UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021004 |
|---|---|
| Receipt number | 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 15:43:23 |
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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
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
8211sy01@hosp.go.jp
Sponsor or person
Institute
NHO Kumamoto Saishunsou National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019658
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
