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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05835518
• Other study ID #: YMC049
• Status: Recruiting
• Start date: January 26, 2023
• Est. completion date: August 2026

Study information

• Verified date: April 2023
• Source: Yuhan Corporation
• Contact: Hee Suh
• Phone: +82-2-828-0231
• Email: hee1110[@]yuhan.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 74 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Medical Center	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in quality of life (EQ-5D-5L) scores at 52 weeks from baseline in patients with RA and AS		52weeks