Safety of Biologics in Clinical Use in Japanese Patients with Rheumatoid Arthritis in Long-Term (SECURE)
Not Applicable
- Conditions
- Rheumatoid Arthritis
- Registration Number
- JPRN-UMIN000001203
- Lead Sponsor
- Japan College of Rheumatology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 15000
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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