An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With RA and AS
Recruiting
- Conditions
- Ankylosing SpondylitisRheumatoid Arthritis
- Registration Number
- NCT05835518
- Lead Sponsor
- Yuhan Corporation
- Brief Summary
This Study is to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis, An Observational, Prospective Study
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
- Men and women between the ages of over 19 and under 75 at the time of consent
- Patients diagnosed with RA or AS at least 3 months prior to the study registration
- Patients who are scheduled to be prescribed Adalloce according to the doctor's opinions
- Patients who have never received Adalloce
- Patients who voluntarily gave their written consent after being sufficiently explained about the purpose and contents of this study
Exclusion Criteria
- Patients with hypersensitivity to this drug or its components
- Patients with active tuberculosis or other severe infection such as sepsis or opportunistic infection
- Patients with moderate to severe heart failure (NYHA class III/IV)
- Patients who are judged to be inappropriate for Adalloce administration according to the approved conditions
- Patients who are not suitable for participation in this study according to the judgment of the investigator
- Patients participating in other drug clinical trials (Adalloce PMS participants cannot participate in this study)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in quality of life (EQ-5D-5L) scores at 52 weeks from baseline in patients with RA and AS 52weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of