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Recruitment status Completed
Unique ID issued by UMIN UMIN000011789
Receipt No. R000013741
Official scientific title of the study 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

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Basic information
Official scientific title of the study Usefulness of intravenous abatacept at an increased dose in rheumatoid arthritis patients with a poor prognosis
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Daihei Kida
Organization National Health Organization Nagoya Medical Center
Division name Orthopedic Surgery and Rheumatology
Address 4-1-1 Sannomaru, Naka-ku, Nagoya, 460-0001 Aichi, JAPAN
TEL 052-951-1111
Email kidad@nnh.hosp.go.jp

Public contact
Name of contact person Daihei Kida
Organization National Health Organization Nagoya Medical Center
Division name Orthopedic Surgery and Rheumatology
Address 4-1-1 Sannomaru, Naka-ku, Nagoya, 460-0001 Aichi, JAPAN
TEL 052-951-1111
Homepage URL http://www.nnh.go.jp/
Email kidad@nnh.hosp.go.jp

Sponsor
Institute National Health Organization Nagoya Medical Center
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 09 Month 20 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013741


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