Condition category
Musculoskeletal Diseases
Date applied
12/03/2008
Date assigned
26/03/2008
Last edited
26/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hugo ten Cate

ORCID ID

Contact details

Department of Internal Medicine
Academisch Ziekenhuis Maastricht
Maastricht
6229 HX
Netherlands
H.Tencate@BIOCH.unimaas.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Rosuvastatin in SLE

Study hypothesis

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

Ethics approval received from the Ethical Committee of the Slotervaart Hospital (The Netherlands) on the 29th November 2004.

Study design

Randomised, open-labelled, cross-over study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Systemic lupus erythematosus

Intervention

Rosuvastatin 10 mg once daily.

Intervention type

Drug

Phase

Not Specified

Drug names

Rosuvastatin

Primary outcome measures

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 trial start date

01/01/2005

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with chronic, non-acute SLE
2. Greater than 18 years old, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

19

Participant exclusion criteria

1. Use of statins
2. Pregnancy
3. Raised liver enzymes
4. Recent (less than three months) major surgery or myocardial infarction

Recruitment start date

01/01/2005

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Internal Medicine
Maastricht
6229 HX
Netherlands

Sponsor information

Organisation

AstraZeneca (The Netherlands)

Sponsor details

Postbus 599
Zoetermeer
2700 AN
Netherlands
+31 (0)79 363 2222
info.nl@astrazeneca.com

Sponsor type

Industry

Website

http://www.astrazeneca.nl

Funders

Funder type

Industry

Funder name

AstraZeneca (The Netherlands) - unrestricted research grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes