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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001200
Receipt No. 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

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Basic information
Public title Prospective study of pulmonary infections in patients with rheumatic diseases undergoing immunosuppressive therapy
Acronym Pulmonary infection and immunosuppressive therapy in rheumatic diseases
Scientific Title Prospective study of pulmonary infections in patients with rheumatic diseases undergoing immunosuppressive therapy
Scientific Title:Acronym Pulmonary infection and immunosuppressive therapy in rheumatic diseases
Region
Japan

Condition
Condition 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
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify predictive factors of pulmonary infections in patients with rheumatic diseases undergoing immunosuppressive therapy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Predictive factors of pulmonary infections
Key secondary outcomes 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

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Miyasaka
Organization Tokyo Medical and Dental University
Division name Department of Medicine and Rheumatology
Zip code
Address 1-5-45 Yushima,Bunkyo-ku,Tokyo 113-8519,Japan
TEL 03-5803-5201
Email miya.rheu@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayoshi Harigai
Organization Tokyo Medical and Dental University
Division name Department of Pharmacovigilance Medicine and Rheumatology
Zip code
Address 1-5-45 Yushima,Bunkyo-ku,Tokyo 113-8519,Japan
TEL 03-5803-4677
Homepage URL
Email mharigai.mpha@tmd.ac.jp

Sponsor
Institute Department of Medicine and Rheumatology, Tokyo Medical and Dental University Graduate School
Institute
Department

Funding Source
Organization Research group for reassessment and new development of diagnosis and treatment for life-limiting pulmonary comorbidities in patients with rheumatic diseases
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2009 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
None
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 06 Month 09 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2011 Year 06 Month 01 Day
Date of closure to data entry
2011 Year 07 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2012 Year 03 Month 01 Day

Other
Other related information 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.

Management information
Registered date
2008 Year 06 Month 19 Day
Last modified on
2014 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001464

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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