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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021004
Receipt No. R000019658
Scientific Title Effectiveness and safety of tocilizumab therapy for rheumatoid artritis patients
Date of disclosure of the study information 2016/02/13
Last modified on 2018/10/17

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Basic information
Public title Effectiveness and safety of tocilizumab therapy for rheumatoid artritis patients
Acronym Effectiveness of tocilizumab therapy for rheumatoid artjritis patients complicated with interstitial pneumonia.
Scientific Title Effectiveness and safety of tocilizumab therapy for rheumatoid artritis patients
Scientific Title:Acronym Effectiveness of tocilizumab therapy for rheumatoid artjritis patients complicated with interstitial pneumonia.
Region
Japan

Condition
Condition Rheumatoid arthritis complicated with interstitial pneumonia
Classification by specialty
Medicine in general Pneumology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the therapeutic effect of tocilizumab for rheumatoid arthritis patients complicated with interstitial pneumonia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)Improvement of disease activity of rheumatoid arthritis

2)Change of severerity of interstitial pneumonia (stage, forced volume capacity)
Key secondary outcomes

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 Rheumatoid arthrit patients with high disease activity and chronic fibrosing interstitial lung disease
Key exclusion criteria Patients who does not agree to tocilizumab therapy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Mori
Organization NHO Kumamoto Saishunsou National Hospital
Division name Rheumatology
Zip code
Address 2659 Suya, Kohshi, Kumamoto Japan
TEL 81-96-242-1000
Email moris@saisyunsou1.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunichi Tsutumiuchi
Organization 2659 Suya, Kohshi, Kumamoto Japan
Division name Secretariat
Zip code
Address 2659 Suya, Kohshi, Kumamoto Japan
TEL 81-96-242-1000
Homepage URL
Email 8211sy01@hosp.go.jp

Sponsor
Institute NHO Kumamoto Saishunsou National Hospital
Institute
Department

Funding Source
Organization NHO Kumamoto Saishunsou National Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2016 Year 02 Month 13 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
Among 19 patiets, nine were diagnosed with definite usual interstitia pneumonia (UIP) pattern, eight with possible UIP, one with UIP/nonspecific interstitial pneumonia (NSIP), and one with combined pulmonary fibrosis and emphysema (CPFE).Median CDAI values were significantly imroved during the treatment . ALL patients with possible UIP, CPFE, and UIP/NSIP patterns completed the 96-week treatment and their pulmonary conditions remained stablilized. In contrast, among the patients with UIP pateern, two experienced a worsning of ILD and five withdrew from this study due to the reasons not directly associated with ILD exacerbation.
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
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Considering that the current goal of treatment of progressive fibrosing ILD is stabilization or slow progression of the disease. tocilizumab may represent therapeutic option for RA
patients with this type of ILD.

Management information
Registered date
2016 Year 02 Month 13 Day
Last modified on
2018 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019658

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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