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Sjogrens Syndrome Measured by Ultrasound

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ClinicalTrials.gov Identifier: NCT03411850
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : January 26, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Arthritis & Rheumatism Associates, P.C.

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

Condition or disease Intervention/treatment Phase
Sjogren's Syndrome Biological: Orencia Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Disease Modification in Sjogrens Syndrome Measured by Ultrasound: A Pilot Study
Study Start Date : May 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Arm Intervention/treatment
Active Comparator: Orencia (Abatacept)
Orencia (Abatacept) Intravenous (IV) or Subcutaneous (SQ) injection
Biological: Orencia
FDA approved biologic
Other Name: Abatacept

Placebo Comparator: Placebo
Placebo (saline solution) given Intravenous (IV) or Subcutaneous (SQ)
Other: Placebo
Other Name: Saline




Primary Outcome Measures :
  1. Salivary gland changes [ Time Frame: 32 weeks ]
    Salivary gland changes detected by ultrasound imaging with elastography



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03411850


Contacts
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Contact: Theresa Bass-Goldman 301 942-6610 tbgoldman@arapc.com
Contact: Deborah Contreras 301 942-6610 dcontreras@arapc.com

Locations
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United States, Maryland
The Center for Rheumatology and Bone Research a division of Arthritis and Rheumatism Associates, P.C. Recruiting
Wheaton, Maryland, United States, 20902
Contact: Theresa Bass-Goldman    301-942-6610    tbgoldman@arapc.com   
Principal Investigator: Paul J DeMarco, MD         
Sub-Investigator: Alan K Matsumoto, MD         
Sub-Investigator: Herbert S Baraf, MD         
Sub-Investigator: Robert L Rosenberg, MD         
Sub-Investigator: Evan L Siegel, MD         
Sub-Investigator: Ashley D Beall, MD         
Sub-Investigator: Nicole Sadddic-Thomas, MD         
Sub-Investigator: Grace E Ahn, MD         
Sub-Investigator: Jeffrey A Potter, MD         
Sponsors and Collaborators
Arthritis & Rheumatism Associates, P.C.
Bristol-Myers Squibb

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Responsible Party: Arthritis & Rheumatism Associates, P.C.
ClinicalTrials.gov Identifier: NCT03411850     History of Changes
Other Study ID Numbers: BMS IM101-560
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Xerostomia
Mouth Diseases
Dry Eye Syndromes
Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents