Sjogren's SyndromePhase 2NCT03411850
Sjogrens Syndrome Measured by Ultrasound
A Phase 2 study testing Orencia in people with Sjogren's Syndrome, run by Arthritis & Rheumatism Associates, P.C. at 1 site in United States.
Trial summary
Ultrasound study focused on salivary gland outcomes in Sjogren's subjects Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- Orencia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects diagnosed with Sjogren's Syndrome
Who cannot join
- Subjects previously diagnosed with Sarcoidsis
- Subjects with positive for Hepatitis B, Hepatitis C, HIV
- Subjects diagnosed with Cancer within 5 years of screening
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Rheumatology and Bone Research a division of Arthritis and Rheumatism Associates, P.C.
Wheaton, Maryland, 20902
About this study
Official title: Disease Modification in Sjogrens Syndrome Measured by Ultrasound: A Pilot Study
Ultrasound study focused on salivary gland outcomes in Sjogren's subjects
Read the 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.
- Conditions
- Sjogren's Syndrome
- Being tested
- Orencia, Placebo
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrenciaBiological
Also called Abatacept
FDA approved biologic
PlaceboOther
Also called Saline
| Study group | Role | What they receive |
|---|---|---|
| Orencia (Abatacept) | Active comparator | Orencia (Abatacept) Intravenous (IV) or Subcutaneous (SQ) injection Receives: Biological: Orencia |
| Placebo | Placebo comparator | Placebo (saline solution) given Intravenous (IV) or Subcutaneous (SQ) Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary gland changes
Salivary gland changes detected by ultrasound imaging with elastography
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study startMay 2016
- Primary completionMay 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthritis & Rheumatism Associates, P.C.
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411850
- Sponsor's protocol ID
- BMS IM101-560
- Status last verified
- May 2021
- First submitted
- 30 Jun 2016
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Modification in Sjogrens Syndrome Measured by Ultrasound: A Pilot Study
- ClinicalTrials.gov ID
- NCT03411850
- Acronym / sponsor ID
- BMS IM101-560
- Conditions
- Sjogren's Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Arthritis & Rheumatism Associates, P.C.University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- May 2016
- Primary completion
- May 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ultrasound study focused on salivary gland outcomes in Sjogren's subjects
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orencia (Abatacept) | Active comparator | Biological: OrenciaOrencia (Abatacept) Intravenous (IV) or Subcutaneous (SQ) injection |
| Placebo | Placebo comparator | Other: PlaceboPlacebo (saline solution) given Intravenous (IV) or Subcutaneous (SQ) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects diagnosed with Sjogren's Syndrome
Key exclusion criteria (3 listed)
- Subjects previously diagnosed with Sarcoidsis
- Subjects with positive for Hepatitis B, Hepatitis C, HIV
- Subjects diagnosed with Cancer within 5 years of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrenciaAlso: AbataceptFDA approved biologic | Biological | Orencia (Abatacept) |
| PlaceboAlso: Saline | Other | Placebo |
Primary outcome
Salivary gland changes
Time frame: 32 weeks
Salivary gland changes detected by ultrasound imaging with elastography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Orencia in people with Sjogren's Syndrome, run by Arthritis & Rheumatism Associates, P.C. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary gland changes (time frame: 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.