Sjogrens Syndrome Measured by Ultrasound

May 10, 2021 updated by: Arthritis & Rheumatism Associates, P.C.

Disease Modification in Sjogrens Syndrome Measured by Ultrasound: A Pilot Study

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • The Center for Rheumatology and Bone Research a division of Arthritis and Rheumatism Associates, P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Orencia (Abatacept)
Orencia (Abatacept) Intravenous (IV) or Subcutaneous (SQ) injection
Biological: Orencia
FDA approved biologic
Other Names:
  • Abatacept
Placebo Comparator: Placebo
Placebo (saline solution) given Intravenous (IV) or Subcutaneous (SQ)
Other: Placebo
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arthritis & Rheumatism Associates, P.C.

Collaborators

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

January 19, 2018

First Posted (Actual)

January 26, 2018

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 10, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMS IM101-560

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sjogren's Syndrome

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jordan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe