Systemic Lupus ErythematosusPhase 2/3NCT00432354
An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus
A Phase 2/3 study testing atorvastatin in people with Systemic Lupus Erythematosus, run by Buddhist Tzu Chi General Hospital at 2 sites in Taiwan.
Trial summary
The aim of this study is to to determine whether atorvastatin 40mg per day is effective in the treatment of SLE. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- atorvastatin
- How many people
- 40 participants
- Where
- 2 sitesTaiwan
- Study dates
- Mar 2007to Mar 2009
- Phase
- Phase 2/3
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16-80 years of age, fulfilling ACR criteria for the classification of SLE (no limit on disease duration)
- Active disease status including (1) active nephritis with moderate proteinuria (between 1.0gm/day and 2.5gm/day) despite ongoing immunosuppressive therapy or (2) moderate active extra-renal component of the SLEDAI score in the range of 3 to 10. The SLE-DAI score should have been stable for at least two weeks prior to screening.
- The type and number immunosuppressive agents were not changed in recent one months
Who cannot join
- inability to give informed consent;
- myositis (CK>3×normal value);
- dialysis or serum creatinin>2.5mg/dL;
- abnormal liver function (ALT>3×normal value);
- pregnant or breastfeeding;
- life-threatening illness that would interfere with ability to complete the study;
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- current drug or alcohol abuse
- Already under statin therapy
- Active SLE disease need added new immunosuppressive agent or increased current drug dosage for more than 50%.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Dalin Tzu Chi General Hospital
Chiayi City, Chia-yi, 622
Ming-Chi Lu, MD, 05-2648000 ext. 5201, e360187@yahoo.com.tw
Ning-Sheng Lai, MD, Phd, 05-2648000 ext. 5006
- Not yet recruiting
Buddhist Dalin Tzu Chi General Hospital
Chiayi City, 622
Ming-Chi Lu, MD, 886-5-2648000 ext. 5201, e360187@yahoo.com.tw
Ming-Chi Lu, MD
About this study
The aim of this study is to to determine whether atorvastatin 40mg per day is effective in the treatment of SLE.
Read the detailed description
Background: Statins are lipid-lower agents with pleiotropic effects. Beyond the traditional effect as inhibitors of 3-hydroxy-3methylglytaryl coenzyme A (HMG-CoA) reductase, it has anti-inflammatory and immunomodulatory properties. The administration of atorvastatin to lupus-prone model NZB/W F1 mice results in a significant reduction in serum IgG anti-dsDNA Abs and decreased proteinuria. In a pilot study with three patients with SLE, simvastatin induced rapid and significant reduction in proteinuria levels. However, further randomized double-blinded placebo-controlled study is pending.
Objective: The goal of this study was to evaluate the clinical efficacy and laboratory effect of atorvastatin in SLE.
Methods: Forty patients with SLE will randomize in two groups to receive atorvastatin or not as an adjuvant to immunosuppressive agent therapy. Patients who received atorvastatin for 6 months will stop atorvastatin for 8 weeks as a washout period. We will cross over the placebo and experimental groups, then given atorvastatin for another 6 months. Primary outcome is improvement of lupus disease status measured by SLEDAI and microcirculation improvement via nailfold capillaroscopy.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- atorvastatin
- Keywords
- statin, systemic lupus erythematosus, microcirculation
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was the change in SLE-DAI, a validated composite disease activity score.
Secondary outcomes (1)
The secondary endpoint was the improvement of microcirculation evaluated by Raynaud's condition score and nailfold capillaroscopy in the beginning and end of the atorvastatin.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2007 (estimated)
- Study startMar 2007
- Study completionMar 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Ning-Sheng Lai, MD., Ph.D., Study chair, Vice President of Buddhist Dalin Chi Tzu General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00432354
- Sponsor's protocol ID
- DTCRD 96-03
- Status last verified
- Mar 2007
- First submitted
- 6 Feb 2007
- Last updated
- 20 Mar 2007
- Results posted
- No
Publications
Kiss E, Soltesz P, Der H, Kocsis Z, Tarr T, Bhattoa H, Shoenfeld Y, Szegedi G. Reduced flow-mediated vasodilation as a marker for cardiovascular complications in lupus patients. J Autoimmun. 2006 Dec;27(4):211-7. doi: 10.1016/j.jaut.2006.09.008. Epub 2006 Nov 7.
PubMed 17088047McCarey DW, McInnes IB, Madhok R, Hampson R, Scherbakov O, Ford I, Capell HA, Sattar N. Trial of Atorvastatin in Rheumatoid Arthritis (TARA): double-blind, randomised placebo-controlled trial. Lancet. 2004 Jun 19;363(9426):2015-21. doi: 10.1016/S0140-6736(04)16449-0.
PubMed 15207950
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Labeled Pilot Study of Atorvastatin in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00432354
- Acronym / sponsor ID
- DTCRD 96-03
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- statin, systemic lupus erythematosus, microcirculation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Mar 2007
- Study completion
- Mar 2009 (estimated)
- First posted
- 7 Feb 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.
The aim of this study is to to determine whether atorvastatin 40mg per day is effective in the treatment of SLE.
Detailed description
Background: Statins are lipid-lower agents with pleiotropic effects. Beyond the traditional effect as inhibitors of 3-hydroxy-3methylglytaryl coenzyme A (HMG-CoA) reductase, it has anti-inflammatory and immunomodulatory properties. The administration of atorvastatin to lupus-prone model NZB/W F1 mice results in a significant reduction in serum IgG anti-dsDNA Abs and decreased proteinuria. In a pilot study with three patients with SLE, simvastatin induced rapid and significant reduction in proteinuria levels. However, further randomized double-blinded placebo-controlled study is pending.
Objective: The goal of this study was to evaluate the clinical efficacy and laboratory effect of atorvastatin in SLE.
Methods: Forty patients with SLE will randomize in two groups to receive atorvastatin or not as an adjuvant to immunosuppressive agent therapy. Patients who received atorvastatin for 6 months will stop atorvastatin for 8 weeks as a washout period. We will cross over the placebo and experimental groups, then given atorvastatin for another 6 months. Primary outcome is improvement of lupus disease status measured by SLEDAI and microcirculation improvement via nailfold capillaroscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 16-80 years of age, fulfilling ACR criteria for the classification of SLE (no limit on disease duration)
- Active disease status including (1) active nephritis with moderate proteinuria (between 1.0gm/day and 2.5gm/day) despite ongoing immunosuppressive therapy or (2) moderate active extra-renal component of the SLEDAI score in the range of 3 to 10. The SLE-DAI score should have been stable for at least two weeks prior to screening.
- The type and number immunosuppressive agents were not changed in recent one months
Key exclusion criteria (9 listed)
- inability to give informed consent;
- myositis (CK>3×normal value);
- dialysis or serum creatinin>2.5mg/dL;
- abnormal liver function (ALT>3×normal value);
- pregnant or breastfeeding;
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 |
|---|---|---|
| atorvastatin | Drug | – |
Primary outcome
The primary outcome was the change in SLE-DAI, a validated composite disease activity score.
1 secondary outcome
The secondary endpoint was the improvement of microcirculation evaluated by Raynaud's condition score and nailfold capillaroscopy in the beginning and end of the atorvastatin.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2007.
- Background: PubMed 17088047Kiss E, Soltesz P, Der H, Kocsis Z, Tarr T, Bhattoa H, Shoenfeld Y, Szegedi G. Reduced flow-mediated vasodilation as a marker for cardiovascular complications in lupus patients. J Autoimmun. 2006 Dec;27(4):211-7. doi: 10.1016/j.jaut.2006.09.008. Epub 2006 Nov 7.
- Results publication: PubMed 15207950McCarey DW, McInnes IB, Madhok R, Hampson R, Scherbakov O, Ford I, Capell HA, Sattar N. Trial of Atorvastatin in Rheumatoid Arthritis (TARA): double-blind, randomised placebo-controlled trial. Lancet. 2004 Jun 19;363(9426):2015-21. doi: 10.1016/S0140-6736(04)16449-0.
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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.
Ning-Sheng Lai, MD., Ph.D. study chair
Vice President of Buddhist Dalin Chi Tzu General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing atorvastatin in people with Systemic Lupus Erythematosus, run by Buddhist Tzu Chi General Hospital at 2 sites in Taiwan.
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 9 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 20 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Ming-Chi Lu, MD (886-5-2648000 ext. 5201, e360187@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was the change in SLE-DAI, a validated composite disease activity score.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00432354, which also lists 2 linked publications.
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 20 Mar 2007.