Prospective study of pulmonary infections in patients with rheumatic diseases undergoing immunosuppressive therapy

Prospective study of pulmonary infections in patients with rheumatic diseases undergoing immunosuppressive therapy - Pulmonary infection and immunosuppressive therapy in rheumatic diseases

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000001200

Enrollment

1000

Registered

2009-09-01

Start date

2008-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheumatoid arthritis (including rheumatoid arthritis with vasculitis), systemic lupus erythematosus, polymyositis, dermatomyositis, systemic sclerosis, mixed connective tissue disease, vasculitis syndrome, primary Sjogren&#39

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

Measure	Time frame
Predictive factors of pulmonary infections	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactMasayoshi Harigai

Tokyo Medical and Dental University Department of Pharmacovigilance Medicine and Rheumatology

mharigai.mpha@tmd.ac.jp03-5803-4677

Outcome results