Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
24 May 2021 |
Main ID: |
NCT03411850 |
Date of registration:
|
30/06/2016 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Sjogrens Syndrome Measured by Ultrasound
|
Scientific title:
|
Disease Modification in Sjogrens Syndrome Measured by Ultrasound: A Pilot Study |
Date of first enrolment:
|
May 2016 |
Target sample size:
|
20 |
Recruitment status: |
Active, not recruiting |
URL:
|
https://clinicaltrials.gov/show/NCT03411850 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Single (Participant).
|
Phase:
|
Phase 2
|
|
Countries of recruitment
|
United States
| | | | | | | |
Key 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Sjogren's Syndrome
|
Intervention(s)
|
Biological: Orencia
|
Other: Placebo
|
Primary Outcome(s)
|
Salivary gland changes
[Time Frame: 32 weeks]
|
Secondary ID(s)
|
BMS IM101-560
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|