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An observational, prospective study to assess the efficacy and safety of Adalloce in patients with Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS)

An observational, prospective study to assess the efficacy and safety of Adalloce in patients with Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009141
Enrollment
1000
Registered
2024-01-29
Start date
2023-02-28
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Yuhan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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)

Design outcomes

Primary

MeasureTime frame
Changes in quality of life (EQ-5D-5L) scores at 52 weeks from baseline in patients with RA and AS

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactJung-Yoon Choe

Daegu Catholic University Medical Center

jychoe@cu.ac.kr+82-53-850-3114

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026