UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011789 |
|---|---|
| Receipt number | R000013741 |
| Scientific Title | Usefulness of intravenous abatacept at an increased dose in rheumatoid arthritis patients with a poor prognosis |
| Date of disclosure of the study information | 2013/09/20 |
| Last modified on | 2013/09/18 10:02:40 |
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Basic information
Public title
Usefulness of intravenous abatacept at an increased dose in rheumatoid arthritis patients with a poor prognosis
Acronym
Intravenous abatacept at an increased dose in RA patients
Scientific Title
Usefulness of intravenous abatacept at an increased dose in rheumatoid arthritis patients with a poor prognosis
Scientific Title:Acronym
Intravenous abatacept at an increased dose in RA patients
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of increased dose of abatacept in patients with moderate rheumatoid arthritis previously treated with abatacept.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The effect of dose increase of abatacept:
1. Number of painful joints
2. Number of swollen joints
3. VAS (patient's global assessment)
4. VAS (physician's global assessment)
5. Erythrocyte sedimentation rate
6. CRP
7. DAS28-ESR
8. DAS28-CRP
9. mHAQ
10. MMP-3
Key secondary outcomes
1. DAS28-ESR and DAS28-CRP according to the dose per kg body weight
2. EULAR Response
3. ACR20
4. Adverse events
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of increased dose of abatacept to patients with rheumatoid arthritis previously treated with abatacept.
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
1. Patients with rheumatoid arthritis (meeting the ACR criteria in 2010)
2. Patients who had a response to intravenous treatment with ABT at a dose of 2 vials within 3 months before dose increase and had less than 4% decrease in DAS28-ESR over 4 weeks before dose increase
3. Patients who gave oral presentation of informed consent
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daihei Kida |
Organization
National Health Organization Nagoya Medical Center
Division name
Orthopedic Surgery and Rheumatology
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya, 460-0001 Aichi, JAPAN
TEL
052-951-1111
kidad@nnh.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daihei Kida |
Organization
National Health Organization Nagoya Medical Center
Division name
Orthopedic Surgery and Rheumatology
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya, 460-0001 Aichi, JAPAN
TEL
052-951-1111
Homepage URL
http://www.nnh.go.jp/
kidad@nnh.hosp.go.jp
Sponsor or person
Institute
National Health Organization Nagoya Medical Center
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
National Health Organization Nagoya Medical Center
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | 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
| 2010 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 18 | Day |
Last modified on
| 2013 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013741
