Remission in Rheumatoid Arthritis in the Asian-Pacific Re... | NCT03365856

Studies
Remission in Rheumatoid Arthritis in the Asian-Pacific Region

NCT03365856

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Dec 7, 2017Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

observational study

Countries

Not provided

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

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Estimated

Primary Completion Date

Mar 1, 2018Estimated

Completion Date

Jun 1, 2018Estimated

First Submitted Date

Dec 4, 2017

First Submission Date that Met QC Criteria

Dec 6, 2017

First Posted Date

Dec 7, 2017Actual

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

Dec 6, 2017

Last Update Posted Date

Dec 7, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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 the multi-center, open and cross-sectional study of RA remission in Asia Pacific region. The objectives is to explore remission rate of RA patients in different countries in the Asian-Pacific area using different criteria of remission (DAS28, CDAI, SDAI, ACR/EULA remission criteria, RAPID3 and Clin28) and investigate the associated factors of remission in RA patients.

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

1,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RA patients		As routinary clinical practice and observational study	Other: observational study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observational study	Other	as clinical practice	RA patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
remission rate of RA patients in different countries in the Asian-Pacific area	according to the different criteria of clinical remission in RA patients	12-24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

RA patients fulfilled the American College of Rheumatology 1987 criteria or the 2010 ACR/EULAR classification criteria.
Patients aged > 18 years.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

RA patients in our centres are enrolled consecutively.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ru Li, Dr.	Contact	86-18611616251		doctorliru123@163.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided