UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001785 |
|---|---|
| Receipt number | R000002151 |
| Scientific Title | Observational cohort study on risk factors of relapse during remission maintenance therapy in patients with microscopic polyangiitis |
| Date of disclosure of the study information | 2009/03/31 |
| Last modified on | 2011/03/19 16:15:12 |
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Basic information
Public title
Observational cohort study on risk factors of relapse during remission maintenance therapy in patients with microscopic polyangiitis
Acronym
Observational cohort study on risk factors of relapse during remission maintenance therapy in patients with microscopic polyangiitis
Scientific Title
Observational cohort study on risk factors of relapse during remission maintenance therapy in patients with microscopic polyangiitis
Scientific Title:Acronym
Observational cohort study on risk factors of relapse during remission maintenance therapy in patients with microscopic polyangiitis
Region
| Japan |
Condition
Condition
Microscopic polyangiitis
Classification by specialty
| Medicine in general | Pneumology | Nephrology |
| Clinical immunology | Dermatology | Oto-rhino-laryngology |
| Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify risk factors of relapse during remission maintenance therapy in patients with MPO-ANCA-positive microscopic polyangiitis.
Basic objectives2
Others
Basic objectives -Others
Relapse rate
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to relapse
Key secondary outcomes
Risk factors of relapse
Change in vasculitis damage index
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with newly diagnosed microscopic polyangiitis between Jan.1, 2005 and Dec.31, 2006 and under the remission by initial remission induction therapy
Key exclusion criteria
Patients under 20 years old
Malignancy
Replicating hepatitis B and C
History of treatment with steroid and/or immunosuppressive drugs by initial therapy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Makino |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
The Department of Medicine and Clinical Science
Zip code
Address
2-5-1 Shikata-cho, Okayama-city, Okayama, 700-8558, Japan
TEL
086-235-7235
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Research Committe of Intractable Vasculitis Syndrome of the Ministry of Health, Labor and Welfare of
Division name
Secretariat
Zip code
Address
2-5-1 Shikata-cho, Okayama-city, Okayama, 700-8558, Japan
TEL
086-235-7235
Homepage URL
vas-mhlw@md.okayama-u.ac.jp
Sponsor or person
Institute
Research Committe of Intractable Vasculitis Syndrome of the Ministry of Health, Labor and Welfare of Japan
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
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
| 2009 | Year | 03 | Month | 31 | 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
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
| 2009 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
To clarify the rate of relapse and its risk factors during remission maintenance therapy in patients with MPO-ANCA-positive microscopic polyangiitis.
Management information
Registered date
| 2009 | Year | 03 | Month | 19 | Day |
Last modified on
| 2011 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002151
