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

May 8, 2023 updated by: Yuhan Corporation

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

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Recruiting
        • Daegu Catholic University Medical Center
        • Contact:
          • Jeongyoon Choi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Those diagnosed with RA or AS

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in quality of life (EQ-5D-5L) scores at 52 weeks from baseline in patients with RA and AS
Time Frame: 52weeks
52weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuhan Corporation

Investigators

  • Principal Investigator: Jeongyoon Choi, PI, Daegu Catholic University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

August 1, 2026

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YMC049

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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