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

NCT05835518 | Recruiting

• 1 other identifier: YMC049
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis; Ankylosing Spondylitis

Keywords

The Efficacy and Safety of Adalloce

Outcome Measures

Primary Outcomes (1)

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

  52weeks

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Those diagnosed with RA or AS

You may qualify if:

• Men and women between the ages of over 19 and under 75 at the time of consent
• Patients diagnosed with RA or AS at least 3 months prior to the study registration
• Patients who are scheduled to be prescribed Adalloce according to the doctor's opinions
• Patients who have never received Adalloce
• Patients who voluntarily gave their written consent after being sufficiently explained about the purpose and contents of this study

You may not qualify if:

• Patients with hypersensitivity to this drug or its components
• Patients with active tuberculosis or other severe infection such as sepsis or opportunistic infection
• Patients with moderate to severe heart failure (NYHA class III/IV)
• Patients who are judged to be inappropriate for Adalloce administration according to the approved conditions
• Patients who are not suitable for participation in this study according to the judgment of the investigator
• Patients participating in other drug clinical trials (Adalloce PMS participants cannot participate in this study)

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Daegu Catholic University Medical Center

Daegu, South Korea

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis

Study Officials

• Jeongyoon Choi, PI

  Daegu Catholic University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Suh

CONTACT

+82-2-828-0231; hee1110@yuhan.co.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: January 26, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 9, 2023

Record last verified: 2023-04

Locations

KR (1)