An observational, prospective study to assess the efficacy and safety of Adalloce in patients with Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS)
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0009141
- Lead Sponsor
- Yuhan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1000
1. Men and women between the ages of over 19 and under 75 at the time of consent
2. Patients diagnosed with RA or AS at least 3 months prior to the study registration
3. Patients who are scheduled to be prescribed Adalloce according to the doctor's opinions
4. Patients who have never received Adalloce
5. Patients who voluntarily gave their written consent after being sufficiently explained about the purpose and contents of this study
1. Patients with hypersensitivity to this drug or its components
2. Patients with active tuberculosis or other severe infection such as sepsis or opportunistic infection
3. Patients with moderate to severe heart failure (NYHA class III/IV)
4. Patients who are judged to be inappropriate for Adalloce administration according to the approved conditions
5. Patients who are not suitable for participation in this study according to the judgment of the investigator
6. Patients participating in other drug clinical trials (Adalloce PMS participants cannot participate in this study)
Study & Design
- Study Type
- Observational Study
- 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
- Secondary Outcome Measures
Name Time Method Disease activity, clinical remission rate, and response rate by time after initiation of adalloce treatment;QoL in patients treated with Adalloce;Adalloce retention rate and factors affecting retention rate;Evaluation of anti-drug antibody formation;Self-injection site evaluation