NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000001203

Registered date:01/09/2008

Safety of Biologics in Clinical Use in Japanese Patients with Rheumatoid Arthritis in Long-Term (SECURE)

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedRheumatoid Arthritis
Date of first enrollment2008/09/01
Target sample size15000
Countries of recruitmentJapan
Study typeObservational
Intervention(s)

Outcome(s)

Primary Outcome1. 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
Secondary Outcome1. 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

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteriaPatients 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.
Exclude criteriaA 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.

Related Information

Contact

public contact
Name Masayoshi Harigai
Address 5-45, Yushima 1-chome, Bunkyo-ku, Tokyo Japan
Telephone 03-5803-4677
E-mail secure.phv@tmd.ac.jp
Affiliation Tokyo Medical and Dental university Depertment of Pharmacovigilance, Depertment of medicine and Rheumatology
scientific contact
Name Takao Koike
Address N15 W7, Kita-ku, Sapporo Japan
Telephone 011-716-1161(5913)
E-mail
Affiliation Hokkaido University Graduate School of Medicine Department of Medicine II