|
ISRCTN
|
ISRCTN35919612
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Maintenance therapy in patients with severe Systemic lupus erythematosus (SLE): The BILAG multi-centre open randomised controlled trial comparing cyclosporin A and azathioprine
|
|
Scientific title
|
|
|
Acronym
|
CYAZ
|
|
Serial number at source
|
G0535
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Systemic lupus erythematosus (SLE)
|
|
Participants - inclusion criteria
|
1. American Rheumatism Association (ARA) criteria for SLE
2. New corticosteroid sparing agent required
3. Patient on 15 mg or more of prednisolone for at least 4 weeks
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/06/1998
|
|
Anticipated end date
|
31/12/2004
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
1. Steroids tapered accordingly to protocol
2. Randomised to azathioprine or cyclosporin A
3. Dose increased according to body weight and tolerability
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Arthritis Research Campaign (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Bridget
Griffiths
|
|
Address
|
Musculoskeletal Unit
Level 2 Freeman Hospitals
High Heaton
|
|
City/town
|
Newcastle upon Tyne
|
|
Zip/Postcode
|
NE7 7DN
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)191 284 3111
|
|
Email
|
bridget.griffiths@ncl.ac.uk
|
|
Sponsor
|
Arthritis Research Campaign (ARC) (UK)
|
|
Address
|
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
|
|
City/town
|
Derbyshire
|
|
Zip/Postcode
|
S41 7TD
|
|
Country
|
United Kingdom
|
|
Email
|
info@arc.org.uk
|
|
Sponsor website:
|
http://www.arc.org.uk
|
|
Date applied
|
18/07/2002
|
|
Last edited
|
28/04/2008
|
|
Date ISRCTN assigned
|
18/07/2002
|