An Observational, Prospective Study to Assess the Efficac... | NCT05835518

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

NCT05835518

Sponsor

Yuhan Corporation

Status

Recruiting

Last Update Posted

May 9, 2023Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Rheumatoid Arthritis
Ankylosing Spondylitis

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 26, 2023Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Aug 2026Estimated

First Submitted Date

Apr 18, 2023

First Submission Date that Met QC Criteria

Apr 18, 2023

First Posted Date

Apr 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2023

Last Update Posted Date

May 9, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Those diagnosed with RA or AS

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hee Suh	Contact	+82-2-828-0231		hee1110@yuhan.co.kr

Overall Officials

Name	Affiliation	Role
Jeongyoon Choi, PI	Daegu Catholic University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Daegu Catholic University Medical Center	Recruiting	Daegu			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid
D013167	Spondylitis, Ankylosing

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided