UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001203 |
|---|---|
| Receipt number | R000001467 |
| Scientific Title | Safety of Biologics in Clinical Use in Japanese Patients with Rheumatoid Arthritis in Long-Term (SECURE) |
| Date of disclosure of the study information | 2008/09/01 |
| Last modified on | 2008/06/20 12:13:13 |
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Basic information
Public title
Safety of Biologics in Clinical Use in Japanese Patients with Rheumatoid Arthritis in Long-Term (SECURE)
Acronym
Long-term safety of biologics in Japanese RA patients
Scientific Title
Safety of Biologics in Clinical Use in Japanese Patients with Rheumatoid Arthritis in Long-Term (SECURE)
Scientific Title:Acronym
Long-term safety of biologics in Japanese RA patients
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japan, biological disease modifying anti-rheumatic drugs (biological DMARDs) including infliximab, etanercept, tocilizumab and adalimumab have been approved for rheumatoid arthritis (RA) and more than 40,000 patients with RA have received these drugs. All these drugs have been subjected to strict post-marketing surveillances (PMS) by Japanese Ministry of Health, Labor and Welfare; 5,000 patients with RA receiving infliximab and about 14,000 patients receiving etanercept were enrolled in each PMS program. In this study, Long-term safety of biological DMARDs in Japanese patients with RA, mainly in those who was or going to be enrolled in PMS programs, will be investigated, focusing on incidence of malignancy, especially malignant lymphoma, and life prognosis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. accumulated incidence of malignant lymphoma in patients with RA who have received biological DMARDs
2. pathological classification and percentages of malignant lymphoma in patients with RA who have received biological DMARDs
Key secondary outcomes
1. Five-year survival rate of patients with RA who have received biological DMARDs
2. accumulated incidence of hematological malignancy including malignant lymphoma in patients with RA who have received biological DMARDs
3. accumulated incidence of non-hematological malignancy in patients with RA who have received biological DMARDs
4. classification and percentages of malignancies in patients with RA who have received biological DMARDs
5. percentages of malignancy as causes of death in patients with RA who have received biological DMARDs
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients must meet the following criteria to be eligible for study entry:
1. Age > 20 years
2. Received or are receiving biological DMARDs(infliximab, etanercept, tocilizumab and adalimumab are included as of May 2008, but other biological DMARDs will be included after their approval) in the participating centers of SECURE study.
3. Participating centers should provide enough information about SECURE study to their patients as described below.
a. SECURE study will collect medical information of enrolled patients which can be obtained from daily practice and provide enough information about the study to the targeted patients population. According to the ethical guideline for epidemiological study in Japan, written informed consent from each patient will not be required. Included in enough information are putting up posters and distribute leaflets about the study in each center, opening a homepage about the study for patients and their families and inserting notification about the study in a journal of patients association for RA. Patients can refuse to join the study at any time through their doctors or by contacting with the headquarters of the study.
b. Written informed consent will be required if IRB of each center ordes to obtain it.
c. Each center is encouraged to enroll patients who received biological DMARDs but already discontinued it and provide data of these patients in their medical recorders. This is particularly important because those who were lost to is particularly important because those who were lost to be followed-up may have higher probability of being suffered from malignancies and moved to another hospital for treatments.
Key exclusion criteria
A patient who has any of the following will be excluded from the study.
1. When a patient refuses to join the study or withdraw his or her consent.
2. When a doctor judged a patient not appropriate to join the study based on medical or social reasons.
Target sample size
15000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Koike |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Medicine II
Zip code
Address
N15 W7, Kita-ku, Sapporo
TEL
011-716-1161(5913)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayoshi Harigai |
Organization
Tokyo Medical and Dental university
Division name
Depertment of Pharmacovigilance, Depertment of medicine and Rheumatology
Zip code
Address
5-45, Yushima 1-chome, Bunkyo-ku, Tokyo
TEL
03-5803-4677
Homepage URL
secure.phv@tmd.ac.jp
Sponsor or person
Institute
Japan College of Rheumatology
Institute
Department
Personal name
Funding Source
Organization
Japan College of Rheumatology
Depertment of Pharmacovigilance, Tokyo Medical and Dental university
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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
| 2008 | Year | 09 | Month | 01 | 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
Date of protocol fixation
| 2008 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 01 | Day |
Other
Other related information
Association of background of patients(age, sex, biologics, etc) and malignancy or survival rate will beevaluated.
Management information
Registered date
| 2008 | Year | 06 | Month | 20 | Day |
Last modified on
| 2008 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001467
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