UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020046 |
|---|---|
| Receipt number | R000023151 |
| Scientific Title | A study of the relationship between the HLA-DR beta 1 genotype and therapeutic response of abatacept (ABT) in patients with rheumatoid arthritis (RA) |
| Date of disclosure of the study information | 2015/12/03 |
| Last modified on | 2016/12/20 17:19:59 |
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Basic information
Public title
A study of the relationship between the HLA-DR beta 1 genotype and therapeutic response of abatacept (ABT) in patients with rheumatoid arthritis (RA)
Acronym
A study of the relationship between the HLA-DR beta 1 genotype and therapeutic response of ABT in patients with RA
Scientific Title
A study of the relationship between the HLA-DR beta 1 genotype and therapeutic response of abatacept (ABT) in patients with rheumatoid arthritis (RA)
Scientific Title:Acronym
A study of the relationship between the HLA-DR beta 1 genotype and therapeutic response of ABT in patients with RA
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the efficacy and safety of ABT in patients with rheumatoid arthritis (RA) stratified by the presence or absence of anti-cyclic citrullinated peptide antibody (ACPA) and shared epitope (SE), a common amino acid sequence associated with RA susceptibility, prospectively.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of the patients whose DAS28-ESR score was <2.6 at week 24
Key secondary outcomes
Clinical improvement
1) Rate of the patients whose DAS28-CRP score achieved <2.3 at week 24
2) Clinical remission rate defined by SDAI at week 52
Base
Study type
Interventional
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
ABT should be administered intravenously for all patients at a dose of 250 mg until week 8. Thereafter, it is permitted to continue intravenous infusion or switch to 125 mg/ml solution for subcutaneous injection. Intravenous infusion is performed at the first of the study, week 2 and 4, and subsequently at 4-week intervals.
Subcutaneous administration is performed at a dose of 125 mg after intervenous infusion as a loading dose on the same day. After that it will be administered subcutaneously once a week. A total administration period is 52 weeks.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients whose written informed consent can be obtained and are >=20, =<75 years of age at the time of informed consent acquisition (regardless of sex, hospitalization or outpatient).
2) Patients with a diagnosis of RA according to the 2010 ACR-EULAR classification criteria for
RA and whose duration of disease from diagnosis is >= 3 months and < 10 years before the day of first administration
3) CRP is >= 0.6 mg/dL, or ESR is >= 28 mm/hr and DAS28-ESR score is >= 3.2 before the day of first administration.
4) ACPA-positive patients whose ACPA is >4.5 U/mL and ACPA-negative patients whose ACPA is <= 4.5 U/mL before the day of first administration.
Key exclusion criteria
1) Patients with serious infections including active tuberculosis
2) Patients with a history of hypersensitivity to ABT or any other excipient of ABT
3) Patients with a history of treatment with anti-rheumatic biological agents
4) Patients administered >= 10 mg/day of systemic corticosteroid preparation as prednisolone equivalent within 28 days before registration day
5) Patients with confirmed hepatitis B (except for HBs/HBc antibody-positive and HBs antigen-negative patients) or hepatitis C at the time of resistration
6) Patients with complications of chronic obstructive pulmonary disease
7) Patients with a history of tuberculosis
8) Patients with complications of extra-articular manifestations such as interstitial pneumonitis
9) Patients whose antinuclear antibody is >160-fold
10) Patients with positive for specific autoantibody against connective tissue disease
11) Patients with the following complications: serious renal disease, liver disease, hematologic disease, digestive system disease, diabetes, malignancy (including a history of malignancy) , thyroid disease, autoimmune disease except RA (chronic thyroiditis and Sjogren's syndrome are eliminated), lung disease, cardiovascular disease, neurological disease, eye disease and brain disease
12) Patients who had undergone surgical therapy for RA such as synovectomy, arthroplasty within 6 months (180 days) before first administration
13) Patients who are pregnant, nursing, possibly pregnant or plan to become pregnant during the research period
14) Patients who are drug or alcohol dependence, or those suspected
15) Patients deemed inappropriate to participate in the research by the investigator
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kensuke Oryoji |
Organization
Matsuyama Red Cross Hospital
Division name
Division of rheumatoid arthritis
Zip code
Address
1, Bunkyo-cho, Matsuyama City, Ehime
TEL
089-924-1111
oryoji76@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kensuke Oryoji |
Organization
Matsuyama Red Cross Hospital
Division name
Division of rheumatoid arthritis
Zip code
Address
1, Bunkyo-cho, Matsuyama City, Ehime
TEL
089-924-1111
Homepage URL
oryoji76@yahoo.co.jp
Sponsor or person
Institute
Matsuyama Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD/Bristol-Myers Squibb
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 12 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 07 | 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
| 2015 | Year | 12 | Month | 03 | Day |
Last modified on
| 2016 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023151
