NCT03411850

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2016

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

5 years

First QC Date

June 30, 2016

Last Update Submit

May 10, 2021

Conditions

Sjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

  • Salivary gland changes

    Salivary gland changes detected by ultrasound imaging with elastography

    32 weeks

Study Arms (2)

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

OrenciaBIOLOGICAL

FDA approved biologic

Also known as: Abatacept
Orencia (Abatacept)
PlaceboOTHER
Also known as: Saline
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects diagnosed with Sjogren's Syndrome

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Wheaton, Maryland, 20902, United States

Location

MeSH Terms

Conditions

Sjogren's Syndrome

Interventions

AbataceptSodium Chloride

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesDry Eye SyndromesLacrimal Apparatus DiseasesEye DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2016

First Posted

January 26, 2018

Study Start

May 1, 2016

Primary Completion

May 1, 2021

Study Completion

December 1, 2021

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)