Systemic Lupus ErythematosusSAGENCT00671047
The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study
An observational study of Systemic Lupus Erythematosus, run by XDx at 12 sites in 2 countries.
Trial summary
The goal of this study is to enable the study sponsor to develop a new blood test method for clinicians to accurately predict which individuals with lupus will flare, when the flare will occur, and flare severity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- non-interventional
- How many people
- 1,000 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Dec 2007to Jun 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- Individual has met the diagnostic criteria for SLE (at least 4 out of the 11) American College of Rheumatology (ACR) criteria and:
- Has experienced specific manifestations of lupus disease activity within the last 12 months including the following:
- Lupus nephritis (kidney disease); vasculitis and or central nervous system involvement and/or:
- Required treatment with at least 20 mg per day of prednisone (or equivalent) and/or:
- Required hospitalization directly due to SLE disease
Who cannot join
- Subjects unable or unlikely to cooperate with the procedures of the protocol
- Substance abuse / dependence that in the opinion of the investigator could compromise the subject's ability to complete the study
- Subject with a more dominant autoimmune disease, e.g. Rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, scleroderma
- History of malignancy within the last five years with the exception of basal cell carcinoma
- Active infection: Known HIV positive status, currently active tuberculosis , active infection receiving antibiotics
- Had tissue or organ transplantation (including bone marrow)
- On chronic hemo- or peritoneal dialysis
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States11 sites
Emory University
Atlanta, Georgia, 30303
State University of New York
Brooklyn, New York, 11203
Metroplex Clinical Research Center
Dallas, Texas, 75235
Kansas University Medical Center
Kansas City, Kansas, 66160
North Shore Long Island Jewish Health System
Lake Success, New York, 11042
Cedars-Sinai Medical Center
Los Angeles, California, 90048
New York University
New York, New York, 10003
Hospital for Special Surgery
New York, New York, 10021
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
East Bay Rheumatology Medical Group
San Leandro, California, 94578
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
The goal of this study is to enable the study sponsor to develop a new blood test method for clinicians to accurately predict which individuals with lupus will flare, when the flare will occur, and flare severity. Ultimately such a newly derived test would allow treating physicians to start pre-emptive therapy early, with the goal of achieving remission quickly and with a shorter duration of treatment; identify individuals who will have less severe flares and will thus require less aggressive treatments; or intensify and lengthen treatment for those individuals who will need such therapy.
The design of this study is to follow individuals with a known diagnosis of SLE for changes in disease activity during the course of one year of observation. Clinical data and blood and urine samples will be collected at scheduled monthly visits. The clinical data and blood samples will be used for identifying gene expression profile(s) that are associated with increases in SLE disease activity (lupus "flares").
Read the detailed description
This study is currently enrolling individuals who have an established diagnosis of SLE to participate. There is no cost to volunteers who participate and the study pays for the visits to the clinics for monthly collection of clinical information and blood and urine samples. Women who are or become pregnant may participate in the study with the recommendation of their health care providers and the study doctors.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- non-interventional
- Keywords
- Autoimmune Diseases, Lupus
- Medical subject headings
- Lupus Erythematosus, Systemic, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventionalOther
SLE nature history observational
| Study group | Role | What they receive |
|---|---|---|
| 1 | SLE subjects with flares in the last 12 months in specific organ systems. Receives: Other: non-interventional |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study startDec 2007
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James Yee, MD, Ph.D., Study director, XDx, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671047
- Sponsor's protocol ID
- SL105
- Acronym
- SAGE
- Status last verified
- Dec 2008
- First submitted
- 30 Apr 2008
- Last updated
- 31 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Systemic Lupus Erythematosus (SLE) Activity Gene Expression (SAGE) Study
- ClinicalTrials.gov ID
- NCT00671047
- Acronym / sponsor ID
- SAGE / SL105
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Autoimmune Diseases, Lupus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- XDxIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 2 May 2008 (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.
The goal of this study is to enable the study sponsor to develop a new blood test method for clinicians to accurately predict which individuals with lupus will flare, when the flare will occur, and flare severity. Ultimately such a newly derived test would allow treating physicians to start pre-emptive therapy early, with the goal of achieving remission quickly and with a shorter duration of treatment; identify individuals who will have less severe flares and will thus require less aggressive treatments; or intensify and lengthen treatment for those individuals who will need such therapy.
The design of this study is to follow individuals with a known diagnosis of SLE for changes in disease activity during the course of one year of observation. Clinical data and blood and urine samples will be collected at scheduled monthly visits. The clinical data and blood samples will be used for identifying gene expression profile(s) that are associated with increases in SLE disease activity (lupus "flares").
Detailed description
This study is currently enrolling individuals who have an established diagnosis of SLE to participate. There is no cost to volunteers who participate and the study pays for the visits to the clinics for monthly collection of clinical information and blood and urine samples. Women who are or become pregnant may participate in the study with the recommendation of their health care providers and the study doctors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: non-interventionalSLE subjects with flares in the last 12 months in specific organ systems. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (5 listed)
- Individual has met the diagnostic criteria for SLE (at least 4 out of the 11) American College of Rheumatology (ACR) criteria and:
- Has experienced specific manifestations of lupus disease activity within the last 12 months including the following:
Key exclusion criteria (7 listed)
- Subjects unable or unlikely to cooperate with the procedures of the protocol
- Substance abuse / dependence that in the opinion of the investigator could compromise the subject's ability to complete the study
- Subject with a more dominant autoimmune disease, e.g. Rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, scleroderma
- History of malignancy within the last five years with the exception of basal cell carcinoma
- Active infection: Known HIV positive status, currently active tuberculosis , active infection receiving antibiotics
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 |
|---|---|---|
| non-interventionalSLE nature history observational | Other | 1 |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2008.
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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.
James Yee, MD, Ph.D. study director
XDx, Inc.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by XDx at 12 sites in 2 countries.
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 5 inclusion and 7 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 31 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Canada. 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?
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.
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 31 Dec 2008.