UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002421 |
|---|---|
| Receipt number | R000002954 |
| Scientific Title | Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis |
| Date of disclosure of the study information | 2009/09/04 |
| Last modified on | 2013/09/03 11:42:14 |
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Basic information
Public title
Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis
Acronym
Comparative study of tocilizumab therapy versus conventional therapy for the treatment of rheumatoid arthritis complicating AA amyloidosis
Scientific Title
Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis
Scientific Title:Acronym
Comparative study of tocilizumab therapy versus conventional therapy for the treatment of rheumatoid arthritis complicating AA amyloidosis
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of drug treatment, including biologics, on the suppression of AA amyloidosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of the amyloid deposition in the gastric biopsy specimen
Key secondary outcomes
Change of renal function
Serum creatinine, urinary protein, urinary creatinine, estimated creatinine clearance, cystatin C
Change of serum SAA
Change of diarrhea frequency
Change of DAS28-ESR
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
tocilizumab
Interventions/Control_2
Conventional DMARDs and immune suppressive drugs and biologics except for tocilizumab
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
1. Diagnosis of rheumatoid arthritis using the American College of Rheumatology classification criteria (1987)
2. Confirmation of the amyloid deposition by the tissue biopsy or diagnosis of "rheumatoid arthritis complicating AA amylidosis" in own institution
3. Patients who have the observational periods for about six months before starting the study
4. Patients must sign the informed consent
Key exclusion criteria
1. Pregnancy, lactation or planning pregnancy
2. Complicating severe infection
3. History of hypersensitivity to the treatment drug
4. Patients who are judged to be inappropriate by investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Yoshizaki |
Organization
Osaka University
Division name
Immuno-Medical Science Division of Applied Chemistry, Graduate School of Engineering
Zip code
Address
Office for University-Industry Collaboration, Osaka Univ. Bid. Incubation A-407, 2-1, Yamadaoka, Suita City, Osaka
TEL
06-6879-4738
kyoshi@chem.eng.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Yoshizaki |
Organization
Osaka University
Division name
Immuno-Medical Science Division of Applied Chemistry, Graduate School of Engineering
Zip code
Address
Office for University-Industry Collaboration, Osaka Univ. Bid. Incubation A-407, 2-1, Yamadaoka,
TEL
06-6879-4738
Homepage URL
kyoshi@chem.eng.osaka-u.ac.jp
Sponsor or person
Institute
AA amyloidosis clinical research conference
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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 | 09 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2008 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 01 | Day |
Last modified on
| 2013 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002954
