Sjogren's SyndromeNCT02123147
Examining the Immunological Process of Autoimmune Patients
An observational study of Sjogren's Syndrome and Autoimmune Diseases, run by University of Florida at 1 site in United States.
Trial summary
Sjögren's syndrome (SjS) is an autoimmune disease characterized primarily by exocrine gland dysfunction, specifically of the salivary and lacrimal glands, resulting in dry mouth and dry eyes symptoms. Read more about this study
- Who is it for?
- Ages 9 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Sjogren's Syndrome, Autoimmune Diseases, Dry Eyes
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Aug 2016
- Phase
- Observational
- 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 9 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 150 Sjogren's syndrome patients and 50 healthy controls.
Who may be able to join
- Primary Sjogren's syndrome patients: primary Sjogren's syndrome patients who meet the revised criteria for SjS diagnosis by the American-European Consensus Group.
- Secondary Sjogren's syndrome patients: secondary Sjogren's syndrome patients who meet the criteria for primary Sjogren's syndrome in association with other autoimmune diseases such as systemic lupus erythematosus , dermatomyositis, scleroderma, idiopathic arthritis, mixed connective tissue disease, etc.
- -Subjects who does not have history of autoimmune diseases.
Who cannot join
- Pregnant women.
- Patients with history of lymphoma or malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Sjögren's syndrome (SjS) is an autoimmune disease characterized primarily by exocrine gland dysfunction, specifically of the salivary and lacrimal glands, resulting in dry mouth and dry eyes symptoms. It can be systemic by affecting other organs including the gastrointestinal tract, skin, lungs, vasculature, kidneys, bladder and vagina. Involvement of the musculature can lead to fibromyalgia-like symptoms and chronic fatigue, while approximately 20% of patients develop various neuropathies, including sensory, peripheral, cranial and myelopathic neuropathies exhibited by cognitive impairments such as dementia, lack of concentration, memory loss and various psychiatric disorders. Like most autoimmune connective tissue diseases, SjS shows a sexual dimorphism with women affected 10-times more frequently than men, suggesting a role for sex hormones in disease susceptibility or progression. One common feature of SjS is it infiltration of mononuclear cells into the salivary and lacrimal glands, aggregating into clusters referred to as lymphocytic foci (LF). Critical to the studies proposed is the fact that a predominant cell population of LF is the pathogenic TH17 cell that produces IL-17 cytokine and autoreactive B cells reactive to M3R, Ro, and La autoantigens. The goal of this study is characterize the change in receptor gene repertoires of autoreactive B and T cells at different time points during the disease process and examine the correlation with various disease parameters.
Read the detailed description
Blood from patient and healthy controls will be collected once every 3-6 months. White blood cells from blood samples will be separated. Tests will be done to see which substances these cells make. Using sequencing techniques, the investigators will determine the genetic code of the receptors expressed on these cells. The investigators plan to test how these cells change over the period of at least 3 years at different visits. In addition, the investigators will check how these changes relate to patients' general medical history relevant to autoimmune disease, lab results and physical examinations and exams pertinent to the diagnosis of autoimmune disease, and psychosocial data.
- Conditions
- Sjogren's Syndrome, Autoimmune Diseases, Dry Eyes, Dry Mouth
- Medical subject headings
- Sjogren's Syndrome, Autoimmune Diseases, Dry Eye Syndromes, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sjogren's syndrome | Patients who are diagnosed with Sjogren's syndrome. Blood will be collected once every 3-6 months for up to 3 years. | |
| Healthy Control | Patients who are diagnosed with healthy control. Blood will be collected once every 6 months for up to 3 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receptor gene rearrangement.
Gene arrangement of the receptors in patients will be assessed every 3 months for 3 years.
Measured: Every 3 months for 3 years
Receptor gene rearrangement
Gene arrangement of the receptors in healthy controls will be assessed every 6 months for 3 years.
Measured: Every 6 months for 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Why it stopped: due to the lack of funding to continue
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.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cuong Nguyen, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123147
- Sponsor's protocol ID
- IRB201400079
- Status last verified
- Aug 2017
- First submitted
- 16 Apr 2014
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Immunological Process of Autoimmune Patients
- ClinicalTrials.gov ID
- NCT02123147
- Acronym / sponsor ID
- IRB201400079
- Conditions
- Sjogren's Syndrome, Autoimmune Diseases, Dry Eyes, Dry Mouth
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: due to the lack of funding to continue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 25 Apr 2014 (estimated)
- 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.
Sjögren's syndrome (SjS) is an autoimmune disease characterized primarily by exocrine gland dysfunction, specifically of the salivary and lacrimal glands, resulting in dry mouth and dry eyes symptoms. It can be systemic by affecting other organs including the gastrointestinal tract, skin, lungs, vasculature, kidneys, bladder and vagina. Involvement of the musculature can lead to fibromyalgia-like symptoms and chronic fatigue, while approximately 20% of patients develop various neuropathies, including sensory, peripheral, cranial and myelopathic neuropathies exhibited by cognitive impairments such as dementia, lack of concentration, memory loss and various psychiatric disorders. Like most autoimmune connective tissue diseases, SjS shows a sexual dimorphism with women affected 10-times more frequently than men, suggesting a role for sex hormones in disease susceptibility or progression. One common feature of SjS is it infiltration of mononuclear cells into the salivary and lacrimal glands, aggregating into clusters referred to as lymphocytic foci (LF). Critical to the studies proposed is the fact that a predominant cell population of LF is the pathogenic TH17 cell that produces IL-17 cytokine and autoreactive B cells reactive to M3R, Ro, and La autoantigens. The goal of this study is characterize the change in receptor gene repertoires of autoreactive B and T cells at different time points during the disease process and examine the correlation with various disease parameters.
Detailed description
Blood from patient and healthy controls will be collected once every 3-6 months. White blood cells from blood samples will be separated. Tests will be done to see which substances these cells make. Using sequencing techniques, the investigators will determine the genetic code of the receptors expressed on these cells. The investigators plan to test how these cells change over the period of at least 3 years at different visits. In addition, the investigators will check how these changes relate to patients' general medical history relevant to autoimmune disease, lab results and physical examinations and exams pertinent to the diagnosis of autoimmune disease, and psychosocial data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sjogren's syndrome | – | –Patients who are diagnosed with Sjogren's syndrome. Blood will be collected once every 3-6 months for up to 3 years. |
| Healthy Control | – | –Patients who are diagnosed with healthy control. Blood will be collected once every 6 months for up to 3 years. |
Who may qualify
- Ages
- 9 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 150 Sjogren's syndrome patients and 50 healthy controls.
Key inclusion criteria (3 listed)
- Primary Sjogren's syndrome patients: primary Sjogren's syndrome patients who meet the revised criteria for SjS diagnosis by the American-European Consensus Group.
- Secondary Sjogren's syndrome patients: secondary Sjogren's syndrome patients who meet the criteria for primary Sjogren's syndrome in association with other autoimmune diseases such as systemic lupus erythematosus , dermatomyositis, scleroderma, idiopathic arthritis, mixed connective tissue disease, etc.
- -Subjects who does not have history of autoimmune diseases.
Key exclusion criteria (2 listed)
- Pregnant women.
- Patients with history of lymphoma or malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Receptor gene rearrangement.
Time frame: Every 3 months for 3 years
Gene arrangement of the receptors in patients will be assessed every 3 months for 3 years.
Receptor gene rearrangement
Time frame: Every 6 months for 3 years.
Gene arrangement of the receptors in healthy controls will be assessed every 6 months for 3 years.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
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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.
Cuong Nguyen, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjogren's Syndrome and Autoimmune Diseases, run by University of Florida 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 8 Aug 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Receptor gene rearrangement. (time frame: Every 3 months for 3 years). The study lists 2 primary outcomes in all. 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 8 Aug 2017.