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Recruiting NCT05835518

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

— Observational Rheumatoid Arthritis Ankylosing Spondylitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis, Ankylosing Spondylitis. Basic parameters: 19 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Primary outcome measures

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

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Daegu Catholic University Medical Center — Daegu

Identifiers

NCT: NCT05835518 · YMC049

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗