UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013440 |
|---|---|
| Receipt number | R000015693 |
| Scientific Title | To evaluate the efficacy and safety of subcutaneous and intravenous abatacept. |
| Date of disclosure of the study information | 2014/03/18 |
| Last modified on | 2018/09/08 14:30:16 |
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Basic information
Public title
To evaluate the efficacy and safety of subcutaneous and intravenous abatacept.
Acronym
Subcutaneous and abatacept versus intravenous abatacept.
Scientific Title
To evaluate the efficacy and safety of subcutaneous and intravenous abatacept.
Scientific Title:Acronym
Subcutaneous and abatacept versus intravenous abatacept.
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to compare the efficacy and safety of subcutaneous and intravenous abatacept and was to assess whether remission would be sustained with extension of subcutaneous abatacept in patients with rheumatoid arthritis after clinical remission.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of patients completed 36 weeks with SC abatacept 2 weeks dose intervals.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SC abatacept
Interventions/Control_2
IV abatacept
Interventions/Control_3
Extension of SC abatacept
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who met the ACR 1987 revised criteria for the classification of RA.
2. Patients diagnosed as moderate disease activity (2.3<DAS28-CRP<4.1).
3. Anti-cyclic citrullinated peptide antibody >100 U/mL or rheumatoid factor >60 IU/mL.
Key exclusion criteria
Patients were excluded if they were previously treated with biological DMARDs.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuzo Yoshida |
Organization
Osaka Medical College
Division name
Department of Internal Medicine (I)
Zip code
Address
Daigaku-Machi 2-7, Takatsuki, Osaka 569-8686, Japan
TEL
+81-72-683-1221
in1307@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuzo Yoshida |
Organization
Osaka Medical College
Division name
Department of Internal Medicine (I)
Zip code
Address
Daigaku-Machi 2-7, Takatsuki, Osaka 569-8686, Japan
TEL
+81-72-683-1221
Homepage URL
in1307@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
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
| 2014 | Year | 03 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | 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
Management information
Registered date
| 2014 | Year | 03 | Month | 17 | Day |
Last modified on
| 2018 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015693
