Effects of a three-month course of rosuvastatin in patients with Systemic Lupus Erythematosus

ISRCTN	ISRCTN63412511
DOI	https://doi.org/10.1186/ISRCTN63412511
Protocol serial number	N/A
Sponsor	AstraZeneca (The Netherlands)
Funder	AstraZeneca (The Netherlands) - unrestricted research grant

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

Prof Hugo ten Cate
Scientific

Department of Internal Medicine
Academisch Ziekenhuis Maastricht
Maastricht
6229 HX
Netherlands

Email	H.Tencate@BIOCH.unimaas.nl

Primary study design	Interventional
Study design	Randomised, open-labelled, cross-over study
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Rosuvastatin
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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
Completion date	01/01/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Department of Internal Medicine

Maastricht
6229 HX
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan