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

NCT ID: NCT05835518

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-26

Study Completion Date

2026-08-31

Brief Summary

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

Detailed Description

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Conditions

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Rheumatoid Arthritis Ankylosing Spondylitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

19 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeongyoon Choi, PI

Role: PRINCIPAL_INVESTIGATOR

Daegu Catholic University Medical Center

Locations

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Daegu Catholic University Medical Center

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hee Suh

Role: CONTACT

+82-2-828-0231

Facility Contacts

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Jeongyoon Choi

Role: primary

Other Identifiers

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YMC049

Identifier Type: -

Identifier Source: org_study_id

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