Actively Recruiting
An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis
Led by Yuhan Corporation · Updated on 2023-05-09
1000
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Adalloce in adult patients diagnosed with Rheumatoid Arthritis (RA) or Ankylosing Spondylitis (AS). This observational, prospective study aims to monitor patients who are newly prescribed Adalloce and have not previously received this medication. The study is sponsored by Yuhan Corporation and focuses on understanding how this treatment affects patients' quality of life. The study includes patients scheduled to receive Adalloce based on their doctor's recommendation. Participants will be observed over a period of 52 weeks to track changes in their health and well-being. There are no placebo or comparison groups, as this is an observational study monitoring the real-world use of Adalloce. During the study, participants will undergo regular assessments to measure changes in their quality of life using the EQ-5D-5L questionnaire. Researchers will collect data on how patients respond to the medication over time, including any side effects or safety concerns. The total duration of participation is one year, with evaluations conducted from the beginning through 52 weeks.
CONDITIONS
Brief Title
An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With RA and AS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women between the ages of over 19 and under 75 at the time of consent
- Patients diagnosed with Rheumatoid Arthritis or Ankylosing Spondylitis at least 3 months before study registration
- Patients scheduled to be prescribed Adalloce according to a doctor's recommendation
- Patients who have never received Adalloce before
- Patients who voluntarily provide written consent after understanding the study purpose and details
You will not qualify if you...
- Patients with hypersensitivity to Adalloce or its components
- Patients with active tuberculosis or other severe infections such as sepsis or opportunistic infections
- Patients with moderate to severe heart failure classified as NYHA class III or IV
- Patients deemed inappropriate for Adalloce use based on approved conditions
- Patients judged unsuitable for study participation by the investigator
- Patients currently participating in other drug clinical trials (Adalloce PMS participants are excluded)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants are observed to assess the efficacy and safety of Adalloce over time.
Regular visits over 52 weeks
Trial Site Locations
Total: 1 location
1
Daegu Catholic University Medical Center
Daegu, South Korea
Actively Recruiting
Research Team
H
Hee Suh
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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