Systemic Lupus ErythematosusPhase 1/2NCT00519363
Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors
A Phase 1/2 study testing atorvastatin in people with Systemic Lupus Erythematosus, run by The Center for Rheumatic Disease, Allergy, & Immunology at 1 site in United States.
Trial summary
This is an open label pilot clinical trial on a cohort of 15 Lupus patients from the Center for Rheumatic Disease. Clinical evaluations and laboratory tests will be done and then if eligible, the patients will receive oral atorvastatin, at a fixed dose of 40mg/day. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- atorvastatin
- Type of treatment
- Pill or oral medicine
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Dec 2008
- Phase
- Phase 1/2
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60, female
- have at least four ACR criteria for SLE
- SLEDAI score > 4
- LDL cholesterol level from 100-190mg/dl
Who cannot join
- Pregnant, lactating, or wanting to become pregnant
- unable to take atorvastatin due to allergy, liver disease, elevated lever function test, myositis, or eleveated CPK
- already on lipid lowering therapy
- participating in another lupus study
- on drugs such as: amiodarone, clarithromycin, clclosporine, erythromycin, itraconazole, ketoconazole, nefazodone, verapamil, protease inhibitors, niacin, digoxin, cholestryrmine, colestipol
- has a diagnosis of myositis
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Rheumatic Disease, Allergy, and Immunology
Kansas City, Missouri, 64111
About this study
Official title: Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors.
This is an open label pilot clinical trial on a cohort of 15 Lupus patients from the Center for Rheumatic Disease. Clinical evaluations and laboratory tests will be done and then if eligible, the patients will receive oral atorvastatin, at a fixed dose of 40mg/day. Statins have been shown to induce clinical improvement in rheumatoid arthritis patients, as well as lupus patients. The effectiveness has been noted within 8 to 14 days, we will do our study for 3 months. Clinical and laboratory tests will be checked at the 1 and 3 month interval. We hypothesize that statin drugs (atorvastatin) slow the progression of SLE(Systemic Lupus Erythematosus) disease activity and down regulates TLR(Toll-like receptors) 2,4,and 9 pathways in addition to lowering lipid levels.
Read the detailed description
Atorvastin (Lipitor) is a commonly used drug approved by the FDA for treatment of dyslipidemias. It is a relatively safe drug to use with periodic monitoring.
Eligibility critera:
- age 18-60, females, as a marjority of lupus patients are female
- at least 4 ACR (American College of Rheumatology) criteria of SLE(Systemic Lupus Erythematosus)
- Moderate to Severe disease activity using approved SLEDAI(Systemic Lupus Erythematosus Disease Activity Index)
- LDL cholesterol 100-190mg/dl
Exclusion criteria:
- Pregnancy, and or lactating or wants to get pregnant
- Unable to take atorvastatin due to allergy, liver disease, elevated liver functions, myositis, or elvated CPK(creatine phosphakinase)
- already on lipid lowering therapy
- already on amiodarone, clarithromycin, cyclosporin, erythromycin, itraconazole, ketoconazole, nefazodone, verapamil, protease inhibitors, niacin, digoxin,k cholestyramine, colestipol
- has a dianosis of Myositis. Our goal is to colledt preliminary data to see if there is a trend for the efficacy of atorvastatin in ameliorating SLE disease activity and to evaluate TLRs(Toll-like receptor) in SLE patients. A p value of <0.05 will be considered statistically significant. Our baseline and at subsequent visits, we will have 80% power to detect a minimum of 34%-39% difference for most of the continous variables measured at different intervals.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- atorvastatin
- Keywords
- Lupus, TLR's, Hyperlipidemia, age eighteen to sixty, female with SLE, SLEDAI, greater than four, LDL cholesterol elevated
- Medical subject headings
- Lupus Erythematosus, Systemic, Hyperlipidemias, Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
Also called Lipitor 40mg
atorvastatin 40mg, given orally daily for 3 months.
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease the SLEDAI level of female lupus patients, down regulate the TLR 2,4, and 9.
Measured: 3 months
Secondary outcomes (1)
lower lipid levels in female lupus patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionOct 2008
- Study completionDec 2008
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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Center for Rheumatic Disease, Allergy, & Immunology
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Luke's Health System
- Investigators
- Nabih I Abdou, MD, PhD, Principal investigator, The Center for Rheumatic Disease, Allergy, and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519363
- Sponsor's protocol ID
- 06-316
- Other IDs
- Saint, Luke's, Hospital, Grant
- Status last verified
- Sep 2009
- First submitted
- 20 Aug 2007
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statins and Lupus: Effects of Statins on Clinical Lupus Parameters, Serological Markers and Toll-like Receptors.
- ClinicalTrials.gov ID
- NCT00519363
- Acronym / sponsor ID
- 06-316
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus, TLR's, Hyperlipidemia, age eighteen to sixty, female with SLE, SLEDAI, greater than four, LDL cholesterol elevated
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The Center for Rheumatic Disease, Allergy, & ImmunologyUniversity, hospital or other
- Collaborators
- Saint Luke's Health System
- Study start
- Sep 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 22 Aug 2007 (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.
This is an open label pilot clinical trial on a cohort of 15 Lupus patients from the Center for Rheumatic Disease. Clinical evaluations and laboratory tests will be done and then if eligible, the patients will receive oral atorvastatin, at a fixed dose of 40mg/day. Statins have been shown to induce clinical improvement in rheumatoid arthritis patients, as well as lupus patients. The effectiveness has been noted within 8 to 14 days, we will do our study for 3 months. Clinical and laboratory tests will be checked at the 1 and 3 month interval. We hypothesize that statin drugs (atorvastatin) slow the progression of SLE(Systemic Lupus Erythematosus) disease activity and down regulates TLR(Toll-like receptors) 2,4,and 9 pathways in addition to lowering lipid levels.
Detailed description
Atorvastin (Lipitor) is a commonly used drug approved by the FDA for treatment of dyslipidemias. It is a relatively safe drug to use with periodic monitoring.
Eligibility critera:
- age 18-60, females, as a marjority of lupus patients are female
- at least 4 ACR (American College of Rheumatology) criteria of SLE(Systemic Lupus Erythematosus)
- Moderate to Severe disease activity using approved SLEDAI(Systemic Lupus Erythematosus Disease Activity Index)
- LDL cholesterol 100-190mg/dl
Exclusion criteria:
- Pregnancy, and or lactating or wants to get pregnant
- Unable to take atorvastatin due to allergy, liver disease, elevated liver functions, myositis, or elvated CPK(creatine phosphakinase)
- already on lipid lowering therapy
- already on amiodarone, clarithromycin, cyclosporin, erythromycin, itraconazole, ketoconazole, nefazodone, verapamil, protease inhibitors, niacin, digoxin,k cholestyramine, colestipol
- has a dianosis of Myositis. Our goal is to colledt preliminary data to see if there is a trend for the efficacy of atorvastatin in ameliorating SLE disease activity and to evaluate TLRs(Toll-like receptor) in SLE patients. A p value of <0.05 will be considered statistically significant. Our baseline and at subsequent visits, we will have 80% power to detect a minimum of 34%-39% difference for most of the continous variables measured at different intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60, female
- have at least four ACR criteria for SLE
- SLEDAI score > 4
- LDL cholesterol level from 100-190mg/dl
Key exclusion criteria (6 listed)
- Pregnant, lactating, or wanting to become pregnant
- unable to take atorvastatin due to allergy, liver disease, elevated lever function test, myositis, or eleveated CPK
- already on lipid lowering therapy
- participating in another lupus study
- on drugs such as: amiodarone, clarithromycin, clclosporine, erythromycin, itraconazole, ketoconazole, nefazodone, verapamil, protease inhibitors, niacin, digoxin, cholestryrmine, colestipol
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 |
|---|---|---|
| atorvastatinAlso: Lipitor 40mgatorvastatin 40mg, given orally daily for 3 months. | Drug | – |
Primary outcome
decrease the SLEDAI level of female lupus patients, down regulate the TLR 2,4, and 9.
Time frame: 3 months
1 secondary outcome
lower lipid levels in female lupus patients
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2010.
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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.
Nabih I Abdou, MD, PhD principal investigator
The Center for Rheumatic Disease, Allergy, and Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing atorvastatin in people with Systemic Lupus Erythematosus, run by The Center for Rheumatic Disease, Allergy, & Immunology 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 24 Mar 2010. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
decrease the SLEDAI level of female lupus patients, down regulate the TLR 2,4, and 9. (time frame: 3 months). 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 24 Mar 2010.