Sjogrens Syndrome Measured by Ultrasound | NCT03411850

Studies
Sjogrens Syndrome Measured by Ultrasound

NCT03411850

Sponsor

Arthritis & Rheumatism Associates, P.C.

Status

Unknown status

Last Update Posted

May 11, 2021Actual

Enrollment

20Actual

Phase

Phase 2

Conditions

Sjogren's Syndrome

Interventions

Orencia
Placebo

Countries

United States

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

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 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

May 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

Jun 30, 2016

First Submission Date that Met QC Criteria

Jan 19, 2018

First Posted Date

Jan 26, 2018Actual

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 10, 2021

Last Update Posted Date

May 11, 2021Actual

Name	Class
Bristol-Myers Squibb	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

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

Ultrasound study focused on salivary gland outcomes in Sjogren's subjects

Detailed Description

A 32 week ultrasound study for subject diagnosed with Sjogren's Syndrome. Subjects will receive Orencia (Abatacept) as intervention therapy during this trial.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Orencia (Abatacept)	Active Comparator	Orencia (Abatacept) Intravenous (IV) or Subcutaneous (SQ) injection	Biological: Orencia
Placebo	Placebo Comparator	Placebo (saline solution) given Intravenous (IV) or Subcutaneous (SQ)	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Orencia	Biological	FDA approved biologic	Orencia (Abatacept)	Abatacept

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Salivary gland changes	Salivary gland changes detected by ultrasound imaging with elastography	32 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects diagnosed with Sjogren's Syndrome

Exclusion Criteria:

Subjects previously diagnosed with Sarcoidsis
Subjects with positive for Hepatitis B, Hepatitis C, HIV
Subjects diagnosed with Cancer within 5 years of screening

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Center for Rheumatology and Bone Research a division of Arthritis and Rheumatism Associates, P.C.		Wheaton	Maryland	20902	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jan 5, 2023
Reset	Jan 31, 2023

Submission Tracking

Estimated Results First Submitted Date

Jan 5, 2023

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 5, 2023			Jan 31, 2023

Condition Browse Module

MeSH Terms

ID	Term
D012859	Sjogren's Syndrome

Ancestor Terms

ID	Term
D001172	Arthritis, Rheumatoid
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069594	Abatacept
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D018796	Immunoconjugates
D000906	Antibodies
D007136	Immunoglobulins
D012712	Serum Globulins

Browse Leaves

Not provided

Browse Branches

Not provided