Actemra, Long-Term Special Drug Use Surveillance in Takayasu arteritis and Giant cell arteritis patients
Not Applicable
- Conditions
- Takayasu arteritis, Giant cell arteritis
- Registration Number
- JPRN-UMIN000029056
- Lead Sponsor
- Chugai Pharmaceutical Co. Ltd.
- Brief Summary
GCA Of the 117 patients 38.5% reported adverse events The most common adverse events of special interest were neutropaenia and leukopaenia 7.7% followed by serious infection 6.0% The relapse-free proportion was 85.0%; relapse after remission 6.0% and no remission 9.0% At the last observation, 94.2% of relapse-free patients received a concomitant glucocorticoid dose of under 10 mg per day Fatigue headache neck pain and absence of LVLs were positively associated with the relapse etc
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 132
Inclusion Criteria
Not provided
Exclusion Criteria
No criteria
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events and adverse drug reactions Daily fluctuation of corticosteroid Changes in clinical features of TAK/GCA Rate of relapse, etc.
- Secondary Outcome Measures
Name Time Method