation | Tokyo Medical and Dental University Department of Medicine and Rheumatology |