Assessing the effects of Adalloce in patients with rheumatoid arthritis and ankylosing spondylitis
An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis
This study is testing how well Adalloce works and what side effects it might have in people with rheumatoid arthritis or ankylosing spondylitis who are starting this treatment for the first time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 19 Years to 74 Years |
| Sex | All |
| Sponsor | Yuhan Corporation Industry-sponsored |
| Locations | 1 site (Daegu) |
| Trial ID | NCT05835518 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy and safety of Adalloce in patients diagnosed with rheumatoid arthritis (RA) and ankylosing spondylitis (AS). Participants will be men and women aged 19 to 75 who have been diagnosed with RA or AS for at least three months and are scheduled to receive Adalloce for the first time. The study will collect data on the outcomes and side effects experienced by these patients as they begin treatment. The findings will help to better understand how Adalloce works in this patient population.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 19 to 75 with a diagnosis of RA or AS who have never received Adalloce.
Not a fit: Patients with hypersensitivity to Adalloce, severe infections, or significant heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of Adalloce for managing rheumatoid arthritis and ankylosing spondylitis.
How similar studies have performed: While this study focuses on Adalloce specifically, similar observational studies have shown promise in assessing new treatments for RA and AS.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Where this trial is running
Daegu
- Daegu Catholic University Medical Center — Daegu, South Korea (Recruiting)
Study contacts
- Principal investigator: Jeongyoon Choi, PI — Daegu Catholic University Medical Center
- Study coordinator: Hee Suh
- Email: hee1110@yuhan.co.kr
- Phone: +82-2-828-0231
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.