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An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With RA and AS

An Observational, Prospective Study to Assess the Efficacy and Safety of Adalloce in Patients With Rheumatoid Arthritis and Ankylosing Spondylitis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05835518
Enrollment
1000
Registered
2023-04-28
Start date
2023-01-26
Completion date
2026-08-31
Last updated
2023-05-09

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

Conditions

Ankylosing Spondylitis, Rheumatoid Arthritis

Keywords

The Efficacy and Safety of Adalloce

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

Interventions

None listed

Sponsors

Yuhan Corporation
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 74 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Changes in quality of life (EQ-5D-5L) scores at 52 weeks from baseline in patients with RA and AS52weeks

Countries

South Korea

Contacts

Primary ContactHee Suh
hee1110@yuhan.co.kr+82-2-828-0231

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026