Condition category
Musculoskeletal Diseases
Date applied
18/09/2006
Date assigned
12/10/2006
Last edited
04/07/2014
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

Dr Braden Manns

ORCID ID

Contact details

Division of Nephrology
Foothills Hospital
1403-29th St NW
Calgary
T2N 2T9
Canada
+1 403 944 1110
Braden.Manns@CalgaryHealthRegion.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18864

Study information

Scientific title

Acronym

SIMPL

Study hypothesis

Comparison of flare of lupus rates in patients randomised to low-dose corticosteroids to those randomised to corticosteroid discontinuation.

Ethics approval

University of Calgary Conjoint Medical Ethics Committee (Canada)

Study design

Blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Systemic lupus erythematosus and lupus nephritis

Intervention

Prednisone/Prednisilone 7.5 mg versus placebo

Intervention type

Drug

Phase

Not Applicable

Drug names

Corticosteroids

Primary outcome measures

Time to flare of SLE

Secondary outcome measures

1. Time to renal flare
2. Differences in quality of life as measured by Short Form - 36 and Euroquol 5D instrument
3. Differences in disease activity as measured by British Isles Lupus Activity Grade and Systemic Lupus Erythematosus Activity Index
4. Differences in disease damage as measured by the Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) damage score
5. Differences in steroid-related adverse events

Overall trial start date

30/09/2006

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. 18 years of age or older
2. American College of Rheumatology defined systemic lupus erythematosus
3. International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis on last renal biopsy
4. In complete or partial remission
5. Currently on corticosteroids
6. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Receiving steroids for a non-Systemic Lupus Erythematosus (SLE) indication
2. Currently pregnant
3. On a form of renal replacement therapy or having received a renal transplantation

Recruitment start date

30/09/2006

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Canada, United Kingdom

Trial participating centre

Division of Nephrology
Calgary
T2N 2T9
Canada

Sponsor information

Organisation

University of Calgary (Canada)

Sponsor details

3330 Hospital Drive NW
Calgary
T2N 4N1
Canada

Sponsor type

University/education

Website

http://www.ucalgary.ca/

Funders

Funder type

Hospital/treatment centre

Funder name

Centre for Advancement of Health (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Division of Nephrology (Canada)

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