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NCT Number: NCT05835518

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

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

Recruiting

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Key information

Conditions

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

Age range

19 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Daegu Catholic University Medical Center

Daegu, South Korea

Location status: Recruiting

Location contact

Jeongyoon Choi

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

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

    Time frame: 52weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Hee Suh

CONTACT

[email protected]

+82-2-828-0231

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 28, 2023
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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