Sjogrens Syndrome Measured by Ultrasound

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03411850
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Arthritis & Rheumatism Associates, P.C.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Sjogren's Syndrome
Additional Details

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

Arms & Interventions

Arms

Active Comparator: Orencia (Abatacept)

Orencia (Abatacept) Intravenous (IV) or Subcutaneous (SQ) injection

Placebo Comparator: Placebo

Placebo (saline solution) given Intravenous (IV) or Subcutaneous (SQ)

Interventions

Biological: - Orencia

FDA approved biologic

Other: - Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Wheaton, Maryland

Status

Recruiting

Address

The Center for Rheumatology and Bone Research a division of Arthritis and Rheumatism Associates, P.C.

Wheaton, Maryland, 20902

Site Contact

Theresa Bass-Goldman

[email protected]

301-942-6610