UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002340 |
|---|---|
| Receipt number | R000002863 |
| Scientific Title | Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET) |
| Date of disclosure of the study information | 2009/08/20 |
| Last modified on | 2011/10/25 18:13:18 |
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Basic information
Public title
Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET)
Acronym
cHAMLET
Scientific Title
Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET)
Scientific Title:Acronym
cHAMLET
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effectiveness between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to low-dose infliximab (3mg/Kg) therapy,
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
DAS28, EULAR responsiveness
Key secondary outcomes
mHAQ, The number and dosages of concomitant medication
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with higher dosages of infliximab (3-10 mg/Kg)
Every 2 months
Follow-up to 54 weeks
Interventions/Control_2
Treatment with one of other biologics (etanercept, adalimumab, tocilizumab) in standard protocol
Follow-up to 54 weeks
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 whose DAS28-ESR are over 3.2 (DAS28-CRP>2.7) after low-dose infliximab (3mg/Kg) therapy at least 5 times
Key exclusion criteria
Patients whose DAS28-ESR are below 3.2 (DAS28-CRP>2.7) after low-dose infliximab (3mg/Kg) therapy at least 5 times
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Koike |
Organization
Osaka City University Medical School
Division name
Rheumatosurgery
Zip code
Address
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL
06-6645-3984
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Koike |
Organization
Osaka City University Medical School
Division name
Rheumatosurgery
Zip code
Address
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL
06-6645-3984
Homepage URL
tatsuya@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Rheumatosurgery, Osaka City University Medical School
Institute
Department
Personal name
Funding Source
Organization
Department of Rheumatosurgery, Osaka City University Medical School
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
大阪市立大学医学部付属病院（大阪府）、北出病院（和歌山県）、白浜はまゆう病院（和歌山県）、中通総合病院（秋田県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 08 | Month | 20 | 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 | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 10 | 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
Management information
Registered date
| 2009 | Year | 08 | Month | 17 | Day |
Last modified on
| 2011 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002863
