Rhupus Syndrome and Efficacy of Etanercept Treatment | NCT02766439

Studies
Rhupus Syndrome and Efficacy of Etanercept Treatment

NCT02766439

Sponsor

Yang Beibei

Status

Completed

Last Update Posted

May 9, 2016Estimated

Enrollment

6Actual

Phase

Not provided

Conditions

Rhupus Syndrome, Etanercept

Interventions

etanercept

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

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2015Actual

First Submitted Date

May 6, 2016

First Submission Date that Met QC Criteria

May 6, 2016

First Posted Date

May 9, 2016Estimated

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 6, 2016

Last Update Posted Date

May 9, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yang Beibei, the First People's Hospital of Chenzhou, First People's Hospital of ChenzhouSponsor-Investigator

Lead Sponsor

Yang BeibeiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

between March 2013 and March 2014, Rhupus patients were enrolled to receive a 25-mg etanercept injection subcutaneously twice a week. The follow-up time of the study was 24 weeks.

Detailed Description

between March 2013 and March 2014, patients who were unresponsive to therapy with corticosteroid and disease-modifying antirheumatic drugs (DMARDs), with a Disease Activity Score in 28 Joints (DAS28) >5.1 were enrolled to receive a 25-mg etanercept injection subcutaneously twice a week. The follow-up time of the study was 24 weeks.

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

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rhupus syndrome, SLE without RA		Rhupus syndrome, SLE without RA	Drug: etanercept

Interventions

Name	Type	Description	Arm Group Labels	Other Names
etanercept	Drug	25-mg etanercept injection subcutaneously twice a week	Rhupus syndrome, SLE without RA

Measure	Description	Time Frame
Disease Activity Score in 28 Joints (DAS28)		24 week

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Rhupus patients who were unresponsive to therapy with corticosteroid and disease-modifying antirheumatic drugs (DMARDs), with a Disease Activity Score in 28 Joints (DAS28) >5.1

Exclusion Criteria:

- those who had participated in other studies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

patients who were unresponsive to therapy with corticosteroid and disease-modifying antirheumatic drugs (DMARDs), with a Disease Activity Score in 28 Joints (DAS28) >5.1 were enrolled

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C000717167	rhupus syndrome

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068800	Etanercept

Ancestor Terms

ID	Term
D007141	Immunoglobulin Fc Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided