Effects of a three-month course of rosuvastatin in patients with Systemic Lupus Erythematosus
| ISRCTN | ISRCTN63412511 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63412511 |
| Secondary identifying numbers | N/A |
- Submission date
- 12/03/2008
- Registration date
- 26/03/2008
- Last edited
- 26/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Hugo ten Cate
Scientific
Scientific
Department of Internal Medicine
Academisch Ziekenhuis Maastricht
Maastricht
6229 HX
Netherlands
| H.Tencate@BIOCH.unimaas.nl |
Study information
| Study design | Randomised, open-labelled, cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Rosuvastatin in SLE |
| Study objectives | Systemic lupus erythematosus (SLE) is a rheumatologic multi-systemic auto-immune disease particularly affecting joints, skin and kidneys. The aim of this trial was to investigate the effects of rosuvastatin on markers of lipid metabolism and inflammatory parameters in patients with SLE. |
| Ethics approval(s) | Ethics approval received from the Ethical Committee of the Slotervaart Hospital (The Netherlands) on the 29th November 2004. |
| Health condition(s) or problem(s) studied | Systemic lupus erythematosus |
| Intervention | Rosuvastatin 10 mg once daily. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Rosuvastatin |
| Primary outcome measure | Measured at baseline and after three months of treatment: 1. Total cholesterol 2. Low density lipoprotein (LDL) cholesterol 3. C-reactive protein (CRP) 4. Tumour necrotising factor (TNF) |
| Secondary outcome measures | Measured at baseline and after three months of treatment: 1. Interleukin-6 (IL6), interleukin-10 (IL10), interleukin-8 (IL8) 2. Complement C3 and C4q 3. Anti-double stranded deoxyribonucleic acid (anti-dsDNA) 4. Urine protein |
| Overall study start date | 01/01/2005 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 19 |
| Key inclusion criteria | 1. Patients with chronic, non-acute SLE 2. Greater than 18 years old, either sex |
| Key exclusion criteria | 1. Use of statins 2. Pregnancy 3. Raised liver enzymes 4. Recent (less than three months) major surgery or myocardial infarction |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Department of Internal Medicine
Maastricht
6229 HX
Netherlands
6229 HX
Netherlands
Sponsor information
AstraZeneca (The Netherlands)
Industry
Industry
Postbus 599
Zoetermeer
2700 AN
Netherlands
| Phone | +31 (0)79 363 2222 |
|---|---|
| info.nl@astrazeneca.com | |
| Website | http://www.astrazeneca.nl |
"ROR" |
https://ror.org/021tmn508 |
Funders
Funder type
Industry
AstraZeneca (The Netherlands) - unrestricted research grant
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
